Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma

Phase 3

Recruiting

• Conditions: Acral Melanoma
• Interventions: Drug: camrelizumab+apatinib; Drug: camrelizumab+apatinib+TMZ; Drug: camrelizumab

• Registration Number: NCT05789043
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-16
• Study Start: 2023-03-21
• Study First Posted: 2023-03-29
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06
• Primary Completion: 2026-08-15
• Study Completion: 2027-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• age:≥18 years, male or female.
• Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
• Has not received any systematic anti-tumor drug treatment.
• Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
• ECOG 0-1.
• Adequate organ function.
• Life expectancy of greater than 12 weeks.
• Patient has given written informed consent.

Exclusion Criteria

• Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
• Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation.
• Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
• Subjects with any active autoimmune disease or history of autoimmune disease Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
• Received a live vaccine within 4 weeks before the first dose of study medication.
• Pregnancy or breast feeding.
• Decision of unsuitableness by principal investigator or physician-in charge.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two-drug arm	camrelizumab+apatinib	-
Three-drug arm	camrelizumab+apatinib+TMZ	-
single-drug arm	camrelizumab	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival, PFS	Within 2 years	PFS was defined as the time from randomization to progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
ORR	Within 2 years	The objective response rate will be assessed by RECIST 1.1
Overall Survival ,OS	Within 2 years	OS will be defined as the time from randomization to death due to any cause.
Adverse Events (AEs)	Within 2 years	An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment.
DCR	Within 2 years	The disease control rate will be assessed by RECIST 1.1

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China