NCT04462965 is a Phase 2 clinical trial of Toripalimab in Mucosal Melanoma, sponsored by Peking University Cancer Hospital & Institute.

Who is sponsoring NCT04462965?

NCT04462965 is sponsored by Peking University Cancer Hospital & Institute.

What drugs are being tested in NCT04462965?

Interventions in NCT04462965: Toripalimab, Temozolomide.

What condition does NCT04462965 study?

NCT04462965 studies Mucosal Melanoma.

Is NCT04462965 still recruiting?

NCT04462965 is currently status unknown. Last updated 25 January 2022.

Last reviewed 2022-01-25 · How we verify

NCT04462965

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Postoperative Adjuvant Treatment of Completely Resected Mucosal Melanoma Phase II Study

Status unknown Phase 2 Last updated 25 January 2022

What this trial tests

Phase 2 trial testing Toripalimab in Mucosal Melanoma in 294 participants. Status unknown.

Timeline

30 May 2020

Primary endpoint
30 November 2024

30 June 2025

Quick facts

Lead sponsor	Peking University Cancer Hospital & Institute
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	294
Start date	30 May 2020
Primary completion	30 November 2024
Estimated completion	30 June 2025
Sites	1 location across China

Drugs / interventions tested

Toripalimab (TORIPALIMAB) — full drug profile →
Temozolomide (temozolomide) — full drug profile →

Conditions studied

Mucosal Melanoma — all drugs for Mucosal Melanoma →

Sponsor

Peking University Cancer Hospital & Institute

Who can join

Adults 18 to 75, any sex, with Mucosal Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A mucosal melanoma postoperative adjuvant treatment of multicenter, randomized, double-blind, placebo-controlled phase II study, evaluation of mucosal melanoma patients accept completely resected, Toripalima Combined with Temozolomide and Cisplatin postoperative adjuvant therapy efficacy and safety

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Immunotherapy in Acral and Mucosal Melanoma: Current Status and Future Directions.
Mao L, Qi Z, Zhang L, Guo J, et al · · 2021 · cited 119× · PMID 34149718 · DOI 10.3389/fimmu.2021.680407
Vulvar Melanoma: Molecular Characteristics, Diagnosis, Surgical Management, and Medical Treatment.
Wohlmuth C, Wohlmuth-Wieser I. · · 2021 · cited 38× · PMID 34125416 · DOI 10.1007/s40257-021-00614-7
Mucosal Melanoma: Epidemiology, Clinical Features, and Treatment.
Sergi MC, Filoni E, Triggiano G, Cazzato G, et al · · 2023 · cited 29× · PMID 37773078 · DOI 10.1007/s11912-023-01453-x
Advances in immunotherapy for mucosal melanoma: harnessing immune checkpoint inhibitors for improved treatment outcomes.
Shan Z, Liu F. · · 2024 · cited 9× · PMID 39234260 · DOI 10.3389/fimmu.2024.1441410
Primary Mucosal Melanoma: Clinical Experience from a Single Italian Center.
Falcone R, Verkhovskaia S, Di Pietro FR, Poti G, et al · · 2024 · cited 5× · PMID 38275835 · DOI 10.3390/curroncol31010042
Management of primary anorectal mucosal melanoma during the COVID-19 pandemic.
Yan-Quiroz EF, Agreda-Castro FM, Diaz-Lozano L, Tenazoa-Villalobos R, et al · · 2023 · cited 1× · PMID 38414935 · DOI 10.3332/ecancer.2023.1610
Adjuvant short-course radiotherapy combined with chemotherapy and a PD-1 inhibitor for resected mucosal melanoma: study protocol for a single-arm, prospective, phase II trial.
Lv J, Shen L, Jiang X, Wu R, et al · · 2026 · PMID 41991257 · DOI 10.1136/bmjopen-2025-114414

Verify or expand the search:

Other trials of Toripalimab

Trials testing the same drug.

NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
NCT07423078 — Window of Opportunity in Preserving Laryngeal Function Trial · Phase 2 · recruiting
NCT07480733 — Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting
NCT07320963 — Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma. · Phase 1, PHASE2 · not yet recruiting
NCT07469956 — Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancre · Phase 2 · not yet recruiting

Other recruiting trials for Mucosal Melanoma

Currently open trials in the same condition.

NCT06319196 — Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma · Phase 2 · recruiting
NCT07400302 — Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery · Phase 2 · recruiting
NCT05111574 — Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery · Phase 2 · recruiting
NCT05086692 — A Beta-only IL-2 ImmunoTherapY Study · Phase 1, PHASE2 · recruiting
NCT04645680 — Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic · Phase 2 · active not recruiting

Other Peking University Cancer Hospital & Institute trials

Trials by the same sponsor.

NCT07527806 — Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Im · Phase 2 · not yet recruiting
NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
NCT07417241 — SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study · Phase 2 · not yet recruiting
NCT07470203 — Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer · not yet recruiting
NCT07394192 — Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-I · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04462965 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Peking University Cancer Hospital & Institute
Last refreshed: 25 January 2022

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/NCT04462965.

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