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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662659
• Other study ID #: CA224-060
• Secondary ID: 2018-001069-18
• Status: Completed
• Phase: Phase 2
• Start date: October 16, 2018
• Est. completion date: January 18, 2024

Study information

• Verified date: February 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: January 18, 2024
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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

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

Related Conditions & MeSH terms

• Cancer of the Stomach
• Esophagogastric Junction
• Gastric Cancer
• Stomach Neoplasms

Intervention

Biological:
• BMS-986213
Relatlimab + Nivolumab specified dose on specified days
• Nivolumab
Specified dose on specified days

Drug:
• XELOX
Oxaliplatin + capecitabine
• FOLFOX
Oxaliplatin + leucovorin + fluorouracil
• SOX
Oxaliplatin + tegafur/gimeracil/oteracil potassium

Locations

Country	Name	City	State
Argentina	Local Institution - 0009	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Local Institution - 0078	Caba
Argentina	Local Institution - 0010	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Local Institution - 0011	San Miguel de Tucumán	Tucumán
Australia	Local Institution - 0028	Bedford Park
Australia	Local Institution - 0003	Heidelberg	Victoria
Australia	Local Institution - 0007	Herston	Queensland
Australia	Local Institution - 0029	Malvern	Victoria
Australia	Local Institution - 0005	Murdoch	Western Australia
Australia	Local Institution - 0008	Shepparton	Victoria
Australia	Local Institution - 0027	Westmead	New South Wales
Austria	Local Institution - 0090	Graz
Austria	Local Institution - 0089	Wien
Belgium	Local Institution - 0091	Bruxelles
Belgium	Local Institution - 0092	Leuven
Canada	Local Institution - 0063	Halifax	Nova Scotia
Canada	Local Institution - 0024	Kelowna	British Columbia
Canada	Local Institution - 0095	Quebec
Canada	Local Institution - 0070	Toronto	Ontario
Canada	Local Institution - 0055	Trois-Rivieres	Quebec
Chile	Local Institution - 0002	Rancagua	L.g.bernardoohiggins
Chile	Local Institution - 0079	Santiago
Chile	Local Institution - 0080	Santiago	Metropolitana
Chile	Local Institution - 0001	Vina del Mar	Valparaiso
Czechia	Local Institution - 0031	Brno
Czechia	Local Institution - 0030	Olomouc
France	Local Institution - 0047	Avignon Cedex 9
France	Local Institution - 0073	Besancon Cedex
France	Local Institution - 0045	Dijon
France	Local Institution - 0071	Montpellier
France	Local Institution - 0043	Paris
France	Local Institution - 0072	Paris
France	Local Institution - 0046	Rouen Cedex
Germany	Local Institution - 0083	Cologne
Germany	Local Institution - 0082	Dresden
Germany	Local Institution - 0017	Essen
Germany	Local Institution - 0081	Essen
Germany	Local Institution - 0014	Frankfurt
Germany	Local Institution - 0018	Hamburg
Germany	Local Institution - 0012	Hannover
Germany	Local Institution - 0013	Heidelberg
Germany	Local Institution - 0015	Mannheim
Germany	Local Institution - 0016	Marburg
Italy	Local Institution - 0020	Milan
Italy	IRCCS Istituto Nazionale Tumori Milano	Milano
Italy	Local Institution - 0021	Roma
Norway	Local Institution - 0088	Bergen
Norway	Local Institution - 0086	Oslo
Norway	Local Institution - 0087	Trondheim
Poland	Local Institution - 0093	Warszawa
Puerto Rico	Local Institution - 0067	San Juan
Singapore	Local Institution - 0038	Singapore
Spain	Local Institution - 0099	Badajoz
Spain	Local Institution - 0061	Barcelona
Spain	Local Institution - 0098	Barcelona
Spain	Local Institution - 0059	Bilbao
Spain	Local Institution - 0057	Madrid
Spain	Local Institution - 0058	Madrid	M
Spain	Local Institution - 0060	Zaragoza
United Kingdom	Local Institution - 0032	Coventry	West Midlands
United Kingdom	Local Institution - 0036	Lancaster
United Kingdom	Local Institution - 0034	London
United Kingdom	Local Institution - 0075	Manchester	Greater Manchester
United Kingdom	Local Institution - 0069	Northwood
United Kingdom	Local Institution - 0035	Nottingham	Nottinghamshire
United Kingdom	Local Institution - 0033	Southampton
United States	Local Institution - 0056	Aurora	Colorado
United States	Local Institution - 0049	Clovis	California
United States	Local Institution - 0054	Dallas	Texas
United States	Local Institution - 0064	Duarte	California
United States	Local Institution - 0050	Hackensack	New Jersey
United States	Scripps Clinic	La Jolla	California
United States	Local Institution - 0040	Los Angeles	California
United States	Local Institution - 0062	New Haven	Connecticut
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Local Institution - 0041	Orange	California
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Local Institution - 0077	Santa Monica	California
United States	Local Institution - 0052	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Chile,  Czechia,  France,  Germany,  Italy,  Norway,  Poland,  Puerto Rico,  Singapore,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Objective Response Rate (ORR)	Objective response rate (ORR) based on Blinded Independent Central Review (BICR) and Investigator assessments is defined as the number of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized 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.	Up to 25 months
Secondary	Duration of Response (DOR)	Duration of Response (DOR) based on Blinded Independent Central Review (BICR) and investigator is defined as the time between the date of first documented response (complete response or partial response) and the date of the first disease progression, per RECIST 1.1, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.	Up to 25 months
Secondary	Overall Survival (OS)	Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.	Up to 25 months
Secondary	Progression-Free Survival (PFS)	Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) and Investigator is defined as the time between the date of randomization and the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. Participants who die without a reported prior progression (and die without start of subsequent therapy) will be considered to have progressed on the date of death.	Up to 25 months
Secondary	Number of Participants With Adverse Events (AEs)	Number of participants with any grade adverse events (AEs), serious adverse events (SAE), and adverse events leading to discontinuation using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 5.0) to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.	From first dose to 30 days post last dose (Up to 23 months)
Secondary	Number of Deaths	Number of deaths in each arm to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.	Up to 25 months
Secondary	Number of Participants With Laboratory Abnormalities in Specific Liver Tests	Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN; Total bilirubin > 2 x ULN; ALP > 1.5 x ULN; Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN; Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN; Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN; Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN	From first dose to up to 30 days post last dose (Up to 23 months)
Secondary	Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests	Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: TSH value > ULN and; with baseline TSH value <= ULN; with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test; with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test; with FT3/FT4 missing within 2-week window after the abnormal TSH test.; TSH < LLN and; with baseline TSH value >= LLN; with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test; with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test; with FT3/FT4 missing within 2-week window after the abnormal TSH test	From first dose to up to 30 days post last dose (Up to 23 months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting