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An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737475
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : January 25, 2022
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Cancer
Interventions Drug: BMS-986178
Drug: Nivolumab
Drug: Ipilimumab
Biological: Tetanus vaccine
Biological: DPV-001 vaccine
Drug: Cyclophosphamide
Enrollment 166
Recruitment Details  
Pre-assignment Details 165 participants were randomized and treated in Parts 1-8. 1 Participant was randomized and treated in Part 9 Cohort 1. Parts 2B, 2D, 2E, 3B, 3C, and Part 9 Cohort 2 did not enroll any participants.
Arm/Group Title Escalation Part 1: BMS 20 mg Q2W Escalation Part 1: BMS 40 mg Q2W Escalation Part 1: BMS 80 mg Q2W Escalation Part 1: BMS 160 mg Q2W Escalation Part 1: BMS 320 mg Q2W Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Hide Arm/Group Description Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles. Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles. Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles. Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles. Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles. Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles. Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles. Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles. Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles. Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles. Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles. Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles. Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles. Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles. Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles. Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles. Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w). Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy). Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle. Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle. BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles. Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178. BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178. BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178. Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy. Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
Period Title: Overall Study
Started [1] 4 4 4 4 4 7 8 12 8 8 4 10 7 8 6 18 12 6 7 1 6 9 2 2 2 2 1
Completed [2] 3 4 4 3 3 4 8 10 7 8 3 6 5 6 5 15 10 2 5 1 4 8 2 1 1 1 0
Not Completed 1 0 0 1 1 3 0 2 1 0 1 4 2 2 1 3 2 4 2 0 2 1 0 1 1 1 1
Reason Not Completed
Other reasons             0             0             0             0             1             1             0             0             1             0             1             0             0             0             0             0             0             0             0             0             0             1             0             1             1             1             0
Death             1             0             0             1             0             0             0             2             0             0             0             4             2             2             0             2             2             2             1             0             0             0             0             0             0             0             0
Participant withdrew consent             0             0             0             0             0             2             0             0             0             0             0             0             0             0             1             0             0             2             1             0             2             0             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0
Disease Progression             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1
[1]
Treated
[2]
Participants continuing in the study
Arm/Group Title Escalation Part 1: BMS 20 mg Q2W Escalation Part 1: BMS 40 mg Q2W Escalation Part 1: BMS 80 mg Q2W Escalation Part 1: BMS 160 mg Q2W Escalation Part 1: BMS 320 mg Q2W Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine Total
