Metastatic Colorectal Cancer Clinical Trial
Official title:
Avelumab and Cetuximab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer - The Phase II AVETUX- Colorectal Cancer (CRC) Trial.
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.
The primary clinical objective is to determine the efficacy of a standard 1st line regimen (FOLFOX and cetuximab) in patients with RAS/v-Raf murine sarcoma viral oncogene homolog B (BRAF) wildtype, Microsatellite Instability (MSI) or icrosatellite Stability (MSS) MCRC with avelumab in terms of progression free survival rate after 12 months (acc. to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1). The main secondary objective is to determine safety and tolerability, according to NCI Common Terminology Criteria for Adverse Events (CTCAE v4.03) and to the obtained data on vital signs, clinical parameters (oxygen saturation) and feasibility of the regimen. Further secondary objectives are to determine the efficacy of the experimental regimen in terms of objective response rate (acc. to RECIST v1.1 and irRECIST), and overall survival, to correlate clonal dynamics (RAS/EGFR subclones) with immune response signature to determine control of mutant subclones by the combination of anti-Epidermal growth factor receptor (EGFR) with anti-PD-L1and PD-L1 staining (and MSI status) with efficacy. ;
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