Summary

for people ages 18 years and up (full criteria)
at UC Irvine
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors

Keywords

Colorectal Cancer Pancreatic Cancer Gemcitabine Paclitaxel Albumin-Bound Paclitaxel Nivolumab Irinotecan Fluorouracil BMS-813160 Nab-paclitaxel 5-fluorouracil (5-FU) Leucovorin Monotherapy

Eligibility

For people ages 18 years and up

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Other protocol defined inclusion/exclusion criteria could apply

Locations

  • Uc Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States
  • Usc/Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
ID
NCT03184870
Phase
Phase 1/2
Study Type
Interventional
Last Updated