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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2026-05-08

No results posted yet for this 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.

Conditions

  • Advanced Upper Gastrointestinal Tract Adenocarcinoma

Interventions

DRUG

Domvanalimab

Intravenous (IV) Aqueous Solution

DRUG

Zimberelimab

IV Aqueous Solution

DRUG

Capecitabine

Oral Tablets

DRUG

Fluorouracil

IV Aqueous Solution

DRUG

Leucovorin

IV Aqueous Solution

DRUG

Oxaliplatin

IV Aqueous Solution

DRUG

Nivolumab

IV Aqueous Solution

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Taiho Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Arcus Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Arcus Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Chile
  • China
  • France
  • Georgia
  • Guatemala
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Lithuania
  • Malaysia
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Serbia
  • South Korea
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05568095 on ClinicalTrials.gov