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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,040
Intravenous (IV) Aqueous Solution
IV Aqueous Solution
Oral Tablets
IV Aqueous Solution
IV Aqueous Solution
IV Aqueous Solution
IV Aqueous Solution
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
Santa Monica, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Overall survival
Time frame: From date of randomization until date of death from any cause (Approximately 15 months)]
Progression-free survival (PFS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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)
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Fort Myers, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
Tallahassee, Florida, United States
Research Site
Louisville, Kentucky, United States
Research Site
Louisville, Kentucky, United States
...and 158 more locations