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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-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 You should be able to carry out daily activities with 0 level of ability (ECOG 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. Who Should NOT Join This Trial: 1. Previously treated with a PARP inhibitor; 2. Hypersensitivity to Fluzoparib or Camrelizumab or Temozolomide; 3. Has a diagnosis of weakened immune system 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 weakened immune system 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; Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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;

Treatments Being Tested

DRUG

Fluzoparib Camrelizumab Temozolomide

Fluzoparib 50-150mg bid po, d1-21, q3w Camrelizumab 200mg iv, d1, q3w Temozolomide 50mg/m2-200mg/m2 d1-5,q3w

Locations (1)

Beijing Cancer Hospital
Beijing, China