Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03662659
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Cancer of the Stomach Esophagogastric Junction Biological: BMS-986213 Biological: Nivolumab Drug: XELOX Drug: FOLFOX Drug: SOX Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : December 27, 2020
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: BMS-986213 + investigator's choice chemotherapy
BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
Biological: BMS-986213
Relatlimab + Nivolumab specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: XELOX
Oxaliplatin + capecitabine

Drug: FOLFOX
Oxaliplatin + leucovorin + fluorouracil

Drug: SOX
Oxaliplatin + tegafur/gimeracil/oteracil potassium

Experimental: Nivolumab + investigator's choice chemotherapy
Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: XELOX
Oxaliplatin + capecitabine

Drug: FOLFOX
Oxaliplatin + leucovorin + fluorouracil

Drug: SOX
Oxaliplatin + tegafur/gimeracil/oteracil potassium




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 22 months ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  3. Incidence of AEs leading to discontinuation [ Time Frame: Up to 5 years ]
  4. Incidence of death [ Time Frame: Up to 5 years ]
  5. Incidence of laboratory abnormalities [ Time Frame: Up to 5 years ]
  6. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
  7. Overall survival (OS) [ Time Frame: Up to 5 years ]
  8. Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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, 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662659


Contacts
Layout table for location contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Hide Study Locations
Locations
Layout table for location information
United States, California
University Of California San Francisco-Fresno Recruiting
Clovis, California, United States, 93611
Contact: Uzair Chaudhary, Site 0049         
City Of Hope National Medical Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Joseph Chao, Site 0064    626-218-3494      
Local Institution Not yet recruiting
La Jolla, California, United States, 92037
Contact: Site 0053         
Usc/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Syma Iqbal, Site 0040         
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Zev Wainberg, Site 0077         
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Contact: Syma Iqbal, Site 0094         
Uc Irvine Medical Center Recruiting
Orange, California, United States, 92868-3201
Contact: Farshid Dayyani, Site 0041         
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Sarah Davis, Site 0056         
United States, Connecticut
Yale University School Of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Jill Lacy, Site 0062         
United States, Maryland
Local Institution Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Site 0103         
United States, Massachusetts
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Site 0101         
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Site 0102         
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Martin Gutierrez, Site 0050         
United States, New York
Local Institution Not yet recruiting
New York, New York, United States, 10065
Contact: Site 0051         
United States, North Dakota
Local Institution Not yet recruiting
Bismarck, North Dakota, United States, 58501-4400
Contact: Site 0065         
Local Institution Not yet recruiting
Fargo, North Dakota, United States, 58122
Contact: Site 0068         
United States, South Dakota
Local Institution Not yet recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Site 0066         
United States, Texas
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: David Wang, Site 0054         
Local Institution Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Site 0100         
Local Institution Not yet recruiting
Houston, Texas, United States, 77030-4009
Contact: Site 0104         
United States, Virginia
Local Institution Not yet recruiting
Richmond, Virginia, United States, 23226
Contact: Site 0096         
United States, Washington
Local Institution Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Site 0052         
Argentina
Fundacion Favaloro Recruiting
Capital Federal, Buenos Aires, Argentina, 1264
Contact: Guillermo Mendez, Site 0009    +5491164672482      
Hospital Britanico De Buenos Aires Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1280
Contact: Luciana Bellaquero, Site 0010    +5443041081      
Instituto Medico Especialazado Alexander Fleming Recruiting
Caba, Argentina, 1426
Contact: Juan Manuel Oconnor, Site 0078    +549113149395      
Centro Medico San Roque Recruiting
Tucuman, Argentina, 4000
Contact: Juan Zarba, Site 0011    +543844306987      
Australia, New South Wales
Local Institution Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 0027         
Australia, Queensland
Local Institution Recruiting
Herston, Queensland, Australia, 4029
Contact: Site 0007         
Australia, Victoria
Local Institution Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Site 0003         
Local Institution Recruiting
Malvern, Victoria, Australia, 3144
Contact: Site 0029         
Australia
Local Institution Recruiting
Bedford Park, Australia, 5024
Contact: Site 0028         
St John of God Murdoch Hospital Recruiting
Murdoch, Australia, 6150
Contact: Kynan Feeney, Site 0005    +618942886370      
Belgium
Local Institution Recruiting
Bruxelles, Belgium, 1200
Contact: Site 0091         
Local Institution Recruiting
Leuven, Belgium, 3000
Contact: Site 0092         
Canada, Alberta
Local Institution Withdrawn
