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

NCT03662659

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
  • Official Title: A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) Plus Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: CA224-060
  • SECONDARY ID: 2018-001069-18
  • NCT ID: NCT03662659

Conditions

  • Gastric Cancer
  • Cancer of the Stomach
  • Esophagogastric Junction

Interventions

DrugSynonymsArms
BMS-986213BMS-986213 + investigator's choice chemotherapy
NivolumabOpdivo, BMS-936558BMS-986213 + investigator's choice chemotherapy
XELOXBMS-986213 + investigator's choice chemotherapy
FOLFOXBMS-986213 + investigator's choice chemotherapy
SOXBMS-986213 + investigator's choice chemotherapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
BMS-986213 + investigator's choice chemotherapyExperimentalBMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
  • XELOX
  • FOLFOX
  • SOX
Nivolumab + investigator's choice chemotherapyExperimentalNivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
  • XELOX
  • FOLFOX
  • SOX

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

          -  Histologically- or cytologically-confirmed diagnosis of unresectable, locally
             advanced, or metastatic gastric cancer or GEJ adenocarcinoma

          -  No prior treatment with systemic treatment (including HER 2 inhibitors) given as
             primary therapy for unresectable, locally advanced, or metastatic GC or GEJ
             adenocarcinoma

          -  Tumor tissue must be provided for biomarker analyses

        Exclusion Criteria:

          -  Participants with HER2 positive status

          -  Participants with known untreated central nervous system (CNS) metastases

          -  Uncontrolled or significant cardiovascular disease

        Other protocol defined inclusion/exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to 22 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of Adverse Events (AEs)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of Serious Adverse Events (SAEs)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of AEs leading to discontinuation
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of death
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Progression Free Survival (PFS)
Time Frame:Up to 5 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

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