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

Phase 2

Withdrawn

• Conditions: Cancer of the Stomach; Stomach Cancer; Gastric Cancer; Gastroesophageal Junction
• Interventions: Biological: Relatlimab + Nivolumab; Biological: Nivolumab; Drug: Ramucirumab; Drug: Paclitaxel

• Registration Number: NCT03704077
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-12
• Study Start: 2019-10-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-17
• Last Update Posted: 2020-05-19
• Primary Completion: 2022-02-27
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort C: relatlimab + nivolumab	Nivolumab	-
Cohort A: relatlimab + nivolumab + paclitaxel	Nivolumab	-
Cohort A: ramucirumab + paclitaxel	Ramucirumab	Standard-of-care
Cohort B: relatlimab + nivolumab	Nivolumab	-
Cohort B: nivolumab	Nivolumab	Standard-of-care
Cohort A: relatlimab + nivolumab + paclitaxel	Relatlimab + Nivolumab	-
Cohort B: relatlimab + nivolumab	Relatlimab + Nivolumab	-
Cohort A: nivolumab + paclitaxel	Nivolumab	-
Cohort C: relatlimab + nivolumab	Relatlimab + Nivolumab	-
Cohort A: nivolumab + paclitaxel	Paclitaxel	-
Cohort A: relatlimab + nivolumab + paclitaxel	Paclitaxel	-
Cohort A: ramucirumab + paclitaxel	Paclitaxel	Standard-of-care

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	Approximately 31 months

Secondary Outcome Measures

Name	Time	Method
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	Cohort A1
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

Trial Locations

Locations (1)

Local Institution; 🇪🇸 Valencia, Spain