A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors

Summary

Assessment of the efficacy and safety of Regorafenib and Avelumab in patients with advanced or metastatic solid tumors (ten cohorts), once the Recommanded Phase II Dose (RP2D) has been determined (phase I trial). Assessement of the efficacy and safety of a low-dose of regorafenib (80mg/day) with avelumab in patients with advanced or metastatic colorectal tumors.

Timeline

Start

2018-05-04

Primary completion

2024-12-31

Completion

2025-12-31

Publications

• Toulmonde M, Guegan JP, Spalato-Ceruso M, Valentin T, Bahleda R, Peyraud F, Rey C, Kind M, Cantarel C, Bellera C, Vanhersecke L, Bessede A, Italiano A. Reshaping the tumor microenvironment of cold soft-tissue sarcomas with anti-angiogenics: a phase 2 trial of regorafenib combined with avelumab. Signal Transduct Target Ther. 2025 Jun 27;10(1):202. doi: 10.1038/s41392-025-02278-9.
• Cousin S, Guegan JP, Palmieri LJ, Metges JP, Pernot S, Bellera CA, Assenat E, Korakis I, Cassier PA, Hollebecque A, Cantarel C, Kind M, Soubeyran I, Sokol H, Vanhersecke L, Bessede A, Italiano A. Regorafenib plus avelumab in advanced gastroenteropancreatic neuroendocrine neoplasms: a phase 2 trial and correlative analysis. Nat Cancer. 2025 Apr;6(4):584-594. doi: 10.1038/s43018-025-00916-3. Epub 2025 Apr 9.
• Cousin S, Cantarel C, Guegan JP, Mazard T, Gomez-Roca C, Metges JP, Bellera C, Adenis A, Korakis I, Poureau PG, Bourcier K, Toulmonde M, Kind M, Rey C, Auzanneau C, Bessede A, Soubeyran I, Italiano A. Regorafenib-avelumab combination in patients with biliary tract cancer (REGOMUNE): a single-arm, open-label, phase II trial. Eur J Cancer. 2022 Feb;162:161-169. doi: 10.1016/j.ejca.2021.11.012. Epub 2022 Jan 5.
• Toulmonde M, Brahmi M, Giraud A, Chakiba C, Bessede A, Kind M, Toulza E, Pulido M, Albert S, Guegan JP, Cousin S, Mathoulin-Pelissier S, Perret R, Croce S, Blay JY, Ray-Coquard I, Floquet A, Italiano A. Trabectedin plus Durvalumab in Patients with Advanced Pretreated Soft Tissue Sarcoma and Ovarian Carcinoma (TRAMUNE): An Open-Label, Multicenter Phase Ib Study. Clin Cancer Res. 2022 May 2;28(9):1765-1772. doi: 10.1158/1078-0432.CCR-21-2258.

Drugs

Indications