At a glance
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Avelumab and Cetuximab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer - The Phase II AVETUX- Colorectal Cancer (CRC) Trial.
In Brief
A Phase 2 clinical trial evaluating Avelumab for Metastatic Colorectal Cancer. Completed, enrolled 43 participants across 1 site.
Detailed Summary
AVETUX is a single arm multicentric phase II investigator initiated trial conducted by the Arbeitsgemeinschaft Internistische Onkologie (AIO) in 11 German sites in patients with previously untreated RAS/BRAF wildtype mCRC independent of MSI status.
Study Details
Timeline
Interventions
All eligible patients will receive cetuximab and mFOLFOX6 combined avelumab from the second cycle onwards. Cetuximab at a dose of 250 mg/m2 IV over 60 to 90 min (day 1 and 8) (first dose 400mg/m2) mFOLFOX6 (administration according to local standard) Oxaliplatin at a dose of 85 mg/m2 IV (day 1) 5-FU 400 mg/m2 IV bolus (day 1) LV at a dose of 400 mg/m2 iv (day 1) 5-FU at a dose of 2400 mg/m2 IV (day 1-3) Avelumab at a dose of 10mg/kg IV over 60 to 90 min (day 1 from cycle 2 onwards)