Phase 2
N=190
A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer
Advanced Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02935634 ↗Enrolled (actual)
190
Serious AEs
69.2%
Results posted
Jun 2023
Primary outcome: Primary: Objective Response Rate (ORR) by Investigator — 4.3; 5.0; 13.2; 0 Percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Biological); Ipilimumab (Biological); Relatlimab (Biological); BMS-986205 (Biological); Rucaparib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) by Investigator |
4.3; 5.0; 13.2; 0; 0; 16.7 | — |
| PRIMARY Median Duration of Response (DOR) |
156.0; NA; NA; NA; 14.71; 16.86 | — |
| PRIMARY Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks |
NA; NA; 0.240; NA; NA; NA | — |
| SECONDARY Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death |
23; 20; 38; 7; 8; 6 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests |
4; 4; 6; 1; 1; 1 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in Specific Liver Tests |
6; 6; 5; 1; 2; 1 | — |
Summary
The purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of Nivolumab in combination with Ipilimumab or other treatment therapies in participants with advanced gastric cancer.
Eligibility Criteria
Inclusion Criteria
- Inoperable, advanced or metastatic esophageal cancer (EC), gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed predominant adenocarcinoma and/or squamous carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- At least 1 lesion with measurable disease
Exclusion Criteria
- HER2-positive tumor and previously untreated with trastuzumab
- Suspected, known or progressive central nervous system metastases
- Other active malignancy requiring concurrent intervention
- Active, known or suspected autoimmune disease
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02935634). 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.