A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer (FRACTION-GC)
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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 |
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Recruitment Status :
Active, not recruiting
First Posted : October 17, 2016
Last Update Posted : December 2, 2022
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Clovis Oncology, Inc.
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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 |
| 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:
Biological: Ipilimumab Specified dose on specified days
Other Names:
|
| Experimental: Nivolumab + Relatlimab |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Relatlimab Specified dose on specified days
Other Name: BMS-986016 |
| Experimental: Nivolumab + BMS-986205 |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: BMS-986205 Specified dose on specified days |
| Experimental: Nivolumab + Rucaparib |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Drug: Rucaparib Specified dose on specified days
Other Name: Rubraca |
| Experimental: Ipilimumab + Rucaparib |
Biological: Ipilimumab
Specified dose on specified days
Other Names:
Drug: Rucaparib Specified dose on specified days
Other Name: Rubraca |
| Experimental: Nivolumab + Ipilimumab + Rucaparib |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
Drug: Rucaparib Specified dose on specified days
Other Name: Rubraca |
Primary Outcome Measures :
- Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator [ Time Frame: Up to 24 months ]
- Duration of Response (DOR) by RECIST v1.1 by Investigator [ Time Frame: Up to 24 months ]
- Progression-free Survival Rate (PFSR) [ Time Frame: Up to 24 months ]
- Incidence of Adverse Events (AEs) in Part 1 [ Time Frame: Approximately 28 Months ]
- Incidence of Serious Adverse Events (SAEs) in Part 1 [ Time Frame: Approximately 28 Months ]
- Incidence of AEs leading to discontinuation in Part 1 [ Time Frame: Approximately 28 Months ]
- Incidence of deaths in Part 1 [ Time Frame: Approximately 28 Months ]
- Incidence of participants with clinical laboratory abnormalities in Part 1 [ Time Frame: Approximately 28 Months ]
Secondary Outcome Measures :
- Incidence of AEs [ Time Frame: Approximately 28 months ]
- Incidence of SAEs [ Time Frame: Approximately 28 months ]
- Incidence of AEs leading to discontinuation [ Time Frame: Approximately 28 months ]
- Incidence of AEs leading to death [ Time Frame: Approximately 28 months ]
- 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 35 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Clovis Oncology, Inc.
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| 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: | December 2, 2022 |
| Last Verified: | November 2022 |
| 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 |
Relatlimab Rucaparib Linrodostat Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors |