NCT05983237 Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma
| NCT ID | NCT05983237 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Jun Guo |
| Condition | Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-08-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2023-08-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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;
Contact & Investigator
Jun Guo
STUDY DIRECTOR
Peking University Cancer Hospital & Institute
Frequently Asked Questions
Who can join the NCT05983237 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05983237 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05983237 currently recruiting?
Yes, NCT05983237 is actively recruiting participants. Contact the research team at guoj307@126.com for enrollment information.
Where is the NCT05983237 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05983237 clinical trial?
NCT05983237 is sponsored by Jun Guo. The principal investigator is Jun Guo at Peking University Cancer Hospital & Institute. The trial plans to enroll 50 participants.
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