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- W2892235917 endingPage "TPS9605" @default.
- W2892235917 startingPage "TPS9605" @default.
- W2892235917 abstract "TPS9605 Background: Merkel cell carcinoma (MCC) is a rare and aggressive skin cancer. MCC with clinically detected lymph node (LN) metastases is associated with high risk of systemic recurrence despite initial surgical therapy and/or radiation therapy (RT). Adjuvant cytotoxic chemotherapy is not associated with overall survival benefit in stage III MCC and there is a strong unmet need for effective adjuvant systemic therapy. Clinical investigation of PD-1/PD-L1 blockade in patients with metastatic MCC is associated with remarkable improvement in clinical outcomes with response rates > 50% in a chemotherapy-naïve setting. This notable benefit from PD-1 blockade in stage IV MCC, along with the recent success with adjuvant PD-1 blockade in stage III melanoma, together provide strong rationale for investigating avelumab, an anti-PD-L1 antibody, for adjuvant systemic therapy in MCC patients with high risk of recurrence. Methods: The ADAM (Adjuvant Avelumab in Merkel) trial is an investigator-sponsored, phase 3, multi-center, double-blinded and placebo-controlled study. We plan to enroll 100 MCC patients with clinically or radiologically detected LN metastases treated definitively with surgery (with or without adjuvant RT). Patients will be randomized (1:1) to receive either avelumab or placebo administered IV at a dose of 10mg/kg every 15 days for the first 4 months, then once monthly for the next 4 months, and then once every 4 months. Treatment will end 2 years after starting the study drug, or upon recurrence of disease, unacceptable toxicity, or study withdrawal. The primary endpoint is relapse-free survival. Secondary endpoints include overall survival, disease-specific survival, distant metastasis-free survival, and safety and tolerability. Exploratory endpoints include tissue and blood-based biomarkers and AMERK (Anti-Merkel polyomavirus) serology as a recurrence predictor in a prospective, multi-center setting. The ADAM trial represents the first-ever phase 3 trial in MCC and is a major academic collaboration across several US cancer centers. Clinical trial information: NCT03271372." @default.
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- W2892235917 date "2018-05-20" @default.
- W2892235917 modified "2023-10-01" @default.
- W2892235917 title "ADAM trial: A multicenter, randomized, double-blinded, placebo-controlled, phase 3 trial of adjuvant avelumab (anti-PD-L1 antibody) in merkel cell carcinoma patients with clinically detected lymph node metastases; NCT03271372." @default.
- W2892235917 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.tps9605" @default.
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