Advanced Upper Gastrointestinal Tract Adenocarcinoma
Conditions
Keywords
Domvanalimab, Zimberelimab, Nivolumab, Advanced upper gastrointestinal tract adenocarcinoma, Gastroesophageal junction cancer, Esophageal adenocarcinoma, Gastric cancer, Gastric adenocarcinoma
Brief 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.
Interventions
DRUGDomvanalimab
Intravenous (IV) Aqueous Solution
DRUGZimberelimab
IV Aqueous Solution
DRUGCapecitabine
Oral Tablets
DRUGFluorouracil
IV Aqueous Solution
DRUGLeucovorin
IV Aqueous Solution
DRUGOxaliplatin
IV Aqueous Solution
DRUGNivolumab
IV Aqueous Solution
Sponsors
Arcus Biosciences, Inc.
Gilead Sciences
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 status of 0-1. * At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Key
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 completion of neoadjuvant or adjuvant therapy. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | From date of randomization until date of death from any cause (Approximately 15 months)] |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | From date of randomization to date of the first documentation of disease progression or date of death from any cause, whichever comes first (Approximately 15 months) |
| Objective response rate (ORR) | Proportion of randomized participants who achieved a confirmed best overall response of complete response (CR) or partial response (PR) (Approximately 15 months) |
| Duration of response (DOR) | From the date of first confirmed response (CR or PR), until the date of first documented disease progression or date of death from any cause, whichever comes first (Approximately 15 months) |
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | From on or after the date of first dose of any study treatment to the date of last study treatment specific safety follow-up or date of initiation of subsequent systemic anti-cancer therapy, whichever occurs first (Approximately 15 months) |
| Time to first symptom deterioration in the FACT-Ga gastric cancer subscale. | From the date of randomization to change from baseline in subscale greater than or equal to the deterioration threshold, or death from any cause, whichever comes first (Approximately 15 months) |
Countries
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, United States
Contacts
STUDY_DIRECTORMedical Director
Arcus Biosciences
Outcome results
None listed