Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02872116
Phase
PHASE3
Status
Completed

Conditions

  • Esophageal Adenocarcinoma
  • Gastric Cancer
  • Gastroesophageal Junction Cancer

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Specified dose on specified days
  • Ipilimumab — DRUG
    Specified dose on specified days
  • Oxaliplatin — DRUG
    Specified dose on specified days
  • Capecitabine — DRUG
    Specified dose on specified days
  • Leucovorin — DRUG
    Specified dose on specified days
  • Fluorouracil — DRUG
    Specified dose on specified days

Study Details

The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.

Key Dates

Start date
Oct 12, 2016
Status verified
Jul 2025
Primary completion
May 27, 2020
Completion
Jun 6, 2024

Study Design

Enrollment
2,031 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + Ipilimumab
    Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy Enrollment is closed for this arm
  • Active Comparator: XELOX (Oxaliplatin + Capecitabine)
  • Active Comparator: FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
  • Experimental: Nivolumab + XELOX
  • Experimental: Nivolumab + FOLFOX

Primary Outcome Measure

Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 [ Time Frame: From the date of randomization up to the date of death, up to approximately 17 months ]

Locations (27)

FacilityCityStateZIPSite coordinators
Local Institution - 0005Los AngelesCalifornia90033-
Local Institution - 0001San FranciscoCalifornia94115-1932-
Local Institution - 0066AuroraColorado80045-
Local Institution - 0151DenverColorado80218-
Local Institution - 0136Washington D.C.District of Columbia20007-
Florida Cancer Specialists S.Fort MyersFlorida33901-
Local Institution - 0147MiamiFlorida33176-
Florida Cancer SpecialistsSt. PetersburgFlorida33705-
Local Institution - 0179MariettaGeorgia30060-
Local Institution - 0219Arlington HeightsIllinois60005-
Local Institution - 0120ChicagoIllinois60611-
Local Institution - 0021BaltimoreMaryland21224-
Local Institution - 0002BostonMassachusetts02215-
Local Institution - 0135BostonMassachusetts02215-
Local Institution - 0003New YorkNew York10065-
Local Institution - 0138ClevelandOhio44106-
Local Institution - 0186ClevelandOhio44195-
Local Institution - 0146EugeneOregon97401-
Lehigh Valley Health NetworkAllentownPennsylvania18105-
Local Institution - 0065PittsburghPennsylvania15212-
Local Institution - 0104NashvilleTennessee37203-
Local Institution - 0140BedfordTexas76022-
Local Institution - 0143DallasTexas75230-
Local Institution - 0213DallasTexas75246-
Local Institution - 0004HoustonTexas77030-
Texas Oncology-Plano EastPlanoTexas75075-7787-
Local Institution - 0150Newport NewsVirginia23606-

Find similar trials in Los Angeles, CA

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
Local Institution - 0005· Los Angeles, CALocal Institution - 0001· San Francisco, CALocal Institution - 0066· Aurora, COLocal Institution - 0151· Denver, COLocal Institution - 0136· Washington D.C., DCFlorida Cancer Specialists S.· Fort Myers, FL

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