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

Trial Status: Closed to Accrual

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.

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

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE

Arizona

Phoenix
Mayo Clinic Hospital in Arizona
Status: ACTIVE
Scottsdale
Mayo Clinic in Arizona
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

California

Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Xiomara Menendez
Phone: 323-865-0212
USC / Norris Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Xiomara Menendez
Phone: 323-865-0212
Newport Beach
Hoag Memorial Hospital
Status: ACTIVE
Contact: Cristina de Leon
Phone: 949-764-5543
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Colorado

Aurora
University of Colorado Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Anna Mary Varghese
Phone: 646-888-4308

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: CLOSED_TO_ACCRUAL
University of Pennsylvania / Abramson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

South Carolina

Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Virginia

Charlottesville
University of Virginia Cancer Center
Status: CLOSED_TO_ACCRUAL

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CV202-103
  • Secondary IDs NCI-2017-01723, 2017-001725-40
  • Clinicaltrials.gov ID NCT03184870