NCT03662659CompletedPhase 2
An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 5 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 274 (actual)
- First submitted
- 6 Sept 2018
- Start date
- 16 Oct 2018
- Primary completion date
- 27 Aug 2020
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03662659
- EudraCT number
- 2018-001069-18
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 274
- From 16 Oct 2018 to the primary completion date, 27 Aug 2020
- 79 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled or significant cardiovascular disease
- Other protocol defined inclusion/exclusion criteria could apply
Other
- Participants with HER2 positive status
- Participants with known untreated central nervous system (CNS) metastases
Who the study is looking for
- 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
Criteria the registry did not label
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (79)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0009 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Local Institution - 0078 Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Local Institution - 0010 Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Unknown status |
| Local Institution - 0011 Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Local Institution - 0090 Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Local Institution - 0089 Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Malvern | Australia | Unknown status |
| Local Institution - 0005 Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Local Institution - 0008 Coordinator of this site? Confirm its status | Shepparton | Australia | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Local Institution - 0091 Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Local Institution - 0092 Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Local Institution - 0063 Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Local Institution - 0024 Coordinator of this site? Confirm its status | Kelowna | Canada | Unknown status |
| Local Institution - 0095 Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Local Institution - 0070 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Local Institution - 0055 Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Rancagua | Chile | Unknown status |
| Local Institution - 0080 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Local Institution - 0031 Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Local Institution - 0030 Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Local Institution - 0083 Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Local Institution - 0082 Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Local Institution - 0081 Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Local Institution - 0014 Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Local Institution - 0018 Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Local Institution - 0013 Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Local Institution - 0015 Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Marburg | Germany | Unknown status |
| Local Institution - 0099 Coordinator of this site? Confirm its status | Badajoz | Spain | Unknown status |
| Local Institution - 0061 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Local Institution - 0098 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Local Institution - 0059 Coordinator of this site? Confirm its status | Bilbao | Spain | Unknown status |
| Local Institution - 0058 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 0057 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 0060 Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Local Institution - 0047 Coordinator of this site? Confirm its status | Avignon | France | Unknown status |
| Local Institution - 0073 Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Local Institution - 0045 Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Local Institution - 0071 Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Local Institution - 0043 Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Local Institution - 0072 Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Local Institution - 0046 Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Coventry | United Kingdom | Unknown status |
| Local Institution - 0036 Coordinator of this site? Confirm its status | Lancaster | United Kingdom | Unknown status |
| Local Institution - 0034 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0075 Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Local Institution - 0069 Coordinator of this site? Confirm its status | Northwood | United Kingdom | Unknown status |
| Local Institution - 0035 Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| IRCCS Istituto Nazionale Tumori Milano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Local Institution - 0020 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Local Institution - 0021 Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Local Institution - 0088 Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Local Institution - 0086 Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Local Institution - 0087 Coordinator of this site? Confirm its status | Trondheim | Norway | Unknown status |
| Local Institution - 0093 Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Local Institution - 0067 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Local Institution - 0038 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0056 Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Local Institution - 0049 Coordinator of this site? Confirm its status | Clovis | United States | Unknown status |
| Local Institution - 0054 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Local Institution - 0064 Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Local Institution - 0050 Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Scripps Clinic Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Local Institution - 0040 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Local Institution - 0062 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Hoag Memorial Hospital Presbyterian Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Local Institution - 0041 Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Virginia Cancer Institute Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.