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Trial Title:
Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma
NCT ID:
NCT05983237
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Temozolomide
Fluzoparib
Conditions: Keywords:
Homologous recombination (HR)
PARP inhibitor
anti PD-1 antibody
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fluzoparib Camrelizumab Temozolomide
Description:
Fluzoparib 50-150mg bid po, d1-21, q3w Camrelizumab 200mg iv, d1, q3w Temozolomide
50mg/m2-200mg/m2 d1-5,q3w
Arm group label:
Camre+Fluzo+TMZ
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.
Detailed description:
Treatment with PARP inhibitors could represent a novel opportunity to selectively kill a
subset of cancer cells with deficiencies in DNA repair pathways. Non-BRCA deficiencies in
homologous recombination DNA repair genes could also enhance tumor cell sensitivity to
PARP inhibitors. Therefore, PARP inhibitors are also selectively cytotoxic for cancer
cells with deficiencies in DNA repair proteins other than BRCA1 and BRCA2.
In melanoma, genetic HR mutation/ alterations are rather common. Retrospective data
showed that nearly18-40% of melanoma harbors a mutation in at least 1 of the HR genes in
their tumor. The commonly altered genes were ARID1A, FANCA, ATM, BRCA1, ATRX and BRCA2,
ATR, BRCA1 BRIP1 and SF3B1. These findings indicate that HR mutations / alterations are
frequently observed in metastatic melanoma, and they suggest that PARP inhibitors could
potentially be of a great clinical value in a substantial portion of the patients with
advanced melanoma.
In this clinical study, clinical efficacy of fluzoparib in combination with camrelizumab
and temozolomide will be evaluated by assessing an objective clinical response rate in
patients with advanced, metastatic melanoma with the homologous recombination (HR)
pathway gene mutation / alteration.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 31, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Jun Guo
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05983237