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Local Institution Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Site 0024         
Canada, Nova Scotia
Local Institution Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Site 0063         
Canada, Ontario
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Site 0042         
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Site 0070         
Canada, Quebec
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Site 0097         
Local Institution Withdrawn
Montreal, Quebec, Canada, H4J 1C5
Local Institution Withdrawn
Sherbrooke, Quebec, Canada, J1H 5N4
Local Institution Recruiting
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Contact: Site 0055         
Canada
Local Institution Recruiting
Quebec, Canada, G1R 2J6
Contact: Site 0095         
Chile
Local Institution Recruiting
Rancagua, L.g.bernardoohiggins, Chile
Contact: Site 0002         
Local Institution Not yet recruiting
Santiago, Metropolitana, Chile
Contact: Site 0080         
Oncocentro Apys Recruiting
Vina del Mar, Valparaiso, Chile, 2520598
Contact: Alejandro Andres Acevedo Gaete, Site 0001    +56322323781      
Local Institution Not yet recruiting
Santiago, Chile
Contact: Site 0079         
Czechia
Klinika komplexni onkologicke pece Recruiting
Brno, Czechia, 656 53
Contact: Radim Nemecek, Site 0031    +420543136808      
Onkologicka klinika Recruiting
Olomouc, Czechia, 779 00
Contact: Bohuslav Melichar, Site 0030    +420588444295 000 000 000      
France
Local Institution Recruiting
Avignon Cedex 9, France, 84918
Contact: Site 0047         
Local Institution Recruiting
Besancon Cedex, France, 25030
Contact: Site 0073         
Local Institution Recruiting
Dijon, France, 21000
Contact: Site 0045         
Local Institution Not yet recruiting
Lille, France, 59000
Contact: Site 0074         
Local Institution Not yet recruiting
Montpellier, France, 34090
Contact: Site 0071         
Local Institution Recruiting
Paris, France, 75010
Contact: Site 0043         
Local Institution Recruiting
Paris, France, 75012
Contact: Site 0072         
Local Institution Not yet recruiting
Rouen Cedex, France, 76031
Contact: Site 0046         
Germany
Local Institution Recruiting
Cologne, Germany, 50937
Contact: Site 0083         
Universitatsklinikum Carl Gustav Carus Dresden Recruiting
Dresden, Germany, 01307
Contact: Gunnar Folprecht, Site 0082         
Klinik Essen-Mitte Recruiting
Essen, Germany, 45136
Contact: Michael Stahl, Site 0017    +4920117424523      
Local Institution Not yet recruiting
Essen, Germany, 45147
Contact: Site 0081         
Krankenhaus Nordwest Recruiting
Frankfurt, Germany, 60488
Contact: Salah-Eddin Al-Batran, Site 0014    +496976014558      
Facharztzentrum Eppendorf Recruiting
Hamburg, Germany, 20249
Contact: Susanna Hegewisch-Becker, Site 0018    +4940360352242      
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Arndt Vogel, Site 0012    +495115326779      
Nationales Centrum Fur Tumorerkrankungen (Nct) Recruiting
Heidelberg, Germany, 69120
Contact: Georg Martin Haag, Site 0013    +496221566857      
Universitaetsklinikum Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Ralf Hofheinz, Site 0015    +496213833258      
Universitaets-Klinikum Marburg Recruiting
Marburg, Germany, 35043
Contact: Jorge Riera-Knorrenschild, Site 0016    +4964215861819      
Norway
Local Institution Recruiting
Bergen, Norway, 5021
Contact: Site 0088         
Local Institution Recruiting
Oslo, Norway, 0450
Contact: Site 0086         
Local Institution Recruiting
Trondheim, Norway, 7030
Contact: Site 0087         
Poland
Local Institution Not yet recruiting
Warszawa, Poland, 02-034
Contact: Site 0093         
Puerto Rico
Local Institution Recruiting
San Juan, Puerto Rico, 00927
Contact: Site 0067         
Singapore
Local Institution Not yet recruiting
Singapore, Singapore, 119228
Contact: Site 0039         
Local Institution Recruiting
Singapore, Singapore, 169610
Contact: Site 0038         
Spain
Local Institution Not yet recruiting
Badajoz, Spain, 06080
Contact: Site 0099         
Local Institution Not yet recruiting
Barcelona, Spain, 08035
Contact: Site 0098         
Local Institution Recruiting
Barcelona, Spain, 08036
Contact: Site 0061         
Local Institution Recruiting
Bilbao, Spain, 48013
Contact: Site 0059         
Local Institution Recruiting
Madrid, Spain, 28007
Contact: Site 0057         
Local Institution Recruiting
Madrid, Spain, 28046
Contact: Site 0058         
Hospital Univ. Miguel Servet Recruiting
Zaragoza, Spain, 50009
Contact: Roberto Antonio Pazo Cid, Site 0060    +34976765500      
United Kingdom
Local Institution Recruiting
London, Greater London, United Kingdom, SE1 9RY
Contact: Site 0034         
Local Institution Not yet recruiting
London, Greater London, United Kingdom, SW3 6JJ
Contact: Site 0085         
Local Institution Not yet recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: Site 0075         
Local Institution Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Contact: Site 0035         
Local Institution Not yet recruiting
Coventry, WEST Midlands, United Kingdom, CV2 2DX
Contact: Site 0032         
Local Institution Recruiting
Lancaster, United Kingdom, LA1 4RP
Contact: Site 0036         
Local Institution Recruiting
Northwood, United Kingdom, HA6 2RN
Contact: Site 0069         
Local Institution Not yet recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Site 0033         
Local Institution Not yet recruiting
Surrey, United Kingdom, SM2 5PT
Contact: Site 0076         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03662659     History of Changes
Other Study ID Numbers: CA224-060
2018-001069-18 ( EudraCT Number )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents