An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03704077
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Relatlimab + Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Paclitaxel — DRUG
    Specified dose on specified days
  • Ramucirumab — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.

Key Dates

Start date
Oct 31, 2019
Status verified
May 2020
Primary completion
Feb 27, 2022
Completion
Sep 30, 2024

Study Design

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

Arms

  • Experimental: Cohort A: relatlimab + nivolumab + paclitaxel
  • Experimental: Cohort A: nivolumab + paclitaxel
  • Active Comparator: Cohort A: ramucirumab + paclitaxel
    Standard-of-care
  • Experimental: Cohort B: relatlimab + nivolumab
  • Active Comparator: Cohort B: nivolumab
    Standard-of-care
  • Experimental: Cohort C: relatlimab + nivolumab

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Approximately 31 months ]

Locations (20)

FacilityCityStateZIPSite coordinators
Local InstitutionDaphneAlabama36526-
Local InstitutionBakersfieldCalifornia93309-
Local InstitutionFullertonCalifornia92835-
Local InstitutionLos AngelesCalifornia90095-
Local InstitutionRedondo BeachCalifornia90277-
Local InstitutionSanta BarbaraCalifornia93105-
Local InstitutionAuroraColorado80045-
Local InstitutionLakewoodColorado80228-
Local InstitutionMiamiFlorida33176-
Local InstitutionTampaFlorida33612-
Local InstitutionMariettaGeorgia30060-
Local InstitutionBostonMassachusetts02215-
Local InstitutionSt LouisMissouri63110-
Local InstitutionNew BrunswickNew Jersey08009-
Local InstitutionChapel HillNorth Carolina27599-
Local InstitutionCharlotteNorth Carolina28204-
Local InstitutionFargoNorth Dakota58102-
Local InstitutionAllentownPennsylvania18103-
Local InstitutionSioux FallsSouth Dakota57104-
Local InstitutionVancouverWashington98684-

Find similar trials in Daphne, AL

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
Local Institution· Daphne, ALLocal Institution· Bakersfield, CALocal Institution· Fullerton, CALocal Institution· Los Angeles, CALocal Institution· Redondo Beach, CALocal Institution· Santa Barbara, CA

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