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A Study to Test Combination Treatments in Participants 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02935634
Recruitment Status : Active, not recruiting
First Posted : October 17, 2016
Last Update Posted : May 6, 2022
Sponsor:
Collaborator:
Clovis Oncology, Inc.
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of Nivolumab in combination with Ipilimumab or other treatment therapies in participants 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)
Actual Enrollment : 190 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 29, 2016
Estimated Primary Completion Date : May 21, 2023
Estimated Study Completion Date : May 21, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Active Comparator: Nivolumab + Ipilimumab Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016

Experimental: Nivolumab + Relatlimab Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Biological: Relatlimab
Specified dose on specified days
Other Name: BMS-986016

Experimental: Nivolumab + BMS-986205 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Biological: BMS-986205
Specified dose on specified days

Experimental: Nivolumab + Rucaparib Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Rucaparib
Specified dose on specified days
Other Name: Rubraca

Experimental: Ipilimumab + Rucaparib Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016

Drug: Rucaparib
Specified dose on specified days
Other Name: Rubraca

Experimental: Nivolumab + Ipilimumab + Rucaparib Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016

Drug: Rucaparib
Specified dose on specified days
Other Name: Rubraca




Primary Outcome Measures :
  1. Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator [ Time Frame: Up to 24 months ]
  2. Duration of Response (DOR) by RECIST v1.1 by Investigator [ 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 (SAEs) 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 participants with clinical laboratory abnormalities in Part 1 [ Time Frame: Approximately 28 Months ]

Secondary Outcome Measures :
  1. Incidence of AEs [ Time Frame: Approximately 28 months ]
  2. Incidence of 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 participants with 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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inoperable, advanced or metastatic esophageal cancer (EC), gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed predominant adenocarcinoma and/or squamous carcinoma
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • At least 1 lesion with measurable disease

Exclusion Criteria:

  • HER2-positive tumor and previously untreated with trastuzumab
  • Suspected, known or progressive central nervous system metastases
  • Other active malignancy requiring concurrent intervention
  • Active, known or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria 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


Locations
Show Show 35 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    
Other Study ID Numbers: CA018-003
2016-002807-24 ( EudraCT Number )
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022

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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
Linrodostat
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors