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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.
ClinicalTrials.gov Identifier: NCT02935634
Recruitment Status : Recruiting
First Posted : October 17, 2016
Last Update Posted : May 30, 2019
Sponsor:
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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 17, 2021
Estimated Study Completion Date : November 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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

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

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

Biological: Relatlimab
Other Name: BMS-986016

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

Biological: BMS-986205



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 ]

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. AEs leading to discontinuation [ Time Frame: Approximately 28 months ]
  4. AEs leading to death [ Time Frame: Approximately 28 months ]


Information from the National Library of Medicine

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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
Criteria

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

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02935634


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

  Hide Study Locations
Locations
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United States, Arizona
Local Institution Not yet recruiting
Phoenix, Arizona, United States, 85054
Contact: Site 0037         
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: Stephen Leong, 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: Sunnie Kim, Site 0036         
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: Kristen Marrone, Site 0006         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Steven Alberts, 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 Cancer Center 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, 97213
Contact: Rom Leidner, Site 0002    503-215-5696      
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111-2412
Contact: Crystal Denlinger, Site 0005    215-728-5506      
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      
Australia
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 Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Site 0022         
Canada, Nova Scotia
Local Institution Withdrawn
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Local Institution Active, not recruiting
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         
France
Local Institution Not yet recruiting
Lyon Cedex 08, France, 69373
Contact: Site 0047         
Local Institution Not yet recruiting
Marseille Cedex 9, France, 13273
Contact: Site 0048         
Local Institution Not yet recruiting
Montpellier Cedex 5, France, 34298
Contact: Site 0046         
Local Institution Not yet recruiting
Villejuif, France, 94805
Contact: Site 0049         
Germany
Nationales Centrum Fur Tumorerkrankungen (Nct) Recruiting
Heidelberg, Germany, 69120
Contact: Georg Martin Haag, Site 0039    +4962215638687      
Universitaetsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Florian Lordick, Site 0043    +493419712560      
Israel
Local Institution Recruiting
Ramat Gan, Israel, 52621
Contact: Site 0018         
Local Institution Recruiting
Tel Aviv, Israel, 64239
Contact: Site 0019         
Italy
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      
Netherlands
Amsterdam UMC ? locatie AMC Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Hanneke Van Laarhoven, Site 0012         
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Nadia Haj Mohammad, Site 0031         
Singapore
Local Institution Recruiting
Singapore, Singapore, 169610
Contact: Site 0050         
Spain
Local Institution Not yet recruiting
Badalona-barcelona, Spain, 08916
Contact: Site 0044         
Local Institution Not yet recruiting
Madrid, Spain, 28041
Contact: Site 0045         
Switzerland
Kantonsspital Graubunden Recruiting
Chur, Switzerland, 7000
Contact: Roger Von Moos, Site 0041    +41812567581      
University Hospital Zurich Recruiting
Zuerich, Switzerland, 8091
Contact: Alexander Siebenhuener, Site 0042    +41432539803      
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02935634     History of Changes
Other Study ID Numbers: CA018-003
2016-002807-24 ( EudraCT Number )
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents