Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365970
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-03-29
Brief Title:
Niraparib and Dostarlimab for Patients With MMR-DMSI-H Colorectal Cancers
Sponsor:
Ibrahim Halil Sahin
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase II Study of Niraparib and Dostarlimab for Patients With MMR-DMSI-H Colorectal Cancers A Proof of Concept Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 second line of therapy for patients with MSI-H CRC who experience disease progression on anti-PD1 based therapies is not well defined and there is an unmet need for research for patients with anti-PD1 refractory MSI-H CRC This study will examine the combