MODUL cohort 2: an adaptable, randomized, signal-seeking trial of fluoropyrimidine plus bevacizumab with or without atezolizumab maintenance therapy for BRAF^wt metastatic colorectal cancer.

ABSTRACT:

Background

MODUL is an adaptable, signal-seeking trial designed to test novel agents in predefined patient subgroups in first-line metastatic colorectal cancer (mCRC).

Patients and methods

Patients with measurable, unresectable, previously untreated mCRC received induction with ≤8 cycles of FOLFOX + bevacizumab followed by randomization to maintenance treatment comprising control [fluoropyrimidine (FP)/bevacizumab: 5-fluorouracil 1600-2400 mg/m² 46-h intravenous (i.v.) infusion day 1 q2 weeks plus leucovorin 400 mg/m² 2-h infusion i.v. day 1 q2 weeks or capecitabine 1000 mg/m² b.i.d. orally days 1-14 every 21 days; bevacizumab 5 mg/kg 15-30-min i.v. infusion q2 weeks] or experimental treatment in one of four biomarker-driven cohorts. In patie

SUBMITTER: Tabernero J 

PROVIDER: S-EPMC9588902 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature