Randomized Phase III Trial of mFOLFIRINOX +/- Nivolumab vs. FOLFOX +/- Nivolumab for First-Line Treatment of Metastatic HER2-Negative Gastroesophageal Adenocarcinoma
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Krishnan, Mridula
Contact Information:
Jessica Delaney
jessdelaney@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05677490?term=NCT05677490&rank=1
Summary
2.1 Primary objective
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.
2.2 Secondary objective(s)
2.2.1 To compare other indices of efficacy, including progression-free survival, objective response rates and duration of response between both treatment arms
2.2.2 To evaluate safety and tolerability associated with treatment in each of the treatment arms
2.2.3 To evaluate the proportion of patients receiving second line of therapy in both arms
2.2.4 To evaluate tolerability of the treatment in both arms using PRO-CTCAE
2.3 Exploratory objective(s)
2.3.1 Exploratory correlative markers will also be measured and evaluated within and between arms to better assess mechanisms and prognostic impact of markers on impact. These will include baseline PD-L1 CPS and cfDNA before and after treatment.
2.3.2 To evaluate and assess the feasibility and compliance associated with not centrally collecting perceived attribution of protocol treatment to reported adverse events.