Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jun Guo
- Trial code
- NCT05983237
- Record updated
- 5 March 2025
- Original description
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.Read full original descriptionShow less
Phase Ib Study of Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma With Homologous Recombination (HR) Mutation ，a Single-center Open-label Exploratory Clinical Trial
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.
Inclusion: Histologically confirmed diagnosis of unresectable or metastatic stage III or IV melanoma; Must have genetic HR and/or SF3B1 mutation/ alteration; Must have measurable disease based on RECIST 1.1; Must have an ECOG performance status of 0 to 1; Must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline; Anticipated overall survival more than 3 months; Male and no pregnant female, able to adapt birth control methods during treatment.
Exclusion: Previously treated with a PARP inhibitor; Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; Patients with a history of other (including unknown primary) malignancies within 5 years prior to the first dose of trial treatment; Hypersensitivity to Fluzoparib or Camrelizumab or Temozolomide.