Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05659914
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2022-11-22
Brief Title:
Olaparib and Durvalumab MEDI4736 in Patients with Metastatic Pancreatic Cancer and DNA Damage Repair Genes Alterations
Sponsor:
Spanish Cooperative Group for the Treatment of Digestive Tumours TTD
Organization:
Spanish Cooperative Group for the Treatment of Digestive Tumours TTD
Study Overview
Official Title:
Olaparib and Durvalumab MEDI4736 in Patients with Metastatic Pancreatic Cancer and DNA Damage Repair Genes Alterations
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
Patients with metastatic pancreatic cancer and germline mutation in BRCA have benefit of therapy with PARP inhibitors In addition some studies have demonstrated that PDL-1 inhibitors synergize therapeutically with PARP inhibitors in tumours with homologous repair deficiency
Our hypothesis is that those patients with alterations in DNA damage repair genes somatic and germline BRCA1 BRCA2 PALB2 RAD51C RAD51D and other functional DDR genes and who have benefit from platinum based therapy in first line might obtain an increased therapeutic effect with the combination of olaparib and durvalumab
This is an open-label single-arm multicentric phase II clinical trial of a combination of durvalumab and olaparib in patients with metastatic pancreatic cancer with alterations in DDR genes who have had benefit with platinum-based chemotherapy in first line setting The primary objective is to investigate the efficacy of this combination in terms of ORR
Patients will be eligible for the study based on alterations in a panel of specific DDR genes including BRCA1 BRCA2 PALB2 RAD51C RAD51D and other DDR genes as determined by a local assay according to local practice or by the central laboratory if local assay is not available
Our hypothesis is that those patients with alterations in DNA damage repair genes somatic and germline BRCA1 BRCA2 PALB2 RAD51C RAD51D and other functional DDR genes and who have benefit from platinum based therapy in first line might obtain an increased therapeutic effect with the combination of olaparib and durvalumab
This is an open-label single-arm multicentric phase II clinical trial of a combination of durvalumab and olaparib in patients with metastatic pancreatic cancer with alterations in DDR genes who have had benefit with platinum-based chemotherapy in first line setting The primary objective is to investigate the efficacy of this combination in terms of ORR
Patients will be eligible for the study based on alterations in a panel of specific DDR genes including BRCA1 BRCA2 PALB2 RAD51C RAD51D and other DDR genes as determined by a local assay according to local practice or by the central laboratory if local assay is not available
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004859-32 | EUDRACT_NUMBER | None | None |