NCT06041724

Envafolimab Combined With Recombinant Human Endostatin and First-line Chemotherapy Treat of Advanced Mucosal Melanoma

Status unknown Phase 2 Last updated 18 September 2023

What this trial tests

Phase 2 trial testing Envafolimab combined with recombinant human endostatin and first-line chemotherapy in Advanced Mucosal Melanoma in 46 participants. Status unknown.

Timeline

18 September 2023

Primary endpoint
18 September 2025

18 March 2026

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	18 September 2023
Primary completion	18 September 2025
Estimated completion	18 March 2026

Drugs / interventions tested

• Envafolimab combined with recombinant human endostatin and first-line chemotherapy — full drug profile →

Conditions studied

• Advanced Mucosal Melanoma — all drugs for Advanced Mucosal Melanoma →

Sponsor

Fudan University

Who can join

18 and older, any sex, with Advanced Mucosal Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase II, open, single-center study to explore the efficacy and safety of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin in the treatment of mucosal melanin. At the same time, the tissue and peripheral blood samples of the patients were taken for the determination of PD-L1 expression, ctDNA and other biomarkers and the results were analyzed to find the predictive factors of prognosis or curative effect. Patients with advanced mucosal melanoma who met the inclusion criteria but did not meet the exclusion criteria were enrolled in this study and received 6 cycles of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin. Patients without progression were then maintained with Envafolimab combined with recombinant human endostatin until disease progression, intolerable adverse reactions, patient death or withdrawal of informed consent. The longest administration time of recombinant human endostatin was no more than 1 year, and that of Envafolimab was not more than 2 years. The efficacy was evaluated for the first time at 6 weeks, every 6 weeks for the following year, and then every 12 weeks until the end of progress or treatment. The examination method was consistent with the baseline; it was expected to be included in the group for 18 months, and clinical observation until disease progression and patient death.

Publications & conference data

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

1. 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
2. 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
3. Advanced Mucosal Melanoma Therapies: Current Status and Future Directions.
   Zhang Y, Zhao D, Wu D. · · 2026 · PMID 41944928 · DOI 10.1007/s11864-025-01372-y