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

Status: Active

Description

This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Histology other than adenocarcinoma (neuroendocrine or acinar cell)
  • Suspected, known, or progressive CNS metastases (Imaging required only if participants are symptomatic)
  • Participants with active, known or suspected autoimmune disease
  • Participants with a 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 CCR2 and/or CCR5 inhibitors, PD-1, PD(L)-1 or CTLA-4 antibodies
  • History of allergy to study treatments or any of its components of the study arm that participant is enrolling

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Name Not Available

Arizona

Phoenix
Mayo Clinic Hospital
Status: Active
Name Not Available
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: Active
Name Not Available
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Name Not Available

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Anna Mary Varghese
Phone: 646-888-4308
Email: varghesa@mskcc.org

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not Available
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Approved
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

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