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

NCT03662659 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CA224-0602018-001069-18
• Study Type: interventional
• Target: 274
• Locations: 16 countries
• Sites: 72

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.

Conditions

Gastric Cancer; Cancer of the Stomach; Esophagogastric Junction

Outcome Measures

Primary Outcomes (2)

• BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants

  The number of LAG-3 Positive (\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \[per RECISIT 1.1\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions

  Up to 25 months

• BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended Collection

  The number of LAG-3 Positive (\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \[per RECISIT 1.1\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.

  From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

• Duration of Response (DOR)

  From the date of first dose to the date of the first disease progression or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

• Overall Survival (OS)

  From the date of randomization to the date of death due to any cause (Up to 63 months)

• Progression-Free Survival (PFS)

  From the date of randomization to the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From first dose to 30 days post last dose (Up to 60 months)

Study Arms (2)

BMS-986213 + investigator's choice chemotherapy

EXPERIMENTAL

BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX

Biological: BMS-986213; Biological: Nivolumab; Drug: XELOX; Drug: FOLFOX; Drug: SOX

Nivolumab + investigator's choice chemotherapy

EXPERIMENTAL

Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX

Biological: Nivolumab; Drug: XELOX; Drug: FOLFOX; Drug: SOX

Interventions

BMS-986213 BIOLOGICAL

Relatlimab + Nivolumab specified dose on specified days

BMS-986213 + investigator's choice chemotherapy

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-936558

BMS-986213 + investigator's choice chemotherapy; Nivolumab + investigator's choice chemotherapy

XELOX DRUG

Oxaliplatin + capecitabine

BMS-986213 + investigator's choice chemotherapy; Nivolumab + investigator's choice chemotherapy

FOLFOX DRUG

Oxaliplatin + leucovorin + fluorouracil

BMS-986213 + investigator's choice chemotherapy; Nivolumab + investigator's choice chemotherapy

SOX DRUG

Oxaliplatin + tegafur/gimeracil/oteracil potassium

BMS-986213 + investigator's choice chemotherapy; Nivolumab + investigator's choice chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants with HER2 positive status
• Participants with known untreated central nervous system (CNS) metastases
• Uncontrolled or significant cardiovascular disease

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (79)

Local Institution - 0049

Clovis, California, 93611, United States

Location

Local Institution - 0064

Duarte, California, 91010-3012, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

Local Institution - 0040

Los Angeles, California, 90033, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Local Institution - 0041

