2023-507522-16-00
Active, not recruiting
Phase 3
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
Arcus Biosciences Inc.47 sites in 9 countries152 target enrollmentStarted: August 29, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Arcus Biosciences Inc.
- Enrollment
- 152
- Locations
- 47
- Primary Endpoint
- OS is defined as the length of time from date of randomization until the date of death from any cause
Overview
Brief Summary
- To compare overall survival (OS) of domvanalimab + zimberelimab + chemotherapy versus nivolumab + chemotherapy in participants with high programmed death ligand 1 (PD-L1) expression.
- To compare OS of domvanalimab + zimberelimab + chemotherapy versus nivolumab + chemotherapy in participants with positive PD-L1 expression.
- To compare OS of domvanalimab + zimberelimab + chemotherapy versus nivolumab + chemotherapy in all randomized participants.
Study Design
- Allocation
- Randomized
- Primary Purpose
- Overall Study
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
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-
- •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.
Outcomes
Primary Outcomes
OS is defined as the length of time from date of randomization until the date of death from any cause
OS is defined as the length of time from date of randomization until the date of death from any cause
Secondary Outcomes
- PFS is defined as the time from date of randomization until disease progression or death from any cause, whichever comes first, as measured per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the investigator
- Time to first symptom deterioration in the FACT-Ga gastric cancer subscale.
- 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 1.1
- Duration of response (DOR) is measured from the time of first confirmed 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.
- 5. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and any clinically meaningful trends in safety parameters
Investigators
Medical Director
Scientific
Arcus Biosciences Inc.
Study Sites (47)
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