An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03377361
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Trametinib — DRUG
    Specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    Specified dose on specified days
  • Regorafenib — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.

Key Dates

Start date
Jan 31, 2018
Status verified
Nov 2025
Primary completion
Nov 4, 2024
Completion
Nov 4, 2024

Study Design

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

Arms

  • Experimental: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib
  • Experimental: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib
  • Experimental: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib
  • Experimental: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib
  • Experimental: Part 2 Cohort 5 (3L): Regorafenib
  • Experimental: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib

Primary Outcome Measure

Dose Limiting Toxicities in Part 1 and Part 1A [ Time Frame: 4 weeks for Doublet Reginmen and 8 weeks for triplet Regimen ]

Locations (16)

FacilityCityStateZIPSite coordinators
Local Institution - 0022BirminghamAlabama35249-
Local Institution - 0027Los AngelesCalifornia90033-
Local Institution - 0067Los AngelesCalifornia90089-
Local Institution - 0001San FranciscoCalifornia94158-
Local Institution - 0107GainesvilleFlorida32610-
Local Institution - 0111MiamiFlorida33136-
Local Institution - 0028BaltimoreMaryland21287-
Local Institution - 0116HattiesburgMississippi39401-7233-
Local Institution - 0103St LouisMissouri63110-
Local Institution - 0104New YorkNew York10016-
Local Institution - 0029CharlotteNorth Carolina28204-
Local Institution - 0100LancasterPennsylvania17604-
Local Institution - 0003PhiladelphiaPennsylvania19104-
Thomas Jefferson University - Clinical Research InstitutePhiladelphiaPennsylvania19107-
Local Institution - 0101TempleTexas76508-
Local Institution - 0002MadisonWisconsin53792-0001-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Local Institution - 0022· Birmingham, ALLocal Institution - 0027· Los Angeles, CALocal Institution - 0067· Los Angeles, CALocal Institution - 0001· San Francisco, CALocal Institution - 0107· Gainesville, FLLocal Institution - 0111· Miami, FL

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