NCT05983237RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 5 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 11 Jul 2023
- Start date
- 15 Aug 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Jun Guo
- Diseases
- Melanoma
- NCT number
- NCT05983237
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 50
- From 15 Aug 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously treated with a PARP inhibitor;
- 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;
Other illness
- Hypersensitivity to Fluzoparib or Camrelizumab or Temozolomide;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.