NCT03704077
Withdrawn
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Relatlimab + Nivolumab
- Conditions
- Gastric Cancer
- Sponsor
- Bristol-Myers Squibb
- Locations
- 1
- Primary Endpoint
- Overall response rate (ORR)
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Cohort A: relatlimab + nivolumab + paclitaxel
Intervention: Relatlimab + Nivolumab
Cohort A: relatlimab + nivolumab + paclitaxel
Intervention: Nivolumab
Cohort A: relatlimab + nivolumab + paclitaxel
Intervention: Paclitaxel
Cohort A: nivolumab + paclitaxel
Intervention: Nivolumab
Cohort A: nivolumab + paclitaxel
Intervention: Paclitaxel
Cohort A: ramucirumab + paclitaxel
Standard-of-care
Intervention: Paclitaxel
Cohort A: ramucirumab + paclitaxel
Standard-of-care
Intervention: Ramucirumab
Cohort B: relatlimab + nivolumab
Intervention: Relatlimab + Nivolumab
Cohort B: relatlimab + nivolumab
Intervention: Nivolumab
Cohort B: nivolumab
Standard-of-care
Intervention: Nivolumab
Cohort C: relatlimab + nivolumab
Intervention: Relatlimab + Nivolumab
Cohort C: relatlimab + nivolumab
Intervention: Nivolumab
Outcomes
Primary Outcomes
Overall response rate (ORR)
Time Frame: Approximately 31 months
Secondary Outcomes
- Incidence of AEs leading to discontinuation(Approximately 5 years)
- Incidence of laboratory abnormalities(Approximately 5 years)
- Progression free survival (PFS)(Approximately 5 years)
- ORR(Approximately 5 years)
- Duration of response (DOR)(Approximately 5 years)
- Overall survival (OS)(Approximately 5 years)
- Incidence of serious adverse events (SAEs)(Approximately 5 years)
- Incidence of adverse events (AEs)(Approximately 5 years)
- Incidence of deaths(Approximately 5 years)
Study Sites (1)
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