Ignite Creation Date:
2024-05-06 @ 4:26 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04985721
Status:
RECRUITING
Last Update Posted:
2023-03-15
First Post:
2021-06-28
Brief Title:
A Trial of Pamiparib With Tislelizumab in Patients With Advanced Tumours With Homologous Recombination Repair Defects
Sponsor:
Peter MacCallum Cancer Centre Australia
Organization:
Peter MacCallum Cancer Centre Australia
Study Overview
Official Title:
An Open Label Signal Seeking Translational Phase II Trial of Pamiparib in Combination With Tislelizumab in Patients With Advanced Tumours With Homologous Recombination Repair Defects
Status:
RECRUITING
Status Verified Date:
2023-03
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:
IMPARP-HRD
Brief Summary:
This study will describe the efficacy of pamiparib in combination with tislelizumab in patients with advanced tumours harbouring molecular profiles consistent with homologous recombination deficiency HRD agnostic of tumour origin A tumour-agnostic approach has been adopted in this study due to the broad activity of PARP inhibitors across multiple tumour types In addition response to PARP inhibitors has been demonstrated in patients with genomic features associated with HRD even in the absence of germline BRCA1 or BRCA2 mutations These results suggest that the presence of HRD itself is the key predictive biomarker for PARP inhibitor efficacy This paves the way for a precision-oncology tumour-agnostic approach to patient selection for treatment rather than the traditional tumour site-of-origin basis for which the current PARP inhibitor approvals exist To investigate this cohort A of this study includes patients with genomic features of HRD but without a germline BRCA1 or BRCA2 mutation Demonstration of clinical efficacy in this cohort will provide strong support to the tumour-agnostic precision-oncology approach for patient selection for PARP inhibitor or PARP inhibitor combination treatment This forms the primary objective of the study The study will consist of two cohorts broadly cohort A - patients without a pathogenic BRCA1 or BRCA2 mutation but with other germline or somatic mutations in other HRD genes cohort B- patients with a pathogenic BRCA1 or BRCA2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None