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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 trial testing Preoperatively, patients will receive 2 cycles of pucotenlimab (200 mg every 3 weeks, or 3 mg/kg every 3 weeks) combined with lenvatinib (20 mg once daily) and temozolomide (150 mg/m² orally once dail in Head and Neck Mucosal Melanomas in 30 participants. Not yet recruiting.
31 December 2027
Quick facts
| Lead sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 January 2026 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Preoperatively, patients will receive 2 cycles of pucotenlimab (200 mg every 3 weeks, or 3 mg/kg every 3 weeks) combined with lenvatinib (20 mg once daily) and temozolomide (150 mg/m² orally once dail
Conditions studied
- Head and Neck Mucosal Melanomas — all drugs for Head and Neck Mucosal Melanomas →
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Who can join
Adults 18 to 75, any sex, with Head and Neck Mucosal Melanomas. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07353073
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07353073 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Last refreshed: 20 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07353073.
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