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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice) 		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
    Intravenous (IV) Aqueous Solution
    Other names:
    • AB154
  • Drug: Zimberelimab
    IV Aqueous Solution
    Other names:
    • AB122
  • Drug: Capecitabine
    Oral Tablets
  • Drug: Fluorouracil
    IV Aqueous Solution
  • Drug: Leucovorin
    IV Aqueous Solution
  • Drug: Oxaliplatin
    IV Aqueous Solution
Active Comparator
Nivolumab + FOLFOX/CAPOX (PI Choice) 		Participants in this arm will receive Nivolumab Q2W and FOLFOX Q2W or Nivolumab Q3W + CAPOX Q3W.
  • Drug: Capecitabine
    Oral Tablets
  • Drug: Fluorouracil
    IV Aqueous Solution
  • Drug: Leucovorin
    IV Aqueous Solution
  • Drug: Oxaliplatin
    IV Aqueous Solution
  • Drug: Nivolumab
    IV Aqueous Solution

Recruiting Locations

Georgetown Lombardi Comprehensive Cancer Center
Washington, District of Columbia 20007

More Details

Status
Recruiting
Sponsor
Arcus Biosciences, Inc.

Study Contact

Medical Director
+1-510-462-3330
ClinicalTrials@arcusbio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.