Clinical trial NCT02935634: A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer
Official title: A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer (FRACTION-Gastric Cancer)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Clovis Oncology, Inc.
First posted: 2016-10-17
Enrollment: 190
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 evaluate the preliminary efficacy, safety, and tolerability of Nivolumab in combination with Ipilimumab or other treatment therapies in participants with advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Inoperable, advanced or metastatic esophageal cancer (EC), gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed predominant adenocarcinoma and/or squamous carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
* At least 1 lesion with measurable disease

Exclusion Criteria:

* HER2-positive tumor and previously untreated with trastuzumab
* Suspected, known or progressive central nervous system metastases
* Other active malignancy requiring concurrent intervention
* Active, known or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Objective Response Rate (ORR) by Investigator
timeFrame: From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)
measure: Median Duration of Response (DOR)
timeFrame: From first dose to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 65 months)
measure: Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks
timeFrame: 24 weeks after first dose
Secondary outcomes:
measure: Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death
timeFrame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 30 months)
measure: Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From first dose to 100 days after last dose of study therapy (approximately 30 months)
measure: Number of Participants With Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first dose to 100 days after last dose of study therapy (approximately 30 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Duarte
country: United States
facility: Local Institution - 0020
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: New Haven
country: United States
facility: Local Institution - 0032
state: Connecticut
city: Washington
country: United States
facility: Local Institution - 0036
state: District of Columbia
city: Gainesville
country: United States
facility: UF Health Medical Oncology - Davis Cancer Pavilion
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 0038
state: Florida
city: Baltimore
country: United States
facility: Local Institution - 0006
state: Maryland
city: Rochester
country: United States
facility: Local Institution - 0017
state: Minnesota
city: Saint Louis
country: United States
facility: Local Institution - 0003
state: Missouri
city: Hackensack
country: United States
facility: Local Institution - 0001
state: New Jersey
city: New York
country: United States
facility: Local Institution - 0007
state: New York
city: Portland
country: United States
facility: Local Institution - 0002
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution - 0005
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Seattle
country: United States
facility: Local Institution - 0004
state: Washington
city: Westmead
country: Australia
facility: Local Institution - 0035
state: New South Wales
city: Heidelberg
country: Australia
facility: Local Institution - 0033
state: Victoria
city: Randwick
country: Australia
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto,
country: Canada
facility: Local Institution - 0025
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0021
state: Ontario
city: Heidelberg
country: Germany
facility: Local Institution - 0039
city: Leipzig
country: Germany
facility: Local Institution - 0043
city: Ramat Gan
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Milan
country: Italy
facility: Local Institution - 0014
state: Lombardia
city: Milano
country: Italy
facility: IRCCS Istituto Nazionale Tumori Milano
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Utrecht
country: Netherlands
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution - 0050
city: Chur
country: Switzerland
facility: Local Institution - 0041
state: Graubünden (de)
city: Zuerich
country: Switzerland
facility: Local Institution - 0042
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: