Description:
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.
Title
- Brief Title: A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer
- 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)
Clinical Trial IDs
- ORG STUDY ID:
CA018-003
- SECONDARY ID:
2016-002807-24
- NCT ID:
NCT02935634
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo, BMS-936558 | Nivo and BMS-986205 Combination |
Ipilimumab | Yervoy, BMS-734016 | Nivolumab (nivo) and Ipilimumab (ipi) Combination |
Relatlimab | BMS-986016 | Nivo and Relatlimab Combination |
BMS-986205 | | Nivo and BMS-986205 Combination |
Rucaparib | Rubraca | Ipi with Rucaparib Combination |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Nivolumab (nivo) and Ipilimumab (ipi) Combination | Active Comparator | | |
Nivo and Relatlimab Combination | Experimental | | |
Nivo and BMS-986205 Combination | Experimental | | |
Nivo and Rucaparib Combination | Experimental | | |
Ipi with Rucaparib Combination | Experimental | | |
Nivo with Ipi and rucaparib | Experimental | | |
Eligibility 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
Maximum Eligible Age: | 110 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Incidence of Adverse Events (AEs) |
Time Frame: | Approximately 28 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of Serious Adverse Events (SAEs) |
Time Frame: | Approximately 28 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of AEs leading to discontinuation |
Time Frame: | Approximately 28 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of AEs leading to death |
Time Frame: | Approximately 28 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of Clinical laboratory test abnormalities |
Time Frame: | Approximately 28 Months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
July 19, 2021