drugset / Trial / NCT03174405
Avelumab and Cetuximab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer - The Phase II AVETUX-CRC Trial.
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-07-17
- Primary completion
- 2020-07-16
- Completion
- 2021-07-16
Publications
- Tintelnot J, Ristow I, Sauer M, Simnica D, Schultheiss C, Scholz R, Goekkurt E, von Wenserski L, Willscher E, Paschold L, Lorenzen S, Riera-Knorrenschild J, Depenbusch R, Ettrich TJ, Dorfel S, Al-Batran SE, Karthaus M, Pelzer U, Hinke A, Bauer M, Massa C, Seliger B, Wickenhauser C, Bokemeyer C, Hegewisch-Becker S, Binder M, Stein A. Translational analysis and final efficacy of the AVETUX trial - Avelumab, cetuximab and FOLFOX in metastatic colorectal cancer. Front Oncol. 2022 Dec 20;12:993611. doi: 10.3389/fonc.2022.993611. eCollection 2022.
- Stein A, Simnica D, Schultheiss C, Scholz R, Tintelnot J, Gokkurt E, von Wenserski L, Willscher E, Paschold L, Sauer M, Lorenzen S, Riera-Knorrenschild J, Depenbusch R, Ettrich TJ, Dorfel S, Al-Batran SE, Karthaus M, Pelzer U, Waberer L, Hinke A, Bauer M, Massa C, Seliger B, Wickenhauser C, Bokemeyer C, Hegewisch-Becker S, Binder M. PD-L1 targeting and subclonal immune escape mediated by PD-L1 mutations in metastatic colorectal cancer. J Immunother Cancer. 2021 Jul;9(7):e002844. doi: 10.1136/jitc-2021-002844.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Background | LV | Unknown | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |