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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02935634
Ethics application status
Date submitted
14/10/2016
Date registered
17/10/2016
Date last updated
26/08/2020

Titles & IDs
Public title
A Study to Test Combination Treatments in Patients 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
Other interventions - Nivolumab
Other interventions - Ipilimumab
Other interventions - Relatlimab
Other interventions - BMS-986205
Treatment: Drugs - Rucaparib

Active Comparator: Nivolumab (nivo) and Ipilimumab (ipi) Combination -

Experimental: nivo and Relatlimab Combination -

Experimental: nivo and BMS-986205 Combination -

Experimental: Nivo and rucaparib Combination -

Experimental: Ipi with rucaparib Combination -

Experimental: nivo with ipi and rucaparib -


Other interventions: Nivolumab


Other interventions: Ipilimumab


Other interventions: Relatlimab


Other interventions: BMS-986205


Treatment: Drugs: Rucaparib


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 24 months
Primary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to 24 months
Primary outcome [3] 0 0
Progression-free Survival Rate (PFSR)
Timepoint [3] 0 0
Up to 24 months
Primary outcome [4] 0 0
Incidence of Adverse Events (AEs) in Part 1
Timepoint [4] 0 0
Approximately 28 Months
Primary outcome [5] 0 0
Incidence of Serious Adverse Events in Part 1
Timepoint [5] 0 0
Approximately 28 Months
Primary outcome [6] 0 0
Incidence of AEs leading to Discontinuation in Part 1
Timepoint [6] 0 0
Approximately 28 Months
Primary outcome [7] 0 0
Incidence of Deaths in Part 1
Timepoint [7] 0 0
Approximately 28 Months
Primary outcome [8] 0 0
Incidence of Clinical Laboratory Abnormalities in Part 1
Timepoint [8] 0 0
Approximately 28 Months
Secondary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Approximately 28 months
Secondary outcome [2] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Approximately 28 months
Secondary outcome [3] 0 0
Incidence of AEs leading to discontinuation
Timepoint [3] 0 0
Approximately 28 months
Secondary outcome [4] 0 0
Incidence of AEs leading to death
Timepoint [4] 0 0
Approximately 28 months
Secondary outcome [5] 0 0
Incidence of Clinical laboratory test abnormalities
Timepoint [5] 0 0
Approximately 28 Months

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



- Advanced Gastric Cancer

- Must have full activity or, if limited, must be able to walk and carry out light
activities such as light house work or office work

- Must have at least 1 lesion with measurable disease

- All participants must have inoperable, advanced, or metastatic EC, GC or GEJ carcinoma
and have histologically confirmed predominant adenocarcinoma or squamous cell
carcinoma. (sub protocol C)
Minimum age
18 Years
Maximum age
110 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients/subjects with HER2 positive tumor that have not been treated with trastuzumab
prior to enrollment

- Must not have suspected or known central nervous system metastases unless adequately
treated

- Patients/subjects with autoimmune disease

- Patients/subjects who need daily oxygen therapy

- Participants who are considered to be refractory or resistant to platinum agents (sub
protocol c)

- Participants who have inability to swallow capsules or pills (sub protocol c)

- Current or recent (within 3 months of study treatment administration) gastrointestinal
disease that could interfere with absorption of orally administered systemic
treatments (sub protocol c)

- Participants with diagnosis or history of myelodysplastic syndrome (MDS) or acute
myeloid leukemia (AML). (sub protocol C)

- Prior treatment with a PARP inhibitor (such as rucaparib, olaparib, niraparib,
talozaparib, etc.) or a targeted DNA damage response inhibitor (such as ATM or ataxia
telangiectasia and Rad3-related protein [ATR] inhibitor). (sub protocol C)

Other protocol defined inclusion/exclusion criteria could 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Austin Health - 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
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Nova Scotia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
France
State/province [21] 0 0
Lyon Cedex 08
Country [22] 0 0
France
State/province [22] 0 0
Marseille Cedex 9
Country [23] 0 0
France
State/province [23] 0 0
Montpellier Cedex 5
Country [24] 0 0
France
State/province [24] 0 0
Villejuif
Country [25] 0 0
Germany
State/province [25] 0 0
Heidelberg
Country [26] 0 0
Germany
State/province [26] 0 0
Leipzig
Country [27] 0 0
Israel
State/province [27] 0 0
Ramat Gan
Country [28] 0 0
Israel
State/province [28] 0 0
Tel Aviv
Country [29] 0 0
Italy
State/province [29] 0 0
Milano
Country [30] 0 0
Italy
State/province [30] 0 0
Milan
Country [31] 0 0
Netherlands
State/province [31] 0 0
Amsterdam
Country [32] 0 0
Netherlands
State/province [32] 0 0
Utrecht
Country [33] 0 0
Singapore
State/province [33] 0 0
Singapore
Country [34] 0 0
Spain
State/province [34] 0 0
Badalona-barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Switzerland
State/province [36] 0 0
Chur
Country [37] 0 0
Switzerland
State/province [37] 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 determine whether Nivolumab in combination with other
therapies is more effective than Nivolumab in combination with Ipilimumab in treating
patients/subjects with advanced gastric cancer.
Trial website
https://clinicaltrials.gov/show/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
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email:
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

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