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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02935634




Registration number
NCT02935634
Ethics application status
Date submitted
14/10/2016
Date registered
17/10/2016
Date last updated
9/06/2023

Titles & IDs
Public title
A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer
Scientific title
A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer (FRACTION-Gastric Cancer)
Secondary ID [1] 0 0
2016-002807-24
Secondary ID [2] 0 0
CA018-003
Universal Trial Number (UTN)
Trial acronym
FRACTION-GC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Gastric Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Other - Ipilimumab
Treatment: Other - Relatlimab
Treatment: Other - BMS-986205
Treatment: Drugs - Rucaparib

Active comparator: Nivolumab + Ipilimumab -

Experimental: Nivolumab + Relatlimab -

Experimental: Nivolumab + BMS-986205 -

Experimental: Nivolumab + Rucaparib -

Experimental: Ipilimumab + Rucaparib -

Experimental: Nivolumab + Ipilimumab + Rucaparib -


Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Other: Ipilimumab
Specified dose on specified days

Treatment: Other: Relatlimab
Specified dose on specified days

Treatment: Other: BMS-986205
Specified dose on specified days

Treatment: Drugs: Rucaparib
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) by Investigator
Timepoint [1] 0 0
From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)
Primary outcome [2] 0 0
Median Duration of Response (DOR)
Timepoint [2] 0 0
From first dose to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 65 months)
Primary outcome [3] 0 0
Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks
Timepoint [3] 0 0
24 weeks after first dose
Secondary outcome [1] 0 0
Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death
Timepoint [1] 0 0
From first dose to 100 days after last dose of study therapy (assessed up to approximately 30 months)
Secondary outcome [2] 0 0
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Timepoint [2] 0 0
From first dose to 100 days after last dose of study therapy (approximately 30 months)
Secondary outcome [3] 0 0
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Timepoint [3] 0 0
From first dose to 100 days after last dose of study therapy (approximately 30 months)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/05/2022
Sample size
Target
Accrual to date
Final
190
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - 0035 - Westmead
Recruitment hospital [2] 0 0
Local Institution - 0033 - Heidelberg
Recruitment hospital [3] 0 0
Local Institution - Randwick
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Germany
State/province [18] 0 0
Heidelberg
Country [19] 0 0
Germany
State/province [19] 0 0
Leipzig
Country [20] 0 0
Israel
State/province [20] 0 0
Ramat Gan
Country [21] 0 0
Israel
State/province [21] 0 0
Tel Aviv
Country [22] 0 0
Italy
State/province [22] 0 0
Lombardia
Country [23] 0 0
Italy
State/province [23] 0 0
Milano
Country [24] 0 0
Netherlands
State/province [24] 0 0
Amsterdam
Country [25] 0 0
Netherlands
State/province [25] 0 0
Utrecht
Country [26] 0 0
Singapore
State/province [26] 0 0
Singapore
Country [27] 0 0
Switzerland
State/province [27] 0 0
Graubünden (de)
Country [28] 0 0
Switzerland
State/province [28] 0 0
Zuerich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Clovis Oncology, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02935634