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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Cancer Hospital & Institute

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • camrelizumab+apatinib+TMZ
  • camrelizumab+apatinib
  • camrelizumab

Treatment groups

140 Participants
are divided into 3 treatment groups