An Investigational Immuno-therapy Study to Compare Relatlimab in Combination with Nivolumab with Various Standard-of-Care Therapies in Patients with Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
- Conditions
- Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) AdenocarcinomaMedDRA version: 20.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10056267 Term: Gastroesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-001070-20-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 2180
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1526
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 654
- Squamous cell or undifferentiated GC or GEJ
- Untreated known central nervous system (CNS) metastases
- Prior treatment with relatlimab or any other LAG-3 targeted agents
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method