Phase 2
Completed N=274
An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
Gastric Cancer · Esophagogastric Junction
Source: ClinicalTrials.gov NCT03662659 ↗
Enrolled (actual)
274
Serious AEs
77.5%
Results posted
May 2022
Primary outcomePrimary: BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants — 48.5; 61.2 Percentage of Participants
Summary
The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants |
48.5; 61.2 | — |
| PRIMARY BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended Collection |
27.8; 43.9 | — |
| SECONDARY Objective Response Rate (ORR) |
26.8; 36.8; 27.5; 41.9; 53.6; 54.1 | — |
| SECONDARY Duration of Response (DOR) |
7.72; 10.78; 5.44; 5.55; 5.68; 6.93 | — |
| SECONDARY Overall Survival (OS) |
14.19; 14.98; 9.72; 15.51; 12.65; 15.15 | — |
| SECONDARY Progression-Free Survival (PFS) |
7.26; 10.84; 6.80; 10.45; 7.13; 10.45 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
135; 135; 99; 87; 76; 56 | — |
| SECONDARY Number of Participants Who Died |
122; 118 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in Specific Liver Tests |
31; 14; 12; 5; 4; 1 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests |
39; 43; 35; 33; 24; 20 | — |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
- No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma
- Tumor tissue must be provided for biomarker analyses
Exclusion Criteria
- Participants with HER2 positive status
- Participants with known untreated central nervous system (CNS) metastases
- Uncontrolled or significant cardiovascular disease
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03662659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.