Fluzoparib combined with camrelizumab and temozolomide for 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
This study is testing a new combination of three drugs to see if it can help people with advanced melanoma that has certain genetic changes.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | Camrelizumab, prednisone |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05983237 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with unresectable or metastatic stage III or IV melanoma and documented HR or SF3B1 mutations.
Not a fit: Patients who have previously been treated with a PARP inhibitor or have hypersensitivity to the study drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced melanoma who have specific genetic mutations.
How similar studies have performed: Other studies have shown promising results using PARP inhibitors in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing
- Beijing Cancer Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Jun Guo
- Email: guoj307@126.com
- Phone: 86-10-88121122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.