Clinical Trials
Sponsor:
Sponsor Study ID:
Study Title:
Randomized Phase III Trial of M-Folfirinox +/- Nivolumab vs. Folfox +/- Nivolumab for First Line Treatment of Metastatic HER-2 Negtive Gastroesophageal Addenocarcinoma
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
Study Documents
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