Hide Arm/Group Description Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles. Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles. Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles. Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles. Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles. Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles. Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles. Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles. Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles. Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles. Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles. Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles. Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles. Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles. Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles. Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles. Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w). Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy). Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle. Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle. BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles. Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178. BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178. BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178. Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy. Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles. Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 4 4 7 8 12 8 8 4 10 7 8 6 18 12 6 7 1 6 9 2 2 2 2 1 166
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants 166 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
1
  25.0%
2
  50.0%
1
  25.0%
3
  75.0%
5
  71.4%
3
  37.5%
10
  83.3%
5
  62.5%
5
  62.5%
3
  75.0%
7
  70.0%
4
  57.1%
7
  87.5%
4
  66.7%
8
  44.4%
8
  66.7%
5
  83.3%
7
 100.0%
0
   0.0%
2
  33.3%
2
  22.2%
2
 100.0%
1
  50.0%
0
   0.0%
0
   0.0%
1
 100.0%
100
  60.2%
>=65 years
0
   0.0%
3
  75.0%
2
  50.0%
3
  75.0%
1
  25.0%
2
  28.6%
5
  62.5%
2
  16.7%
3
  37.5%
3
  37.5%
1
  25.0%
3
  30.0%
3
  42.9%
1
  12.5%
2
  33.3%
10
  55.6%
4
  33.3%
1
  16.7%
0
   0.0%
1
 100.0%
4
  66.7%
7
  77.8%
0
   0.0%
1
  50.0%
2
 100.0%
2
 100.0%
0
   0.0%
66
  39.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants 166 participants
Female
1
  25.0%
1
  25.0%
3
  75.0%
1
  25.0%
1
  25.0%
3
  42.9%
6
  75.0%
3
  25.0%
6
  75.0%
2
  25.0%
3
  75.0%
5
  50.0%
4
  57.1%
7
  87.5%
2
  33.3%
1
   5.6%
8
  66.7%
3
  50.0%
2
  28.6%
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
1
  50.0%
1
  50.0%
0
   0.0%
1
 100.0%
67
  40.4%
Male
3
  75.0%
3
  75.0%
1
  25.0%
3
  75.0%
3
  75.0%
4
  57.1%
2
  25.0%
9
  75.0%
2
  25.0%
6
  75.0%
1
  25.0%
5
  50.0%
3
  42.9%
1
  12.5%
4
  66.7%
17
  94.4%
4
  33.3%
3
  50.0%
5
  71.4%
1
 100.0%
4
  66.7%
9
 100.0%
2
 100.0%
1
  50.0%
1
  50.0%
2
 100.0%
0
   0.0%
99
  59.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants 166 participants
Hispanic or Latino
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  28.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6
   3.6%
Not Hispanic or Latino
3
  75.0%
4
 100.0%
4
 100.0%
3
  75.0%
2
  50.0%
6
  85.7%
6
  75.0%
5
  41.7%
3
  37.5%
3
  37.5%
2
  50.0%
7
  70.0%
4
  57.1%
4
  50.0%
5
  83.3%
6
  33.3%
5
  41.7%
3
  50.0%
0
   0.0%
1
 100.0%
4
  66.7%
3
  33.3%
1
  50.0%
2
 100.0%
1
  50.0%
1
  50.0%
1
 100.0%
89
  53.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
2
  50.0%
0
   0.0%
2
  25.0%
6
  50.0%
5
  62.5%
5
  62.5%
2
  50.0%
3
  30.0%
1
  14.3%
4
  50.0%
1
  16.7%
12
  66.7%
7
  58.3%
3
  50.0%
6
  85.7%
0
   0.0%
2
  33.3%
6
  66.7%
1
  50.0%
0
   0.0%
1
  50.0%
1
  50.0%
0
   0.0%
71
  42.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants 166 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
Asian
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
   2.4%
White
2
  50.0%
3
  75.0%
4
 100.0%
4
 100.0%
3
  75.0%
6
  85.7%
8
 100.0%
12
 100.0%
8
 100.0%
8
 100.0%
4
 100.0%
8
  80.0%
7
 100.0%
7
  87.5%
6
 100.0%
18
 100.0%
11
  91.7%
6
 100.0%
7
 100.0%
1
 100.0%
5
  83.3%
8
  88.9%
2
 100.0%
2
 100.0%
2
 100.0%
2
 100.0%
1
 100.0%
155
  93.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.2%
1.Primary Outcome
Title The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Hide Description

