drugset / Trial / NCT07353073
A Prospective, Single-Arm, Phase II Clinical Study of Neoadjuvant Therapy With Pucotenlimab, Lenvatinib, and Temozolomide for Resectable Head and Neck Mucosal Melanoma (PLT-NAT-HNMM-II)
Phase 2
Not yet recruiting
30 enrolled
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
NaSingle-groupOpen-labelTreatment
Summary
This study aims to conduct a prospective clinical trial investigating the use of pucotenlimab in combination with lenvatinib and temozolomide as neoadjuvant and postoperative adjuvant therapy for resectable oral and head and neck mucosal melanoma. The primary objectives are to evaluate the safety and efficacy of this combination regimen in the neoadjuvant treatment of head and neck mucosal melanoma.
Timeline
- Start
- 2026-01-01
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 20 mg | — |
| Subject | Pucotenlimab | Monoclonal antibody | 3 mg/kg | — |
| Subject | Pucotenlimab | Monoclonal antibody | 200 mg | — |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | Oral |