RecruitingPhase 3NCT05789043

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

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

Sponsor

Peking University Cancer Hospital & Institute

Enrollment

140 participants

Start Date

Mar 21, 2023

Study Type

INTERVENTIONAL

Conditions

Acral Melanoma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria7

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.