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.

View Eligibility Criteria

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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

360

Study ID:

NCT05329766

Recruitment Status:

Recruiting

Sponsor:

Arcus Biosciences, Inc.

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There are 19 Locations for this study

See Locations Near You

Mayo Clinic - Arizona
Phoenix Arizona, 85054, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Ronald Reagan UCLA Medical Center
Santa Monica California, 90024, United States
Yale Cancer Center
Derby Connecticut, 06418, United States
Florida Cancer Specialist - North
Fort Myers Florida, 33901, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Florida Cancer Specialist - South
Saint Petersburg Florida, 33705, United States
Massachusetts General Hospital
Boston Massachusetts, 02109, United States
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14203, United States
Columbia University
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Duke University
Durham North Carolina, 27710, United States
Zangmeister Cancer Center
Columbus Ohio, 43219, United States
OU - Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Prisma Health Cancer Institute
Spartanburg South Carolina, 29307, United States
SCRI Tennessee Oncology - Nashville
Nashville Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
Virginia Cancer Specialists-Fairfax Office
Fairfax Virginia, 22031, United States
UHN - Princess Margaret Cancer Centre
Toronto , , Canada
Institut Bergonié
Bordeaux , , France
CHU de Brest_Brest
Brest , , France
Centre Baclesse - CAEN
Caen , , France
Centre Oscar Lambret _ LILLE
Lille , , France
Centre Léon Bérard _ Lyon
Lyon , , France
Hôpital Timone - Marseille
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
Centre Henri Becquerel - Rouen
Rouen , , France
CHU de Toulouse_Oncopole
Toulouse , , France
Gustave Roussy - Villejuif
Villejuif , , 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
Chungnam National University Hospital
Junggu , , Korea, Republic of
CHA Bundang Medical Center
Seongnam , , Korea, Republic of
Asan Medical Center Hospital
Seoul , , Korea, Republic of
Korea University Anam 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
The Catholic University of Korea Seoul Saint Mary's Hospital
Seoul , , Korea, Republic of
St. Vincent's Hospital, The Catholic University of Korea
Suwon-si , , Korea, Republic of
Ajou University Hospital
Suwon , , Korea, Republic of
University Hospital Medical Center (KBC) Bezanijska Kosa
Belgrade , , Serbia
MSB - Medicinski Sistem Beograd
Belgrad , , Serbia
University Clinical Center of Serbia
Belgrad , , Serbia
Clinical Center Kragujevac
Kragujevac , , Serbia

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

360

Study ID:

NCT05329766

Recruitment Status:

Recruiting

Sponsor:


Arcus Biosciences, Inc.

How clear is this clinincal trial information?

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