Esophageal Cancer Clinical Trial
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
Summary
This study will evaluate the safety and efficacy of the anti-T cell immunoglobulin and ITIM domain (TIGIT) monoclonal antibody domvanalimab, the anti-programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy in the first-line setting, and of domvanalimab and zimberelimab in the second-line or greater setting in participants with locally advanced unresectable or metastatic esophageal, gastroesophageal junction (GEJ), and gastric adenocarcinoma.
Eligibility Criteria
Key Inclusion Criteria:
Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma with life expectancy ≥3 months as assessed by the Investigator
Eastern cooperative oncology group (ECOG) Performance Score of 0-1
At least one measurable target lesion per RECIST v1.1.
Adequate organ and marrow function
Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central immunotherapy-drugs-are-boosting-survival/" >PD-L1 testing
Key Exclusion Criteria:
Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous
Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 (HER-2) positive tumor
Known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
Discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-TIGIT monoclonal antibody.
History of trauma or major surgery within 28 days prior to enrollment.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 19 Locations for this study
Phoenix Arizona, 85054, United States
Los Angeles California, 90033, United States
Santa Monica California, 90024, United States
Derby Connecticut, 06418, United States
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32224, United States
Saint Petersburg Florida, 33705, United States
Boston Massachusetts, 02109, United States
Buffalo New York, 14203, United States
New York New York, 10032, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Columbus Ohio, 43219, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19104, United States
Spartanburg South Carolina, 29307, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Fairfax Virginia, 22031, United States
Toronto , , Canada
Bordeaux , , France
Brest , , France
Caen , , France
Lille , , France
Lyon , , France
Marseille , , France
Montpellier , , France
Plérin , , France
Poitiers , , France
Rouen , , France
Toulouse , , France
Villejuif , , France
Busan , , Korea, Republic of
Daegu , , Korea, Republic of
Hwasun , , Korea, Republic of
Junggu , , Korea, Republic of
Seongnam , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Suwon-si , , Korea, Republic of
Suwon , , Korea, Republic of
Belgrade , , Serbia
Belgrad , , Serbia
Belgrad , , Serbia
Kragujevac , , Serbia
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