Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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.
Trial website
https://clinicaltrials.gov/study/NCT02935634
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02935634