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

Conditions

Esophageal or Gastric Cancer, Metastatic Esophageal or Gastric Cancer

Brief summary

OS is defined as the length of time from date of randomization until the date of death from any cause

Detailed description

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

Related papers

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Interventions

DRUGDOMVANALIMAB

DRUGCALCIUM FOLINATE

DRUGFLUOROURACIL

DRUGOXALIPLATIN

DRUGCAPECITABINE

DRUGZimberelimab

DRUGNIVOLUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
OS is defined as the length of time from date of randomization until the date of death from any cause	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

France, Greece, Hungary, Italy, Lithuania, Poland, Portugal, Romania, Spain

Outcome results

None listed