Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma
- Sponsor
- Peking University Cancer Hospital & Institute
- Study ID
- NCT05789043
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Acral Melanoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- camrelizumab+apatinib+TMZ — DRUGcamrelizumab 200mg,q2w+apatinib 250mg,qd+TMZ 200mg/m2,day1-5/28
- camrelizumab+apatinib — DRUGcamrelizumab 200mg,q2w+apatinib 250mg qd
- camrelizumab — DRUGcamrelizumab 200mg,q2w
Study Details
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.
Key Dates
- Start date
- Mar 21, 2023
- Status verified
- Sep 2023
- Primary completion
- Aug 15, 2026
- Completion
- Feb 15, 2027
Study Design
- Enrollment
- 140 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Three-drug arm
- Active Comparator: Two-drug arm
- Active Comparator: single-drug arm
Primary Outcome Measure
Progression Free Survival, PFS [ Time Frame: Within 2 years ]
Central Contacts
- Jun Guo, Dr010-88121122
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