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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 2

Conditions: Gastric Cancer; Cancer of the Stomach; Stomach Cancer; Gastroesophageal Junction

Treatments: Biological: Relatlimab + Nivolumab; Drug: Paclitaxel; Drug: Ramucirumab; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03704077

2018-001070-20 (EudraCT Number)

CA224-061

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 6 patient groups

Cohort A: relatlimab + nivolumab + paclitaxel

Experimental group

Treatment:

Biological: Nivolumab

Drug: Paclitaxel

Biological: Relatlimab + Nivolumab

Cohort A: nivolumab + paclitaxel

Experimental group

Treatment:

Biological: Nivolumab

Drug: Paclitaxel

Cohort A: ramucirumab + paclitaxel

Active Comparator group

Description:

Standard-of-care

Treatment:

Drug: Ramucirumab

Drug: Paclitaxel

Cohort B: relatlimab + nivolumab

Experimental group

Treatment:

Biological: Nivolumab

Biological: Relatlimab + Nivolumab

Cohort B: nivolumab

Active Comparator group

Description:

Standard-of-care

Treatment:

Biological: Nivolumab

Cohort C: relatlimab + nivolumab

Experimental group

Treatment:

Biological: Nivolumab

Biological: Relatlimab + Nivolumab