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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

NCT03704077

Description:

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.

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

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination With Various Standard-of-Care Therapeutic Regimens, in Participants With Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: CA224-061
  • SECONDARY ID: 2018-001070-20
  • NCT ID: NCT03704077

Conditions

  • Gastric Cancer
  • Cancer of the Stomach
  • Stomach Cancer
  • Gastroesophageal Junction

Interventions

DrugSynonymsArms
Relatlimab + NivolumabBMS-986213Cohort A: relatlimab + nivolumab + paclitaxel
NivolumabOpdivoCohort A: relatlimab + nivolumab + paclitaxel
PaclitaxelTaxol, OnxalCohort A: relatlimab + nivolumab + paclitaxel
RamucirumabCyramzaCohort A: ramucirumab + paclitaxel

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cohort A: relatlimab + nivolumab + paclitaxelExperimental
  • Relatlimab + Nivolumab
  • Nivolumab
  • Paclitaxel
Cohort A: nivolumab + paclitaxelExperimental
  • Nivolumab
  • Paclitaxel
Cohort A: ramucirumab + paclitaxelActive ComparatorStandard-of-care
  • Paclitaxel
  • Ramucirumab
Cohort B: relatlimab + nivolumabExperimental
  • Relatlimab + Nivolumab
  • Nivolumab
Cohort B: nivolumabActive ComparatorStandard-of-care
  • Nivolumab
Cohort C: relatlimab + nivolumabExperimental
  • Relatlimab + Nivolumab
  • Nivolumab

Eligibility Criteria

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

        Inclusion Criteria:

          -  Histologically or cytologically confirmed locally advanced or recurrent or metastatic
             GC or GEJ adenocarcinoma that is considered incurable by local therapies such as
             radiation or surgery

          -  Evidence of progressive disease (PD) on at least one prior platinum- and
             fluoropyrimidine-containing chemotherapy regimen

          -  Available tumor tissue for biomarker analysis

        Exclusion Criteria:

          -  Must not have squamous cell or undifferentiated GC or GEJ

          -  Untreated known 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:Overall response rate (ORR)
Time Frame:Approximately 31 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of adverse events (AEs)
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Incidence of serious adverse events (SAEs)
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Incidence of AEs leading to discontinuation
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Incidence of deaths
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:ORR
Time Frame:Approximately 5 years
Safety Issue:
Description:Cohort A1
Measure:Duration of response (DOR)
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Progression free survival (PFS)
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:Approximately 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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