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ACTIVE NOT RECRUITING Phase 3

A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body

NCT05568095 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Capecitabine
  • DRUG Fluorouracil
  • DRUG Leucovorin
  • DRUG Zimberelimab
  • DRUG Domvanalimab

Study Locations (20)

California

  • Kaiser Permanente - Los Angeles Medical Center — Los Angeles
  • Norris Comprehensive Cancer Center — Los Angeles
  • University of California Irvine Health Chao Family Comprehensive Cancer Center — Orange
  • UCLA Health - Santa Monica Cancer Care — Santa Monica

Florida

  • SCRI - Florida Cancer Specialists - South Region Research Office — Fort Myers
  • SCRI - Florida Cancer Specialists - North Region Research Office — St. Petersburg
  • SCRI - Florida Cancer Specialists - Panhandle Research Office — Tallahassee
  • SCRI - Florida Cancer Specialists - East Region Research Office — West Palm Beach

Kentucky

  • University of Louisville James Graham Brown Cancer Center — Louisville
  • Norton Cancer Institute - Poplar Level Road — Louisville

Minnesota

  • HealthPartners Cancer Center at Regions Hospital — Saint Louis Park
  • Regions Hospital — Saint Louis Park

New York

  • Perlmutter Cancer Ctr NYU — Mineola
  • Perlmutter Cancer Center - 38th Street — New York

Arkansas

  • Genesis Cancer Center and Blood Institute - Hot Springs — Hot Springs

Connecticut

  • Yale Cancer Center — New Haven

District of Columbia

  • Georgetown Lombardi Comprehensive Cancer Center — Washington D.C.

Trial Details

FieldValue
Enrollment Target 1,040 participants
Start Date 2022-11-21
Est. Completion 2026-06
Phase Phase 3

Sponsor

Arcus Biosciences

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05568095

The ClinicalTrials.gov registry entry for NCT05568095 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,040 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arcus Biosciences, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced Upper Gastrointestinal Tract Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions — of which Capecitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05568095 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05568095 about?

NCT05568095 is a clinical study titled "A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body". 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 ...

What is the current status of trial NCT05568095?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,040 participants. The study started on 2022-11-21. Estimated completion is 2026-06.

What conditions does trial NCT05568095 study?

This clinical trial studies the following conditions: Advanced Upper Gastrointestinal Tract Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05568095?

The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Zimberelimab (DRUG), Domvanalimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05568095?

This trial is sponsored by Arcus Biosciences, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05568095 being conducted?

This trial has 20 study locations across Arkansas, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial