Esophageal Cancer Clinical Trial

A Safety and Efficacy Study of Domvanalimab + Zimberelimab Combination Therapy in 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic esophageal, GEJ, or gastric 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

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 symptomatic, actively progressing, or untreated CNS (brain or leptomeningeal) metastases.
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.
Use of any live vaccines against infectious diseases within 28 days prior to enrollment.

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT05329766

Recruitment Status:

Recruiting

Sponsor:

Arcus Biosciences, Inc.

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There are 11 Locations for this study

See Locations Near You

Mayo Clinic
Phoenix Arizona, 85054, United States
UCLA
Santa Monica California, 90024, United States
SCRI - Florida Cancer Specialists - North Region Research Office
Fort Myers Florida, 33901, United States
SCRI - Florida Cancer Specialists - South Region Research Office
Saint Petersburg Florida, 33705, United States
Massachusetts General Hospital
Boston Massachusetts, 02109, United States
New York-Presbyterian Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Zangmeister Cancer Center
Columbus Ohio, 43219, United States
Greenville Health System Cancer Institute (Prisma)
Spartanburg South Carolina, 29307, United States
SCRI Tennessee Oncology - Nashville
Nashville Tennessee, 37203, United States
Virginia Cancer Specialists-Fairfax Office
Fairfax Virginia, 22031, United States
Institut Bergonié
Bordeaux , , France
CHU de Brest_Brest
Brest , , France
Centre François Baclesse
Caen , , France
Hôpital Timone
Marseille , , France
Institut de Recherche en Cancerologie de Montpellier
Montpellier , , France
Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie
Plérin , , France
Pôle Régional de Cancérologie - Service d'Oncologie Médicale - Poitiers
Poitiers , , France
Dong-A University Hospital
Busan , , Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu , , Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun , , Korea, Republic of
CHA Bundang Medical Center
Seongnam , , Korea, Republic of
Asan Medical Center Hospital
Seoul , , Korea, Republic of
Korea University Guro Hospital
Seoul , , Korea, Republic of
Samsung Medical Center
Seoul , , Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
Severance Hospital Cancer Center
Seoul , , Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT05329766

Recruitment Status:

Recruiting

Sponsor:


Arcus Biosciences, Inc.

How clear is this clinincal trial information?

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