Status:
RECRUITING
Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma
Lead Sponsor:
Jun Guo
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 recombin...
Detailed Description
Treatment with PARP inhibitors could represent a novel opportunity to selectively kill a subset of cancer cells with deficiencies in DNA repair pathways. Non-BRCA deficiencies in homologous recombinat...
Eligibility Criteria
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;
- Hypersensitivity to Fluzoparib or Camrelizumab or Temozolomide;
- 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;
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05983237
Start Date
August 15 2023
End Date
December 31 2027
Last Update
March 5 2025
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, China