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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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.
Not Available
Phase I/II
Adults
Not Available
Not Available
Ciombor, Kristen
International
Vanderbilt University
08-16-2019
Treatment
VICCGI18172
NCT03184870

Eligibility

18 Years
BOTH
NO
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

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