A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer (FRACTION-GC)
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| ClinicalTrials.gov Identifier: NCT02935634 |
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Recruitment Status :
Completed
First Posted : October 17, 2016
Results First Posted : June 9, 2023
Last Update Posted : June 9, 2023
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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 |
| Actual Primary Completion Date : | May 11, 2022 |
| Actual Study Completion Date : | May 11, 2022 |
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 Investigator [ Time Frame: From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months) ]ORR is the percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.
- Median Duration of Response (DOR) [ Time Frame: From first dose to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 65 months) ]Duration of Response (DOR) is the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurred first. Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Median computed using Kaplan -Meier method.
- Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks [ Time Frame: 24 weeks after first dose ]The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula.
Secondary Outcome Measures :
- Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death [ Time Frame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 30 months) ]An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
- Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests [ Time Frame: From first dose to 100 days after last dose of study therapy (approximately 30 months) ]The number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
- Number of Participants With Laboratory Abnormalities in Specific Liver Tests [ Time Frame: From first dose to 100 days after last dose of study therapy (approximately 30 months) ]The number of participants with laboratory abnormalities in specific liver tests based on US conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
Study Documents (Full-Text)
Documents provided by Bristol-Myers Squibb:
Documents provided by Bristol-Myers Squibb:
Study Protocol and Statistical Analysis Plan [PDF] August 13, 2021
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 |
| Results First Posted: | June 9, 2023 |
| Last Update Posted: | June 9, 2023 |
| Last Verified: | May 2023 |
| 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 |