Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.

Official Title

A Phase 3 Randomized Clinical Trial of Nivolumab Alone, Nivolumab in Combination With Ipilimumab, or an Investigator's Choice Chemotherapy in Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer Colorectal Neoplasms Microsatellite Instability Leucovorin Bevacizumab Nivolumab Cetuximab Ipilimumab Fluorouracil Oxaliplatin Irinotecan

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:

  • Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study)
  • Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery (Applicable during Part 2 enrollment of the study)
  • Known tumor MSI-H or dMMR status per local standard of practice
  • Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1

Exclusion Criteria:

  • Participants with an active, known or suspected autoimmune disease
  • History of interstitial lung disease or pneumonitis
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)

Other protocol-defined inclusion/exclusion criteria apply

Locations

  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Local Institution not yet accepting 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 Sign up for this study
ID
NCT04008030
Phase
Phase 3
Study Type
Interventional
Last Updated