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• W2912145584 abstract "TPS731 Background: The immune system plays a crucial role in modulating response to monoclonal antibodies therapy in cancer. Novel immunecheckpoint inhibitors have demonstrated potent efficacy alone and in combinations with cytotoxic agents in several cancers. In this regard, avelumab in combination with cetuximab might be a relevant rechallenge strategy in RAS wild-type (WT) metastatic colorectal cancer (mCRC) patients treated in first-line with chemotherapy (CT) in combination with anti-EGFR drugs and who achieved a complete or partial response. Methods: CAVE Colon is a single arm, multi-center phase II study designed to evaluate the efficacy of avelumab and cetuximab in pre-treated RAS WT mCRC patients. Eligible patients: pathologically confirmed RAS WT mCRC treated with a first-line CT in combination with an anti-EGFR agent with a major response achieved (complete or partial), who have progressed to a second line therapy, and received no prior immunotherapy. Primary endpoint is overall survival, secondary endpoint are overall response rate according to RECIST 1.1, progression free survival and safety profile. The current study seeks to demonstrate a median OS of 11 months (alternative hypothesis) by the experimental combination for comparison with historical median OS 8.0 (null hypothesis) with standard third line treatments, which correspond to an improvement of OS at six months from 40% to 57%. It was estimated that it would be needed to enroll 66 patients to achieve a 80% power with a one-sided 5% level test. The accrual period will be 18 months and the total duration of the study will be 36 months. Considering a potential drop-out of approximately 15% of patients, a total of 75 patients will be recruited. Seven patients have been enrolled and started treatment to date (September 15, 2018) with avelumab 10 mg/kg q14 as a one-hour i.v. infusion and cetuximab at 400 mg/m 2 over two-hour and subsequently 250 mg/m 2 q 14 as one-hour i.v. infusion until disease progression or unacceptable toxicity. EudraCT number: 2017-004392-32. This study is partially supported by Merck KgA, Darmstadt, Germany. Results: N/A. Conclusions: N/A. Clinical trial information: EudraCT number: 2017-004392-32." @default.
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• W2912145584 date "2019-02-01" @default.
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• W2912145584 title "Phase II study of avelumab in combination with cetuximab in pre-treated RAS wild-type metastatic colorectal cancer patients: CAVE (cetuximab-avelumab) Colon." @default.
• W2912145584 doi "https://doi.org/10.1200/jco.2019.37.4_suppl.tps731" @default.
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