NCT07501104

Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma

A Single-Arm, Single-Center, Phase II Exploratory Study of Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma（TRIUMPH-AM）

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, single-center, Phase II exploratory clinical study evaluating the efficacy, safety, and tolerability of neoadjuvant pucotenlimab combined with lenvatinib and temozolomide in patients with resectable Stage IIB/III acral melanoma. After providing written informed consent, eligible subjects will receive neoadjuvant combination therapy consisting of pucotenlimab, lenvatinib, and temozolomide, with each treatment cycle lasting 3 weeks. Surgical resection will be performed after 3 cycles of treatment. Postoperative adjuvant therapy will be determined based on the pathological results of the surgical specimens. Subjects who do not achieve a major pathological response (MPR) will receive pucotenlimab maintenance therapy for a total of 1 year, while subjects who achieve an MPR will be exempt from adjuvant therapy. Treatment will continue until the completion of adjuvant therapy, disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or discontinuation determined by the investigator, whichever occurs first.

Conditions

• Melanoma (Skin Cancer)

Interventions

Type	Name	Description
DRUG	Neoadjuvant Pucotenlimab+Lenvatinib+Temozolomide	Pucotenlimab: Administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle. Temozolomide: Administered orally at a dose of 200 mg/m\^2 once daily on Days 1 to 5 of each 21-day cycle. Lenvatinib: Administered orally once daily at a dose of 8 mg for patients weighing \< 60 kg, or 12 mg for patients weighing ≥ 60 kg.

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2026-03-30
• Last updated: 2026-03-30