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

Status: Active

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.

Eligibility Criteria

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)

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Connecticut

New Haven
Yale University
Status: Active
Contact: Kamil Sadowski
Phone: 203-785-6661
Email: kamil.sadowski@yale.edu

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Florida

Jacksonville
Mayo Clinic in Florida
Status: Temporarily closed to accrual
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Temporarily closed to accrual
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: Active
Name Not Available
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA018-003
Secondary IDs NCI-2017-00025, 2016-002807-24
Clinicaltrials.gov ID NCT02935634