The number of participants experiencing dose-limiting toxicities (DLTs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.

DLTs are defined based on the incidence, severity, and duration of adverse events (AEs) for which no clear alternative cause is identified. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.

Time Frame From first dose to 28 days after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants (Parts 1-9)
Arm/Group Title Escalation Part 1: BMS 20 mg Q2W Escalation Part 1: BMS 40 mg Q2W Escalation Part 1: BMS 80 mg Q2W Escalation Part 1: BMS 160 mg Q2W Escalation Part 1: BMS 320 mg Q2W Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Hide Arm/Group Description:
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
Overall Number of Participants Analyzed 4 4 4 4 4 7 8 12 8 8 4 10 7 8 6 18 12 6 7 1 6 9 2 2 2 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title The Number of Participants Experiencing Adverse Events (AEs)
Hide Description

The number of participants experiencing adverse events (AEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.

Time Frame From first dose to 100 days after last dose (up to approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants (Parts 1-9)
Arm/Group Title Escalation Part 1: BMS 20 mg Q2W Escalation Part 1: BMS 40 mg Q2W Escalation Part 1: BMS 80 mg Q2W Escalation Part 1: BMS 160 mg Q2W Escalation Part 1: BMS 320 mg Q2W Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Hide Arm/Group Description:
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
Overall Number of Participants Analyzed 4 4 4 4 4 7 8 12 8 8 4 10 7 8 6 18 12 6 7 1 6 9 2 2 2 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
4
 100.0%
4
 100.0%
3
  75.0%
4
 100.0%
7
 100.0%
8
 100.0%
12
 100.0%
7
  87.5%
8
 100.0%
4
 100.0%
10
 100.0%
7
 100.0%
8
 100.0%
6
 100.0%
18
 100.0%
12
 100.0%
6
 100.0%
6
  85.7%
1
 100.0%
6
 100.0%
9
 100.0%
2
 100.0%
2
 100.0%
2
 100.0%
2
 100.0%
1
 100.0%
3.Primary Outcome
Title The Number of Participants Experiencing Serious Adverse Events (SAEs)
Hide Description

The number of participants experiencing serious adverse events (SAEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.

A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event.

Time Frame From first dose to 100 days after last dose (up to approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants (Parts 1-9)
Arm/Group Title Escalation Part 1: BMS 20 mg Q2W Escalation Part 1: BMS 40 mg Q2W Escalation Part 1: BMS 80 mg Q2W Escalation Part 1: BMS 160 mg Q2W Escalation Part 1: BMS 320 mg Q2W Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Hide Arm/Group Description:
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
Overall Number of Participants Analyzed 4 4 4 4 4 7 8 12 8 8 4 10 7 8 6 18 12 6 7 1 6 9 2 2 2 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
4
 100.0%
2
  50.0%
3
  75.0%
3
  75.0%
3
  42.9%
6
  75.0%
7
  58.3%
4
  50.0%
5
  62.5%
2
  50.0%
6
  60.0%
6
  85.7%
5
  62.5%
2
  33.3%
11
  61.1%
7
  58.3%
4
  66.7%
4
  57.1%
1
 100.0%
6
 100.0%
5
  55.6%
0
   0.0%
1
  50.0%
1
  50.0%
1
  50.0%
1
 100.0%
4.Primary Outcome
Title The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Hide Description The number of participants experiencing adverse events (AEs) leading to discontinuation of study drug to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
Time Frame From first dose to 100 days after last dose (up to approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants (Parts 1-9)
Arm/Group Title Escalation Part 1: BMS 20 mg Q2W Escalation Part 1: BMS 40 mg Q2W Escalation Part 1: BMS 80 mg Q2W Escalation Part 1: BMS 160 mg Q2W Escalation Part 1: BMS 320 mg Q2W Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Hide Arm/Group Description:
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
Overall Number of Participants Analyzed 4 4 4 4 4 7 8 12 8 8 4 10 7 8 6 18 12 6 7 1 6 9 2 2 2 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
2
  20.0%
0
   0.0%
2
  25.0%
0
   0.0%
0
   0.0%
2
  16.7%
0
   0.0%
2
  28.6%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title The Number of Participant Deaths
Hide Description The number of deaths in each arm to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.
Time Frame From first dose to study completion (up to approximately 4 years 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants (Parts 1-9)
Arm/Group Title Escalation Part 1: BMS 20 mg Q2W Escalation Part 1: BMS 40 mg Q2W Escalation Part 1: BMS 80 mg Q2W Escalation Part 1: BMS 160 mg Q2W Escalation Part 1: BMS 320 mg Q2W Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Hide Arm/Group Description:
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
Overall Number of Participants Analyzed 4 4 4 4 4 7 8 12 8 8 4 10 7 8 6 18 12 6 7 1 6 9 2 2 2 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
4
 100.0%
3
  75.0%
4
 100.0%
4
 100.0%
3
  42.9%
7
  87.5%
11
  91.7%
6
  75.0%
6
  75.0%
4
 100.0%
9
  90.0%
7
 100.0%
8
 100.0%
2
  33.3%
16
  88.9%
11
  91.7%
3
  50.0%
3
  42.9%
0
   0.0%
5
  83.3%
4
  44.4%
2
 100.0%
2
 100.0%
1
  50.0%
1
  50.0%
1
 100.0%
6.Primary Outcome
Title The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
Hide Description

The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.

Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time

Time Frame From baseline to 100 days after last dose (up to approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with on-treatment laboratory results and CTC grade criteria available (Parts 1-9)
Arm/Group Title Escalation Part 1: BMS 20 mg Q2W Escalation Part 1: BMS 40 mg Q2W Escalation Part 1: BMS 80 mg Q2W Escalation Part 1: BMS 160 mg Q2W Escalation Part 1: BMS 320 mg Q2W Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Hide Arm/Group Description:
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
Overall Number of Participants Analyzed 4 4 4 4 4 7 8 12 8 8 4 10 7 8 6 18 12 6 7 1 6 9 2 2 2 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
HEMOGLOBIN GRADE 1 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
2
  50.0%
0
   0.0%
4
 100.0%
1
  25.0%
2
  50.0%
1
  14.3%
4
  50.0%
3
  25.0%
3
  37.5%
6
  75.0%
3
  75.0%
4
  40.0%
2
  28.6%
5
  62.5%
1
  16.7%
9
  50.0%
4
  33.3%
1
  16.7%
3
  42.9%
1
 100.0%
2
  33.3%
7
  77.8%
1
  50.0%
1
  50.0%
1
  50.0%
1
  50.0%
1
 100.0%
HEMOGLOBIN GRADE 2 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
1
  25.0%
2
  50.0%
0
   0.0%
2
  50.0%
1
  25.0%
4
  57.1%
2
  25.0%
5
  41.7%
2
  25.0%
0
   0.0%
1
  25.0%
6
  60.0%
3
  42.9%
1
  12.5%
4
  66.7%
6
  33.3%
5
  41.7%
2
  33.3%
2
  28.6%
0
   0.0%
2
  33.3%
2
  22.2%
1
  50.0%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
HEMOGLOBIN GRADE 3 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
1
  25.0%
1
  25.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
  14.3%
1
  12.5%
1
   8.3%
2
  25.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
  14.3%
2
  25.0%
1
  16.7%
3
  16.7%
1
   8.3%
2
  33.3%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
1
  50.0%
0
   0.0%
PLATELET COUNT GRADE 1 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 0 participants
1
  25.0%
1
  25.0%
1
  25.0%
1
  25.0%
0
   0.0%
1
  14.3%
2
  25.0%
1
   8.3%
1
  12.5%
0
   0.0%
0
   0.0%
1
  10.0%
2
  28.6%
1
  12.5%
2
  33.3%
4
  22.2%
3
  25.0%
1
  16.7%
1
  14.3%
0
   0.0%
1
  16.7%
2
  22.2%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
PLATELET COUNT GRADE 2 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 00 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
PLATELET COUNT GRADE 3 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
LEUKOCYTES GRADE 1 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 0 participants
1
  25.0%
1
  25.0%
2
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  25.0%
1
   8.3%
2
  25.0%
1
  12.5%
0
   0.0%
1
  10.0%
1
  14.3%
3
  37.5%
2
  33.3%
2
  11.1%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
LEUKOCYTES GRADE 2 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
  10.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
2
  22.2%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
LEUKOCYTES GRADE 3 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
  16.7%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
LEUKOCYTES GRADE 4 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 1 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 0 participants
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
3
  37.5%
0
   0.0%
2
  25.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  11.1%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 2 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 3 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 4 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
7.Primary Outcome
Title The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
Hide Description

The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.

Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time

Time Frame From baseline to 100 days after last dose (up to approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with on-treatment laboratory results and CTC grade criteria available (Parts 1-9)
Arm/Group Title Escalation Part 1: BMS 20 mg Q2W Escalation Part 1: BMS 40 mg Q2W Escalation Part 1: BMS 80 mg Q2W Escalation Part 1: BMS 160 mg Q2W Escalation Part 1: BMS 320 mg Q2W Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Hide Arm/Group Description:
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
Overall Number of Participants Analyzed 4 4 4 4 4 7 8 12 8 8 4 10 7 8 6 18 12 6 7 1 6 9 2 2 2 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
ALKALINE PHOSPHATASE GRADE 1 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
2
  50.0%
2
  50.0%
2
  50.0%
1
  25.0%
3
  75.0%
5
  71.4%
2
  25.0%
5
  41.7%
6
  75.0%
4
  50.0%
2
  50.0%
3
  30.0%
3
  42.9%
4
  50.0%
0
   0.0%
7
  38.9%
6
  50.0%
2
  33.3%
1
  14.3%
0
   0.0%
3
  50.0%
2
  22.2%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
ALKALINE PHOSPHATASE GRADE 2 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
1
  25.0%
1
  25.0%
1
  25.0%
2
  50.0%
0
   0.0%
1
  14.3%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
2
  20.0%
0
   0.0%
1
  12.5%
1
  16.7%
3
  16.7%
1
   8.3%
0
   0.0%
1
  14.3%
1
 100.0%
1
  16.7%
2
  22.2%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
1
 100.0%
ALKALINE PHOSPHATASE GRADE 3 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  25.0%
2
  16.7%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
  16.7%
2
  11.1%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
ASPARTATE AMINOTRANSFERASE GRADE 1 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
2
  50.0%
3
  75.0%
1
  25.0%
1
  25.0%
1
  25.0%
3
  42.9%
4
  50.0%
2
  16.7%
1
  12.5%
2
  25.0%
0
   0.0%
4
  40.0%
2
  28.6%
2
  25.0%
2
  33.3%
10
  55.6%
5
  41.7%
4
  66.7%
3
  42.9%
0
   0.0%
5
  83.3%
2
  22.2%
0
   0.0%
1
  50.0%
1
  50.0%
0
   0.0%
1
 100.0%
ASPARTATE AMINOTRANSFERASE GRADE 2 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
0
   0.0%
0
   0.0%
1
  25.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
ASPARTATE AMINOTRANSFERASE GRADE 3 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
2
  25.0%
1
   8.3%
1
  12.5%
0
   0.0%
2
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ASPARTATE AMINOTRANSFERASE GRADE 4 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
1
  25.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALANINE AMINOTRANSFERASE GRADE 1 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
1
  25.0%
3
  75.0%
2
  50.0%
2
  50.0%
0
   0.0%
2
  28.6%
4
  50.0%
1
   8.3%
2
  25.0%
0
   0.0%
1
  25.0%
4
  40.0%
1
  14.3%
1
  12.5%
2
  33.3%
7
  38.9%
4
  33.3%
3
  50.0%
1
  14.3%
0
   0.0%
3
  50.0%
3
  33.3%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
1
 100.0%
ALANINE AMINOTRANSFERASE GRADE 2 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
1
  25.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
1
  12.5%
1
   8.3%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALANINE AMINOTRANSFERASE GRADE 3 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALANINE AMINOTRANSFERASE GRADE 4 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BILIRUBIN, TOTAL GRADE 1 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
1
   8.3%
0
   0.0%
0
   0.0%
1
  25.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  11.1%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BILIRUBIN, TOTAL GRADE 2 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
  50.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
1
 100.0%
BILIRUBIN, TOTAL GRADE 3 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants 7 participants 8 participants 6 participants 18 participants 12 participants 6 participants 7 participants 1 participants 6 participants 9 participants 2 participants 2 participants 2 participants 2 participants 1 participants
1
  25.0%
1
  25.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BILIRUBIN, TOTAL GRADE 4 Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 7 participants 8 participants 12 participants 8 participants 8 participants 4 participants 10 participants