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.
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
Drug | Synonyms | Arms |
---|
Relatlimab + Nivolumab | BMS-986213 | Cohort A: relatlimab + nivolumab + paclitaxel |
Nivolumab | Opdivo | Cohort A: nivolumab + paclitaxel |
Paclitaxel | Taxol, Onxal | Cohort A: nivolumab + paclitaxel |
Ramucirumab | Cyramza | Cohort 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
Name | Type | Description | Interventions |
---|
Cohort A: relatlimab + nivolumab + paclitaxel | Experimental | | - Relatlimab + Nivolumab
- Nivolumab
- Paclitaxel
|
Cohort A: nivolumab + paclitaxel | Experimental | | |
Cohort A: ramucirumab + paclitaxel | Active Comparator | Standard-of-care | |
Cohort B: relatlimab + nivolumab | Experimental | | - Relatlimab + Nivolumab
- Nivolumab
|
Cohort B: nivolumab | Active Comparator | Standard-of-care | |
Cohort C: relatlimab + nivolumab | Experimental | | - 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: | Withdrawn |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
May 19, 2020