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A Study of QL1706 Combined With OH2 Injection in Perioperative Treatment of Stage III Resectable Acral Melanoma

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This is a prospective, multicenter, open-label, 1:1 randomized phase II trial enrolling 76 patients with AJCC stage III surgically resectable acral melanoma. Arm A receives neoadjuvant combination of intratumoral OH2 oncolytic HSV2 plus IV QL1706 (Iparomlimab and Tuvonralimab Injection) for 6 q2w cycles before radical surgery, followed by stratified QL1706 adjuvant therapy. Arm B undergoes upfront radical surgery followed by single-agent QL1706 adjuvant therapy for up to 1 year. The primary endpoint is 2-year EFS rate. Secondary endpoints include pathologic response, RFS, OS, and overall safety profile. All patients receive regular imaging follow-up up to 5 years post-surgery.
Trial Details
NCT Number NCT07854522
Lead Sponsor Peking University Cancer Hospital & Institute
Collaborators: Qilu Pharmaceutical Co., Ltd.
Conditions
(from sponsor)
Melanoma, Acral Melanoma
Related terms Melanoma
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov