NCT04622566

Lenvatinib and Pembrolizumab in Resectable Mucosal Melanoma

A Phase II Study of Neoadjuvant Lenvatinib and Pembrolizumab in Resectable Mucosal Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized ,single center clinical study which is designed to investigate whether combination of Pembrolizumab with Lenvatinib could improve pCR rate and consequent survival in resectable mucosal melanoma. All the eligible patients were assigned to receive Lenvatinib once a day (QD) for 6 weeks plus pembrolizumab on Day 1 of each 21-day cycle (Q3W) concurrently on days 1 and 22, followed by surgery and 18 cycles of Pembrolizumab 200mg q3w of adjuvant phase.

Detailed description

Mucosal melanoma is a rare type of melanoma in 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, and neoadjuvant therapy is still needed which can lead to improvements in outcomes by surgical resectability, local control and organ preservation. Immunotherapy has showed promising activity in advanced melanoma. However, PD-1 antibodies, both Pembrolizumab and Nivolumab, showed much poorer response to mucosal melanoma than to cutaneous melanoma. Pembrolizumab showed modest objective response rate (ORR, 13%) in advanced mucosal melanoma in Chinese population (NCT02628067). Recent study also demonstrated that neoadjuvant therapy with one dose of Pembrolizumab could lead to pathological complete response (pCR) or major response in nearly 30% of resectable advanced melanoma and pCR was 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 FDA for differentiated thyroid cancer, advanced renal cell carcinoma and hepatocellular carcinoma. It is hypothesized that neoadjuvant Pembrolizumab in combination with Lenvatinib could result in higher anti-tumor activity with lower toxicity and prolong RFS and OS in high-risk resectable mucosal melanoma. The study will assess the efficacy and safety of the combination Pembrolizumab and Lenvatinib as neoadjuvant treatment in resectable mucosal melanoma.

Conditions

• Mucosal Melanoma
• Neoadjuvant Treatment

Interventions

Type	Name	Description
DRUG	Lenvatinib, Pembrolizumab	After enrollment, patients receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for 6 weeks; Lenvatinib 20mg orally once daily for 6 weeks. Patients conduct surgery within 1-4 weeks after the last dose of Pembrolizumab and Lenvatinib. After complete surgery, Pembrolizumab will be as adjuvant treatment for up to 15 cycles, 200mg IV on day 1 of every 21 day-cycles.

Timeline

• Start date: 2020-12-30
• Primary completion: 2021-12-30
• Completion: 2023-12-30
• First posted: 2020-11-10
• Last updated: 2020-11-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study