Phase II study of avelumab in combination with cetuximab in pre-treated RAS wild-type metastatic colorectal cancer patients: CAVE (cetuximab-avelumab) Colon.

• DOI: 10.1200/jco.2019.37.4_suppl.tps731
• Publication Date: 2019-01-29T23:13:19Z
• Authors: Teresa Troiani; Erika Martinelli; Davide Ciardiello; Nicoletta Zanaletti; Claudia Cardone; Carola Borrelli; Antonio Avallone; Alfredo Falcone; Evaristo Maiello; Roberto Bordonaro; Daniele Santini; Carlo Garufi; Filippo G. De Braud; Carmine Pinto; Cesare Gridelli; Fortunato Ciardiello
• Keywords: Avelumab; Clinical endpoint; Panitumumab

TPS731 Background: The immune system plays a crucial role in modulating response to monoclonal antibodies therapy cancer. Novel immunecheckpoint inhibitors have demonstrated potent efficacy alone and combinations with cytotoxic agents several cancers. In this regard, avelumab combination cetuximab might be relevant rechallenge strategy RAS wild-type (WT) metastatic colorectal cancer (mCRC) patients treated first-line chemotherapy (CT) anti-EGFR drugs who achieved complete or partial response. Methods: CAVE Colon is single arm, multi-center phase II study designed evaluate the of pre-treated WT mCRC patients. Eligible patients: pathologically confirmed CT an agent major (complete partial), progressed second line therapy, received no prior immunotherapy. Primary endpoint overall survival, secondary are rate according RECIST 1.1, progression free survival safety profile. current seeks demonstrate median OS 11 months (alternative hypothesis) by experimental for comparison historical 8.0 (null standard third treatments, which correspond improvement at six from 40% 57%. It was estimated that it would needed enroll 66 achieve 80% power one-sided 5% level test. accrual period will 18 total duration 36 months. Considering potential drop-out approximately 15% patients, 75 recruited. Seven been enrolled started treatment date (September 15, 2018) 10 mg/kg q14 as one-hour i.v. infusion 400 mg/m 2 over two-hour subsequently 250 q 14 until disease unacceptable toxicity. EudraCT number: 2017-004392-32. This partially supported Merck KgA, Darmstadt, Germany. Results: N/A. Conclusions: Clinical trial information: