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

NCT05907512 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-06-22

No results posted yet for this study

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).

Conditions

  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8

Interventions

DRUG

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.

DRUG

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).

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2024-08-01
Completion
2024-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05907512 on ClinicalTrials.gov