A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
NCT ID: NCT05329766
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
332 participants
INTERVENTIONAL
2022-06-10
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A1: First Line - Treatment Naïve Participants
Domvanalimab and zimberelimab once every 4 weeks (Q4W) in addition to FOLFOX chemotherapy by intravenous (IV) infusion once every 2 weeks (Q2W)
Domvanalimab
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Fluorouracil
Administered as specified in the treatment arm
Leucovorin
Administered as specified in the treatment arm
Oxaliplatin
Administered as specified in the treatment arm
A2: First Line - Treatment Naïve Participants
Zimberelimab Q4W in addition to chemotherapy with FOLFOX administered by IV infusion Q2W
Zimberelimab
Administered as specified in the treatment arm
Fluorouracil
Administered as specified in the treatment arm
Leucovorin
Administered as specified in the treatment arm
Oxaliplatin
Administered as specified in the treatment arm
A3 First Line - Treatment Naïve Participants
Non-randomized A3 safety run-in cohort: Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 60 minutes in addition to FOLFOX chemotherapy via IV infusion Q2W.
After completion of A3 safety run-in cohort, participants are randomized to the A3 arm. Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W
Domvanalimab
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Fluorouracil
Administered as specified in the treatment arm
Leucovorin
Administered as specified in the treatment arm
Oxaliplatin
Administered as specified in the treatment arm
A4 First Line - Treatment Naïve Participants
Zimberelimab administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W
Zimberelimab
Administered as specified in the treatment arm
Fluorouracil
Administered as specified in the treatment arm
Leucovorin
Administered as specified in the treatment arm
Oxaliplatin
Administered as specified in the treatment arm
B1: Second Line or greater Checkpoint Inhibitor Naïve Participants
Domvanalimab and zimberelimab administered once every three weeks (Q3W) by IV infusion
Domvanalimab
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
B2: Second Line or greater Checkpoint Inhibitor Naïve Participants
Quemliclustat Q2W and zimberelimab Q4W administered by IV infusion
Quemliclustat
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Cohort C1: Second Line or greater - Checkpoint Inhibitor Experienced Participants
Domvanalimab and zimberelimab Q3W administered by IV infusion
Domvanalimab
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Interventions
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Domvanalimab
Administered as specified in the treatment arm
Quemliclustat
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Fluorouracil
Administered as specified in the treatment arm
Leucovorin
Administered as specified in the treatment arm
Oxaliplatin
Administered as specified in the treatment arm
Eligibility Criteria
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Inclusion Criteria
* 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 PD-L1 testing
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Arcus Biosciences, Inc.
Locations
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Mayo Clinic - Arizona
Phoenix, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Santa Monica, California, United States
Yale Cancer Center
Derby, Connecticut, United States
Florida Cancer Specialist - South
Fort Myers, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Florida Cancer Specialist - North
St. Petersburg, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Columbia University
New York, New York, United States
Duke University
Durham, North Carolina, United States
Zangmeister Cancer Center
Columbus, Ohio, United States
OU - Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
SCRI Tennessee Oncology - Nashville
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
UHN - Princess Margaret Cancer Centre
Toronto, , Canada
Clínica San Carlos de Apoquindo
Las Condes, , Chile
Bradford Hill Centro de Investigaciones Clinicas
Recoleta, , Chile
Centro de Estudios Clínicos SAGA
Santiago, , Chile
Clínica Universidad Católica del Maule
Talca, , Chile
Institut Bergonié _ Bordeaux
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
CHU de Toulouse_Oncopole
Toulouse, , France
Gustave Roussy - Villejuif
Villejuif, , France
MSB - Medicinski Sistem Beograd
Belgrade, , Serbia
University Clinical Center of Serbia
Belgrade, , Serbia
University Hospital Medical Center (KBC) Bezanijska Kosa
Belgrade, , Serbia
Institute of Oncology of Vojvodina
Kamenitz, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Dong-A University Hospital
Busan, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
CHA Bundang Medical Center
Seongnam-si, , South Korea
Asan Medical Center Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Cancer Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
St. Vincent's Hospital, The Catholic University of Korea
Suwon, , South Korea
Countries
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References
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Janjigian YY, Oh DY, Pelster M, Wainberg ZA, Prusty S, Nelson S, DuPage A, Thompson A, Koralek DO, Sison EAR, Rha SY. Domvanalimab and zimberelimab in advanced gastric, gastroesophageal junction or esophageal cancer: a phase 2 trial. Nat Med. 2025 Dec;31(12):4274-4280. doi: 10.1038/s41591-025-04022-w. Epub 2025 Oct 18.
Related Links
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ARC-21 - Public website
Other Identifiers
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2021-006291-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-511917-40-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARC-21
Identifier Type: -
Identifier Source: org_study_id