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

Completed · Phase 1/Phase 2

Conditions studied: Colorectal Cancer, Pancreatic Cancer

In brief

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.

Key facts

Study ID: NCT03184870
Run by: Bristol-Myers Squibb
People needed: 332
Starts: 2017-08-08
Expected to finish: 2023-06-14
Last updated by the study team: 2025-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Local Institution - 0003 — Birmingham, Alabama, United States
Local Institution - 0026 — Phoenix, Arizona, United States
Local Institution - 0002 — Los Angeles, California, United States
Local Institution - 0025 — Los Angeles, California, United States
Local Institution - 0041 — Orange, California, United States
Local Institution - 0015 — Aurora, Colorado, United States
Local Institution - 0018 — Washington D.C., District of Columbia, United States
Local Institution - 0048 — Brooksville, Florida, United States
Local Institution - 0047 — St. Petersburg, Florida, United States
Local Institution - 0005 — Baltimore, Maryland, United States
Local Institution - 0033 — Boston, Massachusetts, United States
Local Institution - 0027 — Rochester, Minnesota, United States
Local Institution - 0039 — Hattiesburg, Mississippi, United States
Local Institution - 0023 — St Louis, Missouri, United States
Local Institution - 0004 — Hackensack, New Jersey, United States
Local Institution - 0017 — New York, New York, United States
Local Institution - 0024 — Rochester, New York, United States
Local Institution - 0046 — Charlotte, North Carolina, United States
Local Institution - 0044 — Cleveland, Ohio, United States
Local Institution - 0021 — Cleveland, Ohio, United States
Local Institution - 0037 — Allentown, Pennsylvania, United States
Local Institution - 0014 — Philadelphia, Pennsylvania, United States
Local Institution - 0020 — Philadelphia, Pennsylvania, United States
Local Institution - 0045 — Charleston, South Carolina, United States
Local Institution - 0034 — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.