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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002222-27-LT

Enrollment

970

Registered

2022-10-06

Start date

2022-12-12

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Esophageal or Gastric Cancer

Interventions

Product Name: Domvanalimab Product Code: AB154 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Domvanalimab CAS Number: 2368219-35-4 Current Sponsor code: AB154 Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma. •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. •At least one measurable target lesion per RECIST v1.1. •Adequate organ and marrow function •Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 436 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 534

Exclusion criteria

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 •Known HER-2-positive tumor. •Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. •Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma. •Use of any live vaccines within 28 days prior to randomization.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To compare overall survival (OS) of domvanalimab + zimberelimab + chemotherapy versus nivolumab + chemotherapy in participants with high PD-L1 expression. • To compare OS of domvanalimab + zimberelimab + chemotherapy versus nivolumab + chemotherapy in all randomized participants.;Secondary Objective: •To compare PFS of domvanalimab + zimberelimab + chemotherapy versus nivolumab + chemotherapy in participants with high PD-L1 expression •To compare PFS of domvanalimab + zimberelimab + chemotherapy versus nivolumab + chemotherapy in all randomized participants •To assess additional measures of clinical activity in participants with high PD-L1 expression and in all randomized participants •To assess the safety and tolerability of domvanalimab + zimberelimab + chemotherapy in all randomized participants ;Primary end point(s): • OS is defined as the length of time from date of randomization until the date of death from any cause;Timepoint(s) of evaluation of this end point: Please refer to the Protocol	—

Measure

Time frame

Main Objective: • To compare overall survival (OS) of domvanalimab + zimberelimab + chemotherapy versus nivolumab + chemotherapy in participants with high PD-L1 expression. • To compare OS of domvanalimab + zimberelimab + chemotherapy versus nivolumab + chemotherapy in all randomized participants.;Secondary Objective: •To compare PFS of domvanalimab + zimberelimab + chemotherapy versus nivolumab + chemotherapy in participants with high PD-L1 expression •To compare PFS of domvanalimab + zimberelimab + chemotherapy versus nivolumab + chemotherapy in all randomized participants •To assess additional measures of clinical activity in participants with high PD-L1 expression and in all randomized participants •To assess the safety and tolerability of domvanalimab + zimberelimab + chemotherapy in all randomized participants ;Primary end point(s): • OS is defined as the length of time from date of randomization until the date of death from any cause;Timepoint(s) of evaluation of this end point: Please refer to the Protocol

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Secondary

Measure	Time frame
Secondary end point(s): • PFS is defined as the length of time from date of randomization until disease progression or death from any cause, whichever comes first, as measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by the investigator. • Objective response rate (ORR) is defined as the proportion of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR) to study therapy as assessed by the investigator according to RECIST v1.1. • Duration of response (DOR) is measured from the time of first response (CR or PR as measured by RECIST v1.1) as assessed by the investigator, until the date of first documented disease progression or death, whichever comes first. • The incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and any clinically meaningful trends in safety parameters. ;Timepoint(s) of evaluation of this end point: Please, refer to the Protocol	—

Measure

Time frame

Secondary end point(s): • PFS is defined as the length of time from date of randomization until disease progression or death from any cause, whichever comes first, as measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by the investigator. • Objective response rate (ORR) is defined as the proportion of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR) to study therapy as assessed by the investigator according to RECIST v1.1. • Duration of response (DOR) is measured from the time of first response (CR or PR as measured by RECIST v1.1) as assessed by the investigator, until the date of first documented disease progression or death, whichever comes first. • The incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and any clinically meaningful trends in safety parameters. ;Timepoint(s) of evaluation of this end point: Please, refer to the Protocol

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Countries

Argentina, Australia, Brazil, Canada, Chile, France, Georgia, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Peru, Philippines, Poland, Portugal, Romania, Serbia, Spain, Thailand, Türkiye, United Kingdom, United States

Contacts

Public ContactAllan Sison, Medical Monitor

Arcus Biosciences, Inc.

asison@arcusbio.com+1510-359-5145

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026