Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05983237
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-14
First Post:
2023-07-11
Brief Title:
Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma
Sponsor:
Jun Guo
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None