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Endostar Plus Toripalimab as Adjuvant Therapy for Resectable Stage III-Oligometastatic Stage IV Cutaneous Melanoma

Clinical Stage IV Cutaneous Melanoma AJCC v8 Clinical Trial

Official title:
The Safety and Efficacy of Endostar Combined With Toripalimab as Postoperative Adjuvant Therapy for Resectable Stage III-Oligometastatic Stage IV Cutaneous Melanoma: A Prospective, Single-arm, Open-label, Phase II Clinical Study

Clinical Trial Summary

The goal of this clinical trial is to evaluate the efficacy and safety of Endostar combined with Toripalimab in the adjuvant treatment of resectable stage III-oligometastatic stage IV melanoma, and to find effective biomarkers of efficacy based on tumor paraffin tissue specimens and peripheral blood. The main questions it aims to answer are: - The efficacy and safety of the combination treatment regimen; - Finding suitable biomarkers can refine the patients with effective treatment After a series of evaluation, if the participants meet the inclusion and exclusion criteria and are evaluated by the investigator, they will formally enter the study observation period and receive the following treatments Endostar: The dose of 210 mg (14 vials) is administered by intravenous pump from Day 1 to Day 3 of each course, every 4 weeks as a cycle, until disease recurrence, metastasis or intolerable toxicity, and up to 6 courses of administration. Toripalimab: 3 mg/kg by intravenous drip every 2 weeks (Day 1 and Day 15 of each cycle) in a 4-week cycle until disease recurrence, metastasis, or intolerable toxicity for up to 1 year (about 13 cycles).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Melanoma
  • Skin Neoplasms
Clinical Trial Details
NCT number NCT05907512
Study type Interventional
Source Fudan University
Contact Chunmeng Wang, M.D.
Phone +86 1387197 6170
Email cmwang1975@163.com
Status Recruiting
Phase Phase 2
Start date April 1, 2020
Completion date August 31, 2024
View Details
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