A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02060188
Phase
PHASE2
Status
Completed

Conditions

  • Microsatellite Stable Colorectal Cancer
  • Microsatellite Unstable Colorectal Cancer
  • Mismatch Repair Deficient Colorectal Cancer
  • Mismatch Repair Proficient Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    Specified dose on specified days
  • Nivolumab — DRUG
    Specified dose on specified days
  • Cobimetinib — DRUG
    Specified dose on specified days
  • Daratumumab — DRUG
    Specified dose on specified days
  • BMS-986016 — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.

Key Dates

Start date
Mar 12, 2014
Status verified
Oct 2025
Primary completion
Oct 22, 2024
Completion
Oct 22, 2024

Study Design

Enrollment
385 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab Monotherapy
  • Experimental: Nivolumab + Ipilimumab
  • Experimental: Nivolumab + Ipilimumab Cohort C3
  • Experimental: Nivolumab + Ipilimumab + Cobimetinib Cohort C4
  • Experimental: Nivolumab + BMS-986016 Cohort C5
  • Experimental: Nivolumab + Daratumumab Cohort C6

Primary Outcome Measure

Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment [ Time Frame: From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months) ]

Locations (14)

FacilityCityStateZIPSite coordinators
Local Institution - 0028GilbertArizona85234-
Local Institution - 0004Los AngelesCalifornia90033-
Local Institution - 0001San FranciscoCalifornia94115-
Local Institution - 0008AtlantaGeorgia30322-
Local Institution - 0002BostonMassachusetts02114-
Local Institution - 0036BostonMassachusetts02114-
Local Institution - 0034MinneapolisMinnesota55407-
Local Institution - 0024DurhamNorth Carolina27710-
Local Institution - 0029Winston-SalemNorth Carolina27103-
Local Institution - 0005PortlandOregon97213-
Local Institution - 0041AllentownPennsylvania18103-
Local Institution - 0013PittsburghPennsylvania15232-
Local Institution - 0006NashvilleTennessee37232-
Local Institution - 0003HoustonTexas77030-4009-

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By research site
Local Institution - 0028· Gilbert, AZLocal Institution - 0004· Los Angeles, CALocal Institution - 0001· San Francisco, CALocal Institution - 0008· Atlanta, GALocal Institution - 0002· Boston, MALocal Institution - 0036· Boston, MA

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