Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma

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 recombination (HR) pathway gene mutation / alteration.

Eligibility

Inclusion Criteria:

1. Histologically confirmed diagnosis of unresectable or metastatic stage III or IV melanoma;
2. Must have genetic HR and/or SF3B1 mutation/ alteration;
3. Must have measurable disease based on RECIST 1.1;
4. Must have an ECOG performance status of 0 to 1;
5. Must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline;
6. Anticipated overall survival more than 3 months;
7. Male and no pregnant female, able to adapt birth control methods during treatment.

Exclusion Criteria:

1. Previously treated with a PARP inhibitor;
2. Hypersensitivity to Fluzoparib or Camrelizumab or Temozolomide;
3. 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;
4. 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;
5. Patients with a history of other (including unknown primary) malignancies within 5 years prior to the first dose of trial treatment;

Conditions2

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