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A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer (FRACTION-GC)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02935634
Recruitment Status : Recruiting
First Posted : October 17, 2016
Last Update Posted : August 26, 2020
Clovis Oncology, Inc.
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Biological: Nivolumab Biological: Ipilimumab Biological: Relatlimab Biological: BMS-986205 Drug: Rucaparib Phase 2

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Study Type : Interventional
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 23, 2016
Estimated Primary Completion Date : November 18, 2021
Estimated Study Completion Date : December 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Active Comparator: Nivolumab (nivo) and Ipilimumab (ipi) Combination Biological: Nivolumab
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016

Experimental: nivo and Relatlimab Combination Biological: Nivolumab
Other Names:
  • Opdivo
  • BMS-936558

Biological: Relatlimab
Other Name: BMS-986016

Experimental: nivo and BMS-986205 Combination Biological: Nivolumab
Other Names:
  • Opdivo
  • BMS-936558

Biological: BMS-986205
Experimental: Nivo and rucaparib Combination Drug: Rucaparib
Other Name: Rubraca

Experimental: Ipi with rucaparib Combination Drug: Rucaparib
Other Name: Rubraca

Experimental: nivo with ipi and rucaparib Drug: Rucaparib
Other Name: Rubraca

Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]
  2. Duration of Response (DOR) [ Time Frame: Up to 24 months ]
  3. Progression-free Survival Rate (PFSR) [ Time Frame: Up to 24 months ]
  4. Incidence of Adverse Events (AEs) in Part 1 [ Time Frame: Approximately 28 Months ]
  5. Incidence of Serious Adverse Events in Part 1 [ Time Frame: Approximately 28 Months ]
  6. Incidence of AEs leading to Discontinuation in Part 1 [ Time Frame: Approximately 28 Months ]
  7. Incidence of Deaths in Part 1 [ Time Frame: Approximately 28 Months ]
  8. Incidence of Clinical Laboratory Abnormalities in Part 1 [ Time Frame: Approximately 28 Months ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Approximately 28 months ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 28 months ]
  3. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 28 months ]
  4. Incidence of AEs leading to death [ Time Frame: Approximately 28 months ]
  5. Incidence of Clinical laboratory test abnormalities [ Time Frame: Approximately 28 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit

Inclusion Criteria:

  • 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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02935634

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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Contact: First line of the email MUST contain NCT# and Site #.

Hide Hide 45 study locations
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United States, Arizona
Mayo Clinic Arizona Terminated
Phoenix, Arizona, United States, 85054
United States, California
City Of Hope National Medical Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Joseph Chao, Site 0020    626-218-7073      
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Sunnie Kim, Site 0011    720-848-9352      
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Stacey Stein, Site 0032    203-984-0020      
United States, District of Columbia
Georgetown University Med Ctr Recruiting
Washington, District of Columbia, United States, 20007
Contact: Aiwu He, Site 0036    202-444-1781      
United States, Florida
UF Health Medical Oncology - Davis Cancer Pavilion Recruiting
Gainesville, Florida, United States, 32610
Contact: Thomas George, Site 0009    352-732-4938      
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Jason Starr, Site 0038    904-953-3570      
Moffitt Cancer Center Withdrawn
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Withdrawn
Atlanta, Georgia, United States, 30322
United States, Maryland
John Hopkins Recruiting
Baltimore, Maryland, United States, 21224
Contact: Vincent Lam, Site 0006         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Harry Yoon, Site 0017    507-266-9161      
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Haeseong Park, Site 0003    314-362-5740      
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Martin Gutierrez, Site 0001    551-996-5900      
United States, New York
Memorial Sloan Kettering Nassau Recruiting
New York, New York, United States, 10065
Contact: Geoffrey Ku, Site 0007    646-888-4325      
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Gina Vaccaro, Site 0002    503-215-5696      
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111-2412
Contact: Crystal Denlinger, Site 0005    215-214-1676      
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Nathan Bahary, Site 0010    412-864-7764      
United States, Washington
Seattle Cancer Care Assoc. Univ of Washington Recruiting
Seattle, Washington, United States, 98109
Contact: Veena Shankaran, Site 0004    206-288-7017      
Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Adnan Nagrial, Site 0035    +61287453725      
Australia, Victoria
Austin Health Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Niall Tebbutt, Site 0033    +61394963297      
Local Institution Not yet recruiting
Randwick, Australia, 2031
Contact: Site 0034         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Michael Sawyer, Site 0029    7804328285      
Canada, British Columbia
Local Institution Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Local Institution Withdrawn
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Local Institution Completed
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Research Institution Active, not recruiting
Toronto,, Ontario, Canada, M4N 3M5
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0021         
Canada, Quebec
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 0051         
Local Institution Withdrawn
Lyon Cedex 08, France, 69373
Local Institution Withdrawn
Marseille Cedex 9, France, 13273
Local Institution Withdrawn
Montpellier Cedex 5, France, 34298
Local Institution Withdrawn
Villejuif, France, 94805
Nationales Centrum Fur Tumorerkrankungen (Nct) Recruiting
Heidelberg, Germany, 69120
Contact: Georg Martin Haag, Site 0039    +496221565982      
Universitaetsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Florian Lordick, Site 0043    +493419712560      
Local Institution Recruiting
Ramat Gan, Israel, 52621
Contact: Site 0018         
Local Institution Recruiting
Tel Aviv, Israel, 64239
Contact: Site 0019         
IRCCS Istituto Nazionale Tumori Milano Recruiting
Milano, Italy, 20133
Contact: Maria Di Bartolomeo, Site 0013    +390223903066      
Istituto Europeo Di Oncologia Recruiting
Milan, Italy, 20141
Contact: Giuseppe Curigliano, Site 0014    +390257489599      
Local Institution Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Site 0012         
Local Institution Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Site 0031         
Local Institution Recruiting
Singapore, Singapore, 169610
Contact: Site 0050         
Local Institution Withdrawn
Badalona-barcelona, Spain, 08916
Local Institution Withdrawn
Madrid, Spain, 28041
Kantonsspital Graubunden Recruiting
Chur, Switzerland, 7000
Contact: Roger Von Moos, Site 0041    +41812567581      
University Hospital Zuerich Recruiting
Zuerich, Switzerland, 8091
Contact: Ralph Fritsch, Site 0042    +41432539803      
Sponsors and Collaborators
Bristol-Myers Squibb
Clovis Oncology, Inc.
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT02935634    
Other Study ID Numbers: CA018-003
2016-002807-24 ( EudraCT Number )
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Stomach Diseases
Digestive System Diseases
Gastrointestinal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action