Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

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.

Official Title

A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

Keywords

Advanced Upper Gastrointestinal Tract Adenocarcinoma, Domvanalimab, Zimberelimab, Nivolumab, Gastroesophageal junction cancer, Esophageal adenocarcinoma, Gastric cancer, Gastric adenocarcinoma, Adenocarcinoma, Leucovorin, Capecitabine, Fluorouracil, Oxaliplatin

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age >= 18 years at the time of signing the informed consent.
  • Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.
  • Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
  • At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

You CAN'T join if...

  • Underlying medical or psychiatric conditions that, in the investigator's or sponsor's opinion, will make the administration of study-specified therapy hazardous, including but not limited to:
    • Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization.
    • Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina, or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization.
    • History of prior solid-organ transplantation, including allogenic bone marrow transplantation.
    • Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial.
  • Known human epidermal growth factor receptor 2 (HER-2) positive tumor.
  • Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
  • Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
  • Disease progression within 6 months of neoadjuvant or adjuvant chemotherapy.

    Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • University of California Irvine Health Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arcus Biosciences, Inc.
ID
NCT05568095
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 970 study participants
Last Updated