Last updated: September 4, 2023
Sponsor: Peking University Cancer Hospital & Institute
Overall Status: Active - Recruiting
Phase
3
Condition
Melanoma
Treatment
camrelizumab
camrelizumab+apatinib+TMZ
camrelizumab+apatinib
Clinical Study ID
NCT05789043
MA-MM-III-004
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- age:≥18 years, male or female.
- Histopathologically confirmed recurrence, inoperable resection or metastatic acralmelanoma (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
Exclusion Criteria:
- Patients who have or are currently undergoing additional chemotherapy, radiationtherapy, targeted therapy or immunotherapy.
- Known history of hypersensitivity to macromolecular protein preparation or anycomponents of the drug formulation.
- Subjects before or at the same time with other malignant tumors (except which hascured skin basal cell carcinoma and cervical carcinoma in situ);
- Subjects with any active autoimmune disease or history of autoimmune diseaseUncontrolled clinically significant heart disease, including but not limited to thefollowing: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardialinfarction within the past 1 year; (4) clinically significant supraventriculararrhythmia 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.
Study Design
Total Participants: 140
Treatment Group(s): 3
Primary Treatment: camrelizumab
Phase: 3
Study Start date:
March 21, 2023
Estimated Completion Date:
February 15, 2027
Connect with a study center
Beijing Cancer Hospital
Beijing,
ChinaActive - Recruiting
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