Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma
Phase 2
- Conditions
- Melanoma
- Interventions
- Registration Number
- NCT04397770
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Brief Summary
It is a single-center,exploratory clinical trial aimed to evaluate the objective response rate (ORR) of Camrelizumab combined with apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- age:18-75 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 SHR- 1210 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;
- Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
- Received a live vaccine within 4 weeks of 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Camre+Apa+TMZ SHR1210 - Camre+Apa+TMZ apatinib mesylate - Camre+Apa+TMZ Temozolomide Injection -
- Primary Outcome Measures
Name Time Method ORR Through study uncompletion, an average of 1 year Objective Response Rate
- Secondary Outcome Measures
Name Time Method