A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer

• Status: Active, not recruiting
• Trial end date: 2023-12-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Clovis Oncology, Inc.
• Treatments: Ipilimumab; Linrodostat; Nivolumab; Rucaparib

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