Avelumab Plus Cetuximab in Pre-treated RAS Wild Type Metastatic Colorectal Cancer

Summary

This is a non-profit phase II, open-label, single-arm study of cetuximab plus avelumab in patients with RAS WT mCRC treated in first line with chemotherapy in combination with an anti- EGFR drug that have had a clinical benefit (complete or partial response) from treatment.

Timeline

Start

2018-08-10

Primary completion

2021-11-14

Completion

2021-11-14

Outcome

Met primary endpoint

paper The study met the primary end point, with median OS (mOS) of 11.6 months (95% CI, 8.4-14.8 months). PMID 34382998 ↗

Publications

• Ciardiello D, Martinelli E, Troiani T, Mauri G, Rossini D, Martini G, Napolitano S, Famiglietti V, Del Tufo S, Masi G, Santini D, Avallone A, Pietrantonio F, Lonardi S, Di Maio M, Zampino MG, Fazio N, Bardelli A, Siena S, Cremolini C, Sartore-Bianchi A, Ciardiello F. Anti-EGFR Rechallenge in Patients With Refractory ctDNA RAS/BRAF wt Metastatic Colorectal Cancer: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Apr 1;7(4):e245635. doi: 10.1001/jamanetworkopen.2024.5635.
• Martini G, Ciardiello D, Famiglietti V, Rossini D, Antoniotti C, Troiani T, Napolitano S, Esposito L, Latiano TP, Maiello E, Del Re M, Lonardi S, Aprile G, Santini D, Masi G, Avallone A, Normanno N, Pietrantonio F, Pinto C, Ciardiello F, Cremolini C, Martinelli E. Cetuximab as third-line rechallenge plus either irinotecan or avelumab is an effective treatment in metastatic colorectal cancer patients with baseline plasma RAS/BRAF wild-type circulating tumor DNA: Individual patient data pooled analysis of CRICKET and CAVE trials. Cancer Med. 2023 Apr;12(8):9392-9400. doi: 10.1002/cam4.5699. Epub 2023 Mar 7.
• Martinelli E, Martini G, Famiglietti V, Troiani T, Napolitano S, Pietrantonio F, Ciardiello D, Terminiello M, Borrelli C, Vitiello PP, De Braud F, Morano F, Avallone A, Normanno N, Nappi A, Maiello E, Latiano T, Falcone A, Cremolini C, Rossini D, Santabarbara G, Pinto C, Santini D, Cardone C, Zanaletti N, Di Liello A, Renato D, Esposito L, Marrone F, Ciardiello F. Cetuximab Rechallenge Plus Avelumab in Pretreated Patients With RAS Wild-type Metastatic Colorectal Cancer: The Phase 2 Single-Arm Clinical CAVE Trial. JAMA Oncol. 2021 Oct 1;7(10):1529-1535. doi: 10.1001/jamaoncol.2021.2915.

Drugs

Indications