Fluzoparib combined with camrelizumab and temozolomide for advanced melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of fluzoparib, a PARP inhibitor, in combination with camrelizumab and temozolomide for treating patients with advanced metastatic melanoma that has specific genetic mutations in the homologous recombination (HR) pathway. The approach aims to selectively target cancer cells with deficiencies in DNA repair mechanisms, which are common in melanoma. The study will assess the clinical response rate in participants with these genetic alterations, providing insights into a potentially novel treatment strategy.

Why it matters

Who can join: the full rules

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;

Where it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Jun Guo
• Email: guoj307@126.com
• Phone: 86-10-88121122

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.