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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 : October 28, 2019
Sponsor:
Collaborator:
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  (Clinical Trial)
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 : June 23, 2022
Estimated Study Completion Date : June 23, 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

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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
  • 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 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 #.

  Show 45 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Clovis Oncology, Inc.
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: October 28, 2019
Last Verified: October 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
Rucaparib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action