Clinical trial NCT03704077: An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Official title: A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination With Various Standard-of-Care Therapeutic Regimens, in Participants With Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Gastric Cancer
Cancer of the Stomach
Stomach Cancer
Gastroesophageal Junction
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-10-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 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

Exclusion Criteria:

* Must not have squamous cell or undifferentiated GC or GEJ
* Untreated known central nervous system (CNS) metastases
* Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Approximately 31 months
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Approximately 5 years
measure: Incidence of serious adverse events (SAEs)
timeFrame: Approximately 5 years
measure: Incidence of AEs leading to discontinuation
timeFrame: Approximately 5 years
measure: Incidence of deaths
timeFrame: Approximately 5 years
measure: Incidence of laboratory abnormalities
timeFrame: Approximately 5 years
measure: ORR
timeFrame: Approximately 5 years
measure: Duration of response (DOR)
timeFrame: Approximately 5 years
measure: Progression free survival (PFS)
timeFrame: Approximately 5 years
measure: Overall survival (OS)
timeFrame: Approximately 5 years
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Local Institution
state: Alabama
city: Bakersfield
country: United States
facility: Local Institution
state: California
city: Fullerton
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Redondo Beach
country: United States
facility: Local Institution
state: California
city: Santa Barbara
country: United States
facility: Local Institution
state: California
city: Aurora
country: United States
facility: Local Institution
state: Colorado
city: Lakewood
country: United States
facility: Local Institution
state: Colorado
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Marietta
country: United States
facility: Local Institution
state: Georgia
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Saint Louis
country: United States
facility: Local Institution
state: Missouri
city: New Brunswick
country: United States
facility: Local Institution
state: New Jersey
city: Chapel Hill
country: United States
facility: Local Institution
state: North Carolina
city: Charlotte
country: United States
facility: Local Institution
state: North Carolina
city: Fargo
country: United States
facility: Local Institution
state: North Dakota
city: Allentown
country: United States
facility: Local Institution
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Local Institution
state: South Dakota
city: Vancouver
country: United States
facility: Local Institution
state: Washington
city: Viedma
country: Argentina
facility: Local Institution
state: RIO Negro
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Caba
country: Argentina
facility: Local Institution
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Westmead
country: Australia
facility: Local Institution
state: New South Wales
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Malvern
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Bedford Park
country: Australia
facility: Local Institution
city: Murdoch
country: Australia
facility: Local Institution
city: Fortaleza
country: Brazil
facility: Local Institution
state: Ceara
city: Belo Horizonte
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Jau
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution
state: Quebec
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Medellin
country: Colombia
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Cologne
country: Germany
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Frankfurt am Main
country: Germany
facility: Local Institution
city: Freiburg
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Jena
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Marburg
country: Germany
facility: Local Institution
city: Paderborn
country: Germany
facility: Local Institution
city: Reutlingen
country: Germany
facility: Local Institution
city: Wiesbaden
country: Germany
facility: Local Institution
city: Bergamo
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Reggio Emilia
country: Italy
facility: Local Institution
city: Tuxtla Gutierrez
country: Mexico
facility: Local Institution
state: Chiapas
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: ZONA Centro. LEON
country: Mexico
facility: Local Institution
state: Guanajuato
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Porto
country: Portugal
facility: Local Institution
city: Rio Piedras
country: Puerto Rico
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Cluj-Napoca
country: Romania
facility: Local Institution
city: Craiova
country: Romania
facility: Local Institution
city: Floresti
country: Romania
facility: Local Institution
city: Badajoz
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: