April 8, 2016
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April 14, 2016
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October 8, 2020
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June 16, 2016
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July 11, 2023 (Final data collection date for primary outcome measure)
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- Incidence of AEs (adverse events) [ Time Frame: Approximately 4 years. ]
- Incidence of SAEs (serious adverse events) [ Time Frame: Approximately 4 years. ]
- Incidence of AEs leading to discontinuation [ Time Frame: Approximately 4 years. ]
- Incidence of deaths [ Time Frame: Approximately 4 years. ]
- Incidence of clinical laboratory test abnormalities - Hematology [ Time Frame: Approximately 4 years. ]
- Incidence of clinical laboratory test abnormalities - Chemistry [ Time Frame: Approximately 4 years. ]
- Incidence of clinical laboratory test abnormalities - Urinalysis [ Time Frame: Approximately 4 years. ]
- Incidence of clinical laboratory test abnormalities - Serology [ Time Frame: Approximately 4 years. ]
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Incidence of AE's (adverse events) and SAE's (serious adverse events), AE's leading to discontinuation, deaths and clinical laboratory test abnormalities [ Time Frame: Approximately 4 years. ]
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- Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]
- Cmax (maximum observed serum concentration) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Tmax (time of maximum observed concentration) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- AUC(0-t) (area under the concentration-time curve from time zero to the time) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- AUC(TAU) (area under the concentration-time curve in 1 dosing interval) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Ctau (the observed concentration at the end of a dosing interval) for BMS- 986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- CLT (total body clearance) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Css-avg [average concentration over a dosing interval (AUC(TAU)/tau)] for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- AI [ratio of an exposure measure at steady state to that after the first dose (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS- 986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- T-HALFeff [effective elimination half-life to explain degree of accumulation for a specific exposure measure (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Ctrough [trough observed plasma concentrations (this includes pre-dose concentrations (C0) and Ctau)] for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Immunogenicity assessed by number of participants with positive anti-drug antibodies (ADA) to BMS-986178 [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Immunogenicity assessed by number of participants with positive ADA to nivolumab [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Immunogenicity assessed by number of participants with positive ADA to ipilimumab [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Number of participants showing a change in one of the pharmacodynamic biomarkers of BMS-986178 dosed in combination with nivo or nivo alone (Part 8) and sustained T cell expansion with DPV-001 in combination with nivo with or without BMS-986178 (Part 9) [ Time Frame: Up to 2 years ]
nivo (nivolumab)
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- Cmax (maximum observed serum concentration) for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Tmax (time of maximum observed concentration) for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- AUC(0-t) (area under the concentration-time curve from time zero to the time) for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- AUC(TAU) (area under the concentration-time curve in 1 dosing interval) for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Ctau (the observed concentration at the end of a dosing interval) for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- CLT (total body clearance) for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Css-avg [average concentration over a dosing interval (AUC(TAU)/tau)] for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- AI [ratio of an exposure measure at steady state to that after the first dose (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- T-HALFeff [effective elimination half-life to explain degree of accumulation for a specific exposure measure (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Ctrough [trough observed plasma concentrations (this includes pre-dose concentrations (C0) and Ctau)] for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Immunoassay of anti-nivolumab antibody in combination with anti-BMS- 986178 antibody [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Immunoassay of anti-ipilimumab antibody in combination with anti-BMS-986178 antibody [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
- Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]
- Progression Free Survival Rate (PFSR) [ Time Frame: Approximately 2 years ]
- Immunoassay of anti-BMS-986178 antibody alone [ Time Frame: Approximately 100 days after 6 months of treatment ]
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Not Provided
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Not Provided
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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
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A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination With Nivolumab and/or Ipilimumab in Subjects With Advanced Solid Tumors
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The purpose of the study is to determine the safety and tumor-shrinking ability of experimental medication BMS-986178, when given by itself or in combination with Nivolumab and/or Ipilimumab, in participants with solid cancers that are advanced or have spread.
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Not Provided
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Interventional
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Phase 1 Phase 2
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
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Advanced Cancer
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- Drug: BMS-986178
Specified dose on specified days
- Drug: Nivolumab
Specified dose on specified days
- Drug: Ipilimumab
Specified dose on specified days
- Biological: Tetanus vaccine
Specified dose on specified days
- Biological: DPV-001 vaccine
DPV-001 (UbiLT3 and UbiLT6): Specified dose on specified days
- Drug: Cyclophosphamide
Specified dose on specified days
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Not Provided
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Recruiting
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207
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212
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October 14, 2024
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July 11, 2023 (Final data collection date for primary outcome measure)
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
For Part 9 (only arm open for enrollment):
- Stage IV metastatic or unresectable triple negative breast cancer (TNBC) with zero or one prior systemic therapies in the advanced metastatic setting
- Participants with < 12 months from receipt of last curative-intent chemotherapy are allowed; curative chemotherapy will be considered first-line therapy
- Prior receipt of chemotherapy in the (neo)adjuvant setting is acceptable, as long as completed greater than 6 months from start of treatment
- Tumor biopsy samples (mandatory pre- and on-treatment biopsies) are required for all participants enrolled
- Must have histologic or cytologic confirmation of a malignancy that is advanced (metastatic, recurrent, refractory, and/or unresectable) with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Men and women must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
- Must be immunotherapy treatment naïve, including no prior therapy with T cell immune checkpoint blocker (anti-PDL1, anti-PD1). Prior receipt of intralymphatic cytokine therapy (IRX-2) is acceptable (Part 9 only)
- Other active malignancy requiring concurrent intervention
- Prior therapy with any agent specifically targeting T-cell co-stimulation pathways such as anti-OX40 antibody, anti-CD137, anti- glucocorticoid-induced TNFR-related gene (anti-GITR) antibody, and anti-CD27
- Known or underlying medical or psychiatric condition and/or social reason that, in the opinion of the investigator or Sponsor, could make the administration of study drug hazardous to the participant or could adversely affect the ability of the participant to comply with or tolerate the study
Other protocol-defined inclusion/exclusion criteria apply
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: |
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Clinical.Trials@bms.com |
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Contact: First line of the email MUST contain NCT# and Site #. |
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Canada, France, Israel, Italy, Netherlands, Spain, United States
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NCT02737475
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CA012-004 2015-004816-39 ( EudraCT Number )
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No
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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Not Provided
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Not Provided
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Study Director: |
Bristol-Myers Squibb |
Bristol-Myers Squibb |
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Bristol-Myers Squibb
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October 2020
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