A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors
Purpose
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.
Conditions
- Colorectal Cancer
- Pancreatic Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
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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]) |
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Experimental Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel |
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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 |
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Experimental Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI |
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Experimental Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI |
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Experimental Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI |
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Experimental Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel |
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Experimental Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel |
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Experimental Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel |
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Experimental Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab |
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Experimental Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab |
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Experimental Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy |
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Experimental Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy |
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More Details
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb