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New treatment option for Melanoma
Official title Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma
ClinicalTrials.gov ID: NCT05983237
What this study is testing
What is Fluzoparib Camrelizumab Temozolomide?
Fluzoparib Camrelizumab Temozolomide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- Previously treated with a PARP inhibitor;
- Hypersensitivity to Fluzoparib or Camrelizumab or Temozolomide;
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or...
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or...
- Patients with a history of other (including unknown primary) malignancies within 5 years prior to the first dose of trial treatment;
See the full eligibility criteria
- 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.
- Previously treated with a PARP inhibitor;
- Hypersensitivity to Fluzoparib or Camrelizumab or Temozolomide;
- 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...
- 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...
- Patients with a history of other (including unknown primary) malignancies within 5 years prior to the first dose of trial treatment;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.