Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma
- Sponsor
- Jun Guo
- Study ID
- NCT05983237
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fluzoparib Camrelizumab Temozolomide — DRUGFluzoparib 50-150mg bid po, d1-21, q3w Camrelizumab 200mg iv, d1, q3w Temozolomide 50mg/m2-200mg/m2 d1-5,q3w
Study Details
The purpose of this study is to evaluate how well fuzoparib in combination with camrelizumab and temozolomide works in treating patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration.
Key Dates
- Start date
- Aug 15, 2023
- Status verified
- Feb 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Camre+Fluzo+TMZThis arm will enroll patients who has advanced melanoma with a genetic HR mutation/ alteration .
Primary Outcome Measure
Objective Response Rate (ORR) [ Time Frame: 6 months ]
Central Contacts
- Jun Guo86-10-88121122
- Bin Lian86-10-88121122
Related Studies
- Evaluation for NCI Surgery Branch Clinical Research ProtocolsRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of MelanomaRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- Harvesting Cells for Experimental Cancer TreatmentsEnrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland
- Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch StudiesEnrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland