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

Acral Melanoma Clinical Trial

Official title:

Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05789043
• Other study ID #: MA-MM-III-004
• Status: Recruiting
• Phase: Phase 3
• Start date: March 21, 2023
• Est. completion date: February 15, 2027

Study information

• Verified date: September 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: Jun Guo, Dr
• Phone: 010-88121122
• Email: guoj307[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: February 15, 2027
• Est. primary completion date: August 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acral Melanoma
• Melanoma

Intervention

Drug:
• camrelizumab+apatinib+TMZ
camrelizumab 200mg,q2w+apatinib 250mg,qd+TMZ 200mg/m2,day1-5/28
• camrelizumab+apatinib
camrelizumab 200mg,q2w+apatinib 250mg qd
• camrelizumab
camrelizumab 200mg,q2w

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival, PFS	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.	Within 2 years
Secondary	Overall Survival ,OS	OS will be defined as the time from randomization to death due to any cause.	Within 2 years
Secondary	ORR	The objective response rate will be assessed by RECIST 1.1	Within 2 years
Secondary	DCR	The disease control rate will be assessed by RECIST 1.1	Within 2 years
Secondary	Adverse Events (AEs)	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.	Within 2 years