Trial record 8 of 11 for:    BMS-986016

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 : March 13, 2018
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

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
Drug Information available for: Nivolumab
U.S. FDA Resources

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, Senior)
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

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 identifier (NCT number): NCT02935634

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 #.

  Show 40 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb 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: March 13, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs