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

Peking University Cancer Hospital & Institute

Status and phase: Enrolling; Phase 3

Conditions: Acral Melanoma

Treatments: Drug: camrelizumab+apatinib; Drug: camrelizumab+apatinib+TMZ; Drug: camrelizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05789043

MA-MM-III-004

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 3 patient groups

Three-drug arm

Experimental group

Treatment:

Drug: camrelizumab+apatinib+TMZ

Two-drug arm

Active Comparator group

Treatment:

Drug: camrelizumab+apatinib

single-drug arm

Active Comparator group

Treatment:

Drug: camrelizumab