A Phase 3 interventional study of Domvanalimab and Zimberelimab in Advanced Upper Gastrointestinal Tract Adenocarcinoma, sponsored by Arcus Biosciences, Inc.. Completed at 168 sites in 29 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Arcus Biosciences, Inc. · Phase 3, Interventional, and Treatment
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Among 246 studies in Adenocarcinoma Of Esophagus with a site in United States — 53 open to participants now, 73 under way, 7 of them phase 3. Adenocarcinoma Of Esophagus · United States.
Among the 246 studies in Adenocarcinoma Of Esophagus with a site in United States, this one is the 5th largest by enrollment of the 203 interventional ones that give a count, is one of 7 that started in 2022, is one of 13 in phase 3, and was the 196th registered.
354 studies on the registry are indexed under Adenocarcinoma Of Esophagus; 81 are open to participants now.
Browse Adenocarcinoma Of Esophagus studies →53 of the 246 studies in Adenocarcinoma Of Esophagus with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18+
Case Comprehensive Cancer Center · Sites in United States
Ages 18+
Yale University · Sites in United States
Ages 18–80
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 70 Adenocarcinoma Of Esophagus studies recruiting now, 60 (86%) set no upper age limit and 2 (3%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
246 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 56 · Phase 2 150 · Phase 3 18 · Phase 4 2
First in 1995; this study’s year is marked. 7 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,040 is above the median of 51 across 277 interventional studies indexed under Adenocarcinoma Of Esophagus.
Median enrollment 49 across the 203 interventional studies, 155 across the 23 observational. Of the 156 that completed or were terminated, 63 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
57 of 246 have an industry lead sponsor. The 10 most frequent:
Arcus Biosciences, Inc. is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Arcus Biosciences, Inc. has 2 studies filed under Adenocarcinoma Of Esophagus — fewer than ten, so there is no comparison to draw.
18 of the studies in Adenocarcinoma Of Esophagus with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06203600Phase 3National Cancer Institute (NCI)Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial | 2027-10-31 |
| NCT02962063Memorial Sloan Kettering Cancer CenterDurvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer | 2026-11 |
| NCT06532734Denver Health and Hospital AuthorityBarrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype | 2026-11 |
| NCT07023731Arvinas Inc.A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation | 2026-11-30 |
| NCT04900818I-Mab Biopharma US LimitedStudy of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors | 2026-12 |
Add all 18 to your calendar (.ics) → With an account.
Among the 246 studies in Adenocarcinoma Of Esophagus with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The standard rules for measuring tumors on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumor 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumors on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumor 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive Domvanalimab and zimberelimab doses once every 4 weeks (Q4W) in addition to chemotherapy with FOLFOX (oxaliplatin, leucovorin, fluorouracil) once every 2 weeks (Q2W) or Domvanalimab and zimberelimab once every 3 weeks (Q3W) in addition to chemotherapy with CAPOX (capecitabine and oxaliplatin) Q3W.
Drug: Domvanalimab · Drug: Zimberelimab · Drug: Capecitabine · Drug: Fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin
Participants in this arm will receive Nivolumab Q2W and FOLFOX Q2W or Nivolumab Q3W + CAPOX Q3W.
Drug: Capecitabine · Drug: Fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin · Drug: Nivolumab
Intravenous (IV) Aqueous Solution
Also known as: AB154
IV Aqueous Solution
Also known as: AB122
Oral Tablets
IV Aqueous Solution
IV Aqueous Solution
IV Aqueous Solution
IV Aqueous Solution
Overall survival
Time frame: From date of randomization until date of death from any cause (Approximately 15 months)]
Progression-free survival (PFS)
Time frame: From date of randomization to date of the first documentation of disease progression or date of death from any cause, whichever comes first (Approximately 15 months)
Objective response rate (ORR)
Time frame: Proportion of randomized participants who achieved a confirmed best overall response of complete response (CR) or partial response (PR) (Approximately 15 months)
Duration of response (DOR)
Time frame: From the date of first confirmed response (CR or PR), until the date of first documented disease progression or date of death from any cause, whichever comes first (Approximately 15 months)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From on or after the date of first dose of any study treatment to the date of last study treatment specific safety follow-up or date of initiation of subsequent systemic anti-cancer therapy, whichever occurs first (Approximately 15 months)
Time to first symptom deterioration in the FACT-Ga gastric cancer subscale.
Time frame: From the date of randomization to change from baseline in subscale greater than or equal to the deterioration threshold, or death from any cause, whichever comes first (Approximately 15 months)
Showing the first 100 of 168 sites across 29 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Arcus will provide access to individual de-identified participant data and related study documents [e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)] upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Data sharing details ↗ · trials.arcusbio.com
Ran from Nov 2022 to primary completion in Aug 2026, 45 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Domvanalimab · Zimberelimab