NCT04180995

Toripalimab in Combination With Axitinib in Patients With Localized Mucosal Melanoma

Status unknown Phase 2 Last updated 31 January 2022

What this trial tests

Phase 2 trial testing TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®) in Mucosal Melanoma in 30 participants. Status unknown.

Timeline

6 August 2019

Primary endpoint
6 July 2022

30 December 2022

Quick facts

Lead sponsor	Peking University Cancer Hospital & Institute
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	6 August 2019
Primary completion	6 July 2022
Estimated completion	30 December 2022
Sites	1 location across China

Drugs / interventions tested

• TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®) — 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

This study is one monocentric, single-arm, open, phase Ⅱ clinical study to evaluate the safety and efficacy of Toripalimab monoclonal injection (Tuo Yi) combined with axitinib tablet (Inlyta®) as neoadjuvant therapy for localized mucosal melanoma.

Primary objective: To evaluate pathological response (pCR+pPR) rate of Toripalimab combined with axitinib as neoadjuvant therapy for localized mucosal melanoma.

The subjects will receive Toripalimab and Axitinib combined therapy after enrollment, and receive operation 2 weeks after the last dose of Axitinib. Toripalimab will be given for a total of 4 cycles (8 weeks), whereas Axitinib will be given for a total of 8 weeks.The subjects can receive Toripalimab for up to one year after the operation.

Publications & conference data

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

1. 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
2. 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
3. RTK Inhibitors in Melanoma: From Bench to Bedside.
   Sabbah M, Najem A, Krayem M, Awada A, et al · · 2021 · cited 38× · PMID 33918490 · DOI 10.3390/cancers13071685
4. 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
5. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
   Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
6. Molecular Profiling and Novel Therapeutic Strategies for Mucosal Melanoma: A Comprehensive Review.
   Indini A, Roila F, Grossi F, Massi D, et al · · 2021 · cited 19× · PMID 35008570 · DOI 10.3390/ijms23010147
7. Shaping the Future of Immunotherapy Targets and Biomarkers in Melanoma and Non-Melanoma Cutaneous Cancers.
   Spiliopoulou P, Vornicova O, Genta S, Spreafico A. · · 2023 · cited 10× · PMID 36674809 · DOI 10.3390/ijms24021294
8. 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