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Active, Not Recruiting

A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors - CV202-103

Updated: 16 April, 2021   |   ClinicalTrials.gov

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Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI
Drug: BMS-813160 Drug: Irinotecan Drug: Leucovorin Drug: 5-fluorouracil (5-FU)
Experimental: Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel
Drug: BMS-813160 Drug: Gemcitabine Drug: Nab-paclitaxel
Experimental: Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab
Biological: Nivolumab Drug: BMS-813160
Experimental: Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI
Drug: BMS-813160 Drug: Leucovorin Drug: 5-fluorouracil (5-FU) Drug: Irinotecan
Experimental: Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI
Drug: 5-fluorouracil (5-FU) Drug: BMS-813160 Drug: Irinotecan Drug: Leucovorin
Experimental: Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI
Drug: 5-fluorouracil (5-FU) Drug: Irinotecan Drug: Leucovorin
Experimental: Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel
Drug: BMS-813160 Drug: Gemcitabine Drug: Nab-paclitaxel
Experimental: Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel
Drug: BMS-813160 Drug: Gemcitabine Drug: Nab-paclitaxel Biological: Nivolumab
Experimental: Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel
Drug: Gemcitabine Drug: Nab-paclitaxel
Experimental: Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab
Biological: Nivolumab Drug: BMS-813160
Experimental: Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab
Biological: Nivolumab Drug: BMS-813160
Experimental: Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy
Drug: BMS-813160
Experimental: Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy
Drug: BMS-813160

Key Eligibility 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

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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com