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A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors

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: NCT03184870
Recruitment Status : Active, not recruiting
First Posted : June 14, 2017
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to evaluate the safety profile, tolerability, drug levels, drug effects, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab or chemotherapy plus nivolumab in participants with metastatic colorectal and pancreatic cancers.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Pancreatic Cancer Drug: BMS-813160 Biological: Nivolumab Drug: Nab-paclitaxel Drug: Gemcitabine Drug: 5-fluorouracil (5-FU) Drug: Leucovorin Drug: Irinotecan Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Actual Study Start Date : August 8, 2017
Estimated Primary Completion Date : February 27, 2023
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI
FOLFIRI: FOL (folinic acid [leucovorin]) F (fluorouracil [5-fluorouracil]) IRI (irinotecan [CAMPTOSAR])
Drug: BMS-813160
Specified dose on specified days

Drug: 5-fluorouracil (5-FU)
Specified dose on specified days

Drug: Leucovorin
Specified dose on specified days

Drug: Irinotecan
Specified dose on specified days

Experimental: Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel Drug: BMS-813160
Specified dose on specified days

Drug: Nab-paclitaxel
Specified dose on specified days

Drug: Gemcitabine
Specified dose on specified days

Experimental: Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab
2L: Second-line 2/3L: Second/third-line MSS: Microsatellite stable
Drug: BMS-813160
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Experimental: Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI Drug: BMS-813160
Specified dose on specified days

Drug: 5-fluorouracil (5-FU)
Specified dose on specified days

Drug: Leucovorin
Specified dose on specified days

Drug: Irinotecan
Specified dose on specified days

Experimental: Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI Drug: BMS-813160
Specified dose on specified days

Drug: 5-fluorouracil (5-FU)
Specified dose on specified days

Drug: Leucovorin
Specified dose on specified days

Drug: Irinotecan
Specified dose on specified days

Experimental: Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI Drug: 5-fluorouracil (5-FU)
Specified dose on specified days

Drug: Leucovorin
Specified dose on specified days

Drug: Irinotecan
Specified dose on specified days

Experimental: Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel Drug: BMS-813160
Specified dose on specified days

Drug: Nab-paclitaxel
Specified dose on specified days

Drug: Gemcitabine
Specified dose on specified days

Experimental: Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel Drug: BMS-813160
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Nab-paclitaxel
Specified dose on specified days

Drug: Gemcitabine
Specified dose on specified days

Experimental: Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel Drug: Nab-paclitaxel
Specified dose on specified days

Drug: Gemcitabine
Specified dose on specified days

Experimental: Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab Drug: BMS-813160
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Experimental: Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab Drug: BMS-813160
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Experimental: Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy Drug: BMS-813160
Specified dose on specified days

Experimental: Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy Drug: BMS-813160
Specified dose on specified days




Primary Outcome Measures :
  1. Incidence of Adverse events (AEs) [ Time Frame: Approximately 4 years ]
    Part 1 only

  2. Incidence of Serious adverse events (SAEs) [ Time Frame: Approximately 4 years ]
    Part 1 only

  3. Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria [ Time Frame: Approximately 6 months ]
    Part 1 only

  4. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 4 years ]
    Part 1 only

  5. Incidence of Death [ Time Frame: Approximately 4 years ]
    Part 1 only

  6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Approximately 4 years ]
    Part 1 only

  7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Approximately 4 years ]
    Part 1 only

  8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Approximately 4 years ]
    Part 1 only

  9. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [ Time Frame: Approximately 4 years ]
    Part 1 only PR interval: The time from the onset of the P wave to the start of the QRS complex

  10. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval [ Time Frame: Approximately 4 years ]
    Part 1 only QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization

  11. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [ Time Frame: Approximately 4 years ]
    Part 1 only QT interval: Measured from the beginning of the QRS complex to the end of the T wave

  12. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval [ Time Frame: Approximately 4 years ]
    Part 1 only QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)

  13. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Approximately 4 years ]
    Part 1 only

  14. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Approximately 4 years ]
    Part 1 only

  15. Incidence of clinically significant changes in vital signs: Pulse oximetry [ Time Frame: Approximately 4 years ]
    Part 1 only

  16. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Approximately 4 years ]
    Part 1 only

  17. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Approximately 4 years ]
    Part 1 only

  18. Decrease in regulatory T cells (Treg) or tumor-associated macrophage (TAM) in tumor samples [ Time Frame: Approximately 4 years ]
    Part 1 only

  19. Overall response rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 2 years ]
    Part 2 only

  20. Median duration of response (DOR) [ Time Frame: Approximately 2 years ]
    Part 2 only

  21. Progression free survival (PFS) rate [ Time Frame: At 24 weeks ]
    Part 2 only


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Approximately 2 years ]
    Part 1 only

  2. Median duration of response (DOR) [ Time Frame: Approximately 2 years ]
    Part 1 only

  3. Progression free survival (PFS) rate [ Time Frame: At 24 weeks ]
    Part 1 only

  4. Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 4 years ]
    Part 1 only

  5. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Approximately 4 years ]
    Part 1 only

  6. Trough observed plasma concentration (Ctrough) [ Time Frame: Approximately 4 years ]
    Part 1 only

  7. Observed plasma concentration at 24 hours post dose (C24) [ Time Frame: Approximately 4 years ]
    Part 1 only

  8. Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)] [ Time Frame: Approximately 4 years ]
    Part 1 only

  9. Area under the concentration-time curve from time 0 to 24 hours post dose [AUC(0-24)] [ Time Frame: Approximately 4 years ]
    Part 1 only

  10. Apparent total body clearance (CLT/F) [ Time Frame: Approximately 4 years ]
    Part 1 only

  11. Accumulation index, calculated based on ratio of AUC(0-24) and Cmax at steady state to after the first dose (AI) [ Time Frame: Approximately 4 years ]
    Part 1 only

  12. Renal clearance (CLR) [ Time Frame: Approximately 4 years ]
    Part 1 only

  13. Percent urinary recovery over 24 hours corrected for molecular weight (%UR) [ Time Frame: Approximately 4 years ]
    Part 1 only

  14. Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax) [ Time Frame: Approximately 4 years ]
    Part 1 only

  15. Ratio of metabolite AUC(0-24) to parent AUC(0-24), corrected for molecular weight [MR_AUC(0-24)] [ Time Frame: Approximately 4 years ]
    Part 1 only

  16. Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy [ Time Frame: Approximately 4 years ]
    Part 1 only

  17. Incidence of Adverse events (AEs) [ Time Frame: Approximately 4 years ]
    Part 2 only

  18. Incidence of Serious adverse events (SAEs) [ Time Frame: Approximately 4 years ]
    Part 2 only

  19. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 4 years ]
    Part 2 only

  20. Incidence of Death [ Time Frame: Approximately 4 years ]
    Part 2 only

  21. Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria [ Time Frame: Approximately 6 months ]
    Part 2 Cohort 3b only

  22. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Approximately 4 years ]
    Part 2 only

  23. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Approximately 4 years ]
    Part 2 only

  24. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Approximately 4 years ]
    Part 2 only

  25. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Approximately 4 years ]
    Part 2 only

  26. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Approximately 4 years ]
    Part 2 only

  27. Incidence of clinically significant changes in vital signs: Pulse oximetry [ Time Frame: Approximately 4 years ]
    Part 2 only

  28. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Approximately 4 years ]
    Part 2 only

  29. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Approximately 4 years ]
    Part 2 only

  30. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [ Time Frame: Approximately 4 years ]
    Part 2 only PR interval: The time from the onset of the P wave to the start of the QRS complex

  31. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval [ Time Frame: Approximately 4 years ]
    Part 2 only QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization

  32. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [ Time Frame: Approximately 4 years ]
    Part 2 only QT interval: Measured from the beginning of the QRS complex to the end of the T wave

  33. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval [ Time Frame: Approximately 4 years ]
    Part 2 only QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)

  34. Decrease in regulatory T cells (Treg) & tumor-associated macrophages (TAM) in tumor samples [ Time Frame: Approximately 4 years ]
    Part 2 only



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Must have metastatic colorectal or pancreatic cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  • Ability to swallow pills or capsules
  • Required to undergo mandatory pre and on-treatment biopsies
  • Adequate marrow function
  • Adequate other organ functions
  • Ability to comply with study visits, treatment, procedures, pharmacokinetic (PK) and pharmacodynamic (PD) sample collection, and required study follow-up

Exclusion Criteria:

  • Histology other than adenocarcinoma (neuroendocrine or acinar cell)
  • Suspected, known, or central nervous system (CNS) metastases (Imaging required only if participants are symptomatic)
  • Active, known or suspected autoimmune disease
  • Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
  • Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
  • Prior treatment with cysteine-cysteine chemokine receptor 2 (CCR2) and/or cysteine-cysteine chemokine receptor 5 (CCR5) inhibitors, programmed death-1 receptor (PD-1), programmed death-ligand 1 [PD(L)-1] or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibodies
  • History of allergy to study treatments or any of its components of the study arm that participant is enrolling

Other protocol-defined inclusion/exclusion criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184870


Locations
Show Show 40 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03184870    
Other Study ID Numbers: CV202-103
2017-001725-40 ( EudraCT Number )
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leucovorin
Gemcitabine
Paclitaxel
Fluorouracil
Nivolumab
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients