Randomized Phase III Trial of M-Folfirinox +/- Nivolumab vs. Folfox +/- Nivolumab for First Line Treatment of Metastatic HER-2 Negative Gastroesophageal Addenocarcinoma

Sponsor:

Alliance for Clinical Trials in Oncology

Sponsor Study ID:

A022102

CTO #:

103837

NCT Number:

NCT05677490

Phase:

III

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Esophagus; Stomach

Study Objectives:

To determine if overall survival (OS) is improved in patients who received mFOLFIRINOX +/- nivolumab in comparison to FOLFOX +/- nivolumab as first-line chemotherapy for metastatic gastroesophageal adenocarcinoma. To compare other indices of efficacy, including progression-free survival, objective response rates and duration of response between both treatment arms. To evaluate safety and tolerability associated with treatment in each of the treatment arms. To evaluate the proportion of patients receiving second line of therapy in both arms. To evaluate tolerability of the treatment in both arms using PRO-CTCAE

eConsent:

Not available

Study Documents:

Open Study Documents
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