A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04008030
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    Specified dose on specified days
  • Oxaliplatin — DRUG
    Specified dose on specified days
  • Leucovorin — DRUG
    Specified dose on specified days
  • Fluorouracil — DRUG
    Specified dose on specified days
  • Irinotecan — DRUG
    Specified dose on specified days
  • Bevacizumab — DRUG
    Specified dose on specified days
  • Cetuximab — DRUG
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Aug 5, 2019
Status verified
Sep 2025
Primary completion
Aug 28, 2024
Completion
Jun 10, 2026

Study Design

Enrollment
839 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Nivolumab Monotherapy
  • Experimental: Arm B: Nivolumab + Ipilimumab Combination
  • Active Comparator: Arm C: Investigator's Choice Chemotherapy
    Participants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress

Primary Outcome Measure

Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Lines Centrally Confirmed MSI-H/dMMR [ Time Frame: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months) ]

Locations (9)

FacilityCityStateZIPSite coordinators
Local Institution - 0059Los AngelesCalifornia90033-
Local Institution - 0130SacramentoCalifornia95817-
Local Institution - 0103DenverColorado80218-
Local Institution - 0119Arlington HeightsIllinois60005-
Local Institution - 0060New YorkNew York10065-
Local Institution - 0105PortlandOregon97227-
Local Institution - 0121PittsburghPennsylvania15232-
Local Institution - 0106DallasTexas75246-
Local Institution - 0104RoanokeVirginia24014-

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By research site
Local Institution - 0059· Los Angeles, CALocal Institution - 0130· Sacramento, CALocal Institution - 0103· Denver, COLocal Institution - 0119· Arlington Heights, ILLocal Institution - 0060· New York, NYLocal Institution - 0105· Portland, OR

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