An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

Part of paid clinical trials in Clovis, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03662659
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • BMS-986213 — BIOLOGICAL
    Relatlimab + Nivolumab specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • XELOX — DRUG
    Oxaliplatin + capecitabine
  • FOLFOX — DRUG
    Oxaliplatin + leucovorin + fluorouracil
  • SOX — DRUG
    Oxaliplatin + tegafur/gimeracil/oteracil potassium

Study Details

The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.

Key Dates

Start date
Oct 16, 2018
Status verified
Jan 2025
Primary completion
Aug 27, 2020
Completion
Jan 18, 2024

Study Design

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

Arms

  • Experimental: BMS-986213 + investigator's choice chemotherapy
    BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
  • Experimental: Nivolumab + investigator's choice chemotherapy
    Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX

Primary Outcome Measure

BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants [ Time Frame: Up to 25 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
Local Institution - 0049ClovisCalifornia93611-
Local Institution - 0064DuarteCalifornia91010-3012-
Scripps ClinicLa JollaCalifornia92037-
Local Institution - 0040Los AngelesCalifornia90033-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-
Local Institution - 0041OrangeCalifornia92868-
Local Institution - 0077Santa MonicaCalifornia90404-
Local Institution - 0056AuroraColorado80045-
Local Institution - 0062New HavenConnecticut06520-
Local Institution - 0050HackensackNew Jersey07601-
Local Institution - 0054DallasTexas75216-
Virginia Cancer InstituteRichmondVirginia23230-
Local Institution - 0052SeattleWashington98109-

Find similar trials in Clovis, CA

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
Local Institution - 0049· Clovis, CALocal Institution - 0064· Duarte, CAScripps Clinic· La Jolla, CALocal Institution - 0040· Los Angeles, CAHoag Memorial Hospital Presbyterian· Newport Beach, CALocal Institution - 0041· Orange, CA

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