Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441747
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
Phase II Study of the Combination of Durvalumab MEDI4736 PDL1 Inhibitor and Olaparib PARP Inhibitor in Advanced Cholangiocarcinoma After Initial Chemotherapy and Durvalumab BIL-PPP
Sponsor:
Australasian Gastro-Intestinal Trials Group
Organization:
Australasian Gastro-Intestinal Trials Group
Study Overview
Official Title:
Phase II Study of the Combination of Durvalumab MEDI4736 PDL1 Inhibitor and Olaparib PARP Inhibitor in Advanced Cholangiocarcinoma After Initial Chemotherapy and Durvalumab BIL-PPP
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 aim of this study is to investigate whether the combination of durvalumab and olaparib in the maintenance setting after initial chemotherapy and durvalumab will benefit patients with locally advanced or metastatic cholangiocarcinoma
Detailed Description:
The primary objectives are
i To describe the efficacy of PARPi and PDL1 inhibition in the maintenance setting of metastatic cholangiocarcinomas
ii To refine selection of the patient population who are most likely to benefit from the combination of PDL1 Durvalumab and PARP Olaparib inhibition in the maintenance setting following initial chemotherapy cisplatin gemcitabine Durvalumab post hoc translational analysis
The secondary objectives are i To evaluate toxicity of the combination of durvalumab and olaparib ii To evaluate progression-free and overall survival with the combination of durvalumab and olaparib PFS OS
i To describe the efficacy of PARPi and PDL1 inhibition in the maintenance setting of metastatic cholangiocarcinomas
ii To refine selection of the patient population who are most likely to benefit from the combination of PDL1 Durvalumab and PARP Olaparib inhibition in the maintenance setting following initial chemotherapy cisplatin gemcitabine Durvalumab post hoc translational analysis
The secondary objectives are i To evaluate toxicity of the combination of durvalumab and olaparib ii To evaluate progression-free and overall survival with the combination of durvalumab and olaparib PFS OS
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