Abstract 881TiP
Background
Mucosal melanoma is a rare type of melanoma in the Caucasian population and a dominate subtype in Asia, which generally carries a worse prognosis than cutaneous melanoma. Surgery remains the primary therapeutic intervention for mucosal melanoma. Pembrolizumab showed modest objective response rate (ORR, 13%) in advanced mucosal melanoma in the Chinese population (NCT02628067). Recent study has also demonstrated neoadjuvant therapy with pembrolizumab could lead to pathological response which associated with reduced risk of recurrence and improved survival. Lenvatinib is also a kinase inhibitor that inhibits the kinase activities of VEGFR1,2, 3, which has been approved by the FDA for differentiated thyroid cancer, advanced renal cell carcinoma and hepatocellular carcinoma. This trial hypothesize that neoadjuvant combination of pembrolizumab and lenvatinib may enhance anti-tumor activity and prolong RFS and OS in resectable mucosal melanoma.
Trial design
NEOplus(NCT04622566) is a single-arm, open-label phase 2 trial evaluating the efficacy and safety of neoadjuvant with lenvatinib and pembrolizumab in resectable mucosal melanoma. Newly diagnosed resectable mucosal melanoma patients without any previous anti-cancer treatment may be included. Twenty-six patients will be enrolled in this study and will received pembrolizumab (200mg IV, Q3W) in combination with lenvatinib (20mg QD) for 6 weeks before surgery. Pembrolizumab (200mg IV, Q3W) will be as adjuvant treatment for 15 cycles until the disease progresses or intolerable toxicity. The primary endpoint is complete pathologic response (pCR), which is defined as no residual tumor cells in tumor bed or lymph nodes. Secondary endpoints are pathologic response which include pCR, MPR and pPR (MPR was defined as less than 10% of residual viable tumor cells. pPR was defined as less than 50% residual viable tumor cells); relapse-free survival (RFS), overall survival (OS) and safety etc. Enrollment began in Oct 2021.
Clinical trial identification
NCT04622566.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Merck Sharp & Dohme Corp.
Disclosure
L. Si: Financial Interests, Personal, Invited Speaker: MSD, Roche, Novartis, Shanghai Junshi Biosciences, Oriengene. J. Guo: Financial Interests, Personal, Advisory Board: MSD, Roche, Pfizer, Bayer, Novartis, Simcere, Shanghai Junshi Bioscience, Oriengene. All other authors have declared no conflicts of interest.