Orange, California, 92868, United States

Location

Local Institution - 0077

Santa Monica, California, 90404, United States

Location

Local Institution - 0056

Aurora, Colorado, 80045, United States

Location

Local Institution - 0062

New Haven, Connecticut, 06520, United States

Location

Local Institution - 0050

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0054

Dallas, Texas, 75216, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

Local Institution - 0052

Seattle, Washington, 98109, United States

Location

Local Institution - 0010

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280, Argentina

Location

Local Institution - 0009

Buenos Aires, Buenos Aires F.D., C1093AAS, Argentina

Location

Local Institution - 0011

San Miguel de Tucumán, Tucumán Province, T4000IAK, Argentina

Location

Local Institution - 0078

CABA, 1426, Argentina

Location

Local Institution - 0027

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0007

Herston, Queensland, 4029, Australia

Location

Local Institution - 0003

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0029

Malvern, Victoria, 3144, Australia

Location

Local Institution - 0008

Shepparton, Victoria, 3630, Australia

Location

Local Institution - 0005

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0028

Bedford Park, 5024, Australia

Location

Local Institution - 0090

Graz, 8036, Austria

Location

Local Institution - 0089

Vienna, 1090, Austria

Location

Local Institution - 0091

Brussels, 1200, Belgium

Location

Local Institution - 0092

Leuven, 3000, Belgium

Location

Local Institution - 0024

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Local Institution - 0063

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Local Institution - 0070

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0095

Québec, Quebec, G1R 2J6, Canada

Location

Local Institution - 0055

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Local Institution - 0002

Rancagua, L.g.bernardoohiggins, 0, Chile

Location

Local Institution - 0001

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Local Institution - 0080

Santiago, Santiago Metropolitan, Chile

Location

Local Institution - 0079

Santiago, 0, Chile

Location

Local Institution - 0031

Brno, 656 53, Czechia

Location

Local Institution - 0030

Olomouc, 779 00, Czechia

Location

Local Institution - 0047

Avignon, 84918, France

Location

Local Institution - 0073

Besançon, 25030, France

Location

Local Institution - 0045

Dijon, 21000, France

Location

Local Institution - 0071

Montpellier, 34090, France

Location

Local Institution - 0043

Paris, 75010, France

Location

Local Institution - 0072

Paris, 75012, France

Location

Local Institution - 0046

Rouen, 76031, France

Location

Local Institution - 0083

Cologne, 50937, Germany

Location

Local Institution - 0082

Dresden, 01307, Germany

Location

Local Institution - 0017

Essen, 45136, Germany

Location

Local Institution - 0081

Essen, 45147, Germany

Location

Local Institution - 0014

Frankfurt, 60488, Germany

Location

Local Institution - 0018

Hamburg, 20249, Germany

Location

Local Institution - 0012

Hanover, 30625, Germany

Location

Local Institution - 0013

Heidelberg, 69120, Germany

Location

Local Institution - 0015

Mannheim, 68167, Germany

Location

Local Institution - 0016

Marburg, 35043, Germany

Location

Local Institution - 0020

Milan, 20132, Italy

Location

IRCCS Istituto Nazionale Tumori Milano

Milan, 20133, Italy

Location

Local Institution - 0021

Roma, 00168, Italy

Location

Local Institution - 0088

Bergen, 5021, Norway

Location

Local Institution - 0086

Oslo, 0450, Norway

Location

Local Institution - 0087

Trondheim, 7030, Norway

Location

Local Institution - 0093

Warsaw, 02-034, Poland

Location

Local Institution - 0067

San Juan, 00927, Puerto Rico

Location

Local Institution - 0038

Singapore, 168583, Singapore

Location

Local Institution - 0058

Madrid, M, 28046, Spain

Location

Local Institution - 0099

Badajoz, 06080, Spain

Location

Local Institution - 0098

Barcelona, 08035, Spain

Location

Local Institution - 0061

Barcelona, 08036, Spain

Location

Local Institution - 0059

Bilbao, 48013, Spain

Location

Local Institution - 0057

Madrid, 28007, Spain

Location

Local Institution - 0060

Zaragoza, 50009, Spain

Location

Local Institution - 0075

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

Local Institution - 0035

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Local Institution - 0032

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

Local Institution - 0036

Lancaster, LA1 4RP, United Kingdom

Location

Local Institution - 0034

London, SE1 9RT, United Kingdom

Location

Local Institution - 0069

Northwood, HA6 2RN, United Kingdom

Location

Local Institution - 0033

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• Hegewisch-Becker S, Mendez G, Chao J, Nemecek R, Feeney K, Van Cutsem E, Al-Batran SE, Mansoor W, Maisey N, Pazo Cid R, Burge M, Perez-Callejo D, Hipkin RW, Mukherjee S, Lei M, Tang H, Suryawanshi S, Kelly RJ, Tebbutt NC. First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study. J Clin Oncol. 2024 Jun 10;42(17):2080-2093. doi: 10.1200/JCO.23.01636. Epub 2024 May 9.

  PMID: 38723227 DERIVED

• Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

  PMID: 35623069 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Nivolumab; XELOX; Folfox protocol

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 7, 2018
• Study Start: October 16, 2018
• Primary Completion: August 27, 2020
• Study Completion: January 18, 2024
• Last Updated: February 5, 2025
• Results First Posted: May 9, 2022

Record last verified: 2025-01

Locations

DE (10); CA (5); AR (4); AU (2); ES (7); PL (1); IT (3); FR (7); BE (2); SG (1); US (13); CL (4); PR (1); NO (3); GB (7); CZ (2)