An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03414983
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — 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
  • Bevacizumab — DRUG
    Specified dose on specified days

Study Details

This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (mCRC).

Key Dates

Start date
Feb 20, 2018
Status verified
Oct 2023
Primary completion
Feb 1, 2021
Completion
Dec 28, 2022

Study Design

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

Arms

  • Experimental: Arm A
    Nivo + SOC
  • Active Comparator: Arm B
    SOC

Primary Outcome Measure

Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) [ Time Frame: From randomization to up to the date of the first documented progression (up to 16 months) ]

Locations (35)

FacilityCityStateZIPSite coordinators
Uab Comprehensive Cancer CenterBirminghamAlabama35294-3300-
Local Institution - 0004Los AngelesCalifornia90033-
Local Institution - 0010AuroraColorado80045-
Local Institution - 0027DenverColorado80218-
Local Institution - 0020New HavenConnecticut06520-
Local Institution - 0039MiamiFlorida33176-
Local Institution - 0047St. PetersburgFlorida33705-
Local Institution - 0033Arlington HeightsIllinois60005-
Local Institution - 0044IndianapolisIndiana46260-
Local Institution - 0021BethesdaMaryland20817-
Local Institution - 0003BostonMassachusetts02114-
Local Institution - 0049BostonMassachusetts02114-
Local Institution - 0052BostonMassachusetts02114-
Local Institution - 0053BostonMassachusetts02114-
Local Institution - 0035MinneapolisMinnesota55404-
Local Institution - 0002RochesterMinnesota55905-
Local Institution - 0032PapillionNebraska68046-
Local Institution - 0029HendersonNevada89074-
Local Institution - 0031Johnson CityNew York13790-
Local Institution - 0046New YorkNew York10016-
Levine Cancer InstituteCharlotteNorth Carolina28262-
Local Institution - 0038PortlandOregon97227-
Local Institution - 0005PhiladelphiaPennsylvania19104-
Local Institution - 0024PittsburghPennsylvania15212-
Local Institution - 0023Sioux FallsSouth Dakota57104-
Erlanger Oncology & Hematology - Univ. of TNChattanoogaTennessee37403-
Local Institution - 0019NashvilleTennessee37203-
Local Institution - 0026BedfordTexas76022-
Local Institution - 0034DallasTexas75246-
Local Institution - 0037Fort WorthTexas76104-
Local Institution - 0040San AntonioTexas78217-
Local Institution - 0036TylerTexas75702-
Local Institution - 0025RichmondVirginia23229-
Local Institution - 0028RoanokeVirginia24014-
Local Institution - 0006MadisonWisconsin53705-

Find similar trials in Birmingham, AL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Uab Comprehensive Cancer Center· Birmingham, ALLocal Institution - 0004· Los Angeles, CALocal Institution - 0010· Aurora, COLocal Institution - 0027· Denver, COLocal Institution - 0020· New Haven, CTLocal Institution - 0039· Miami, FL

Related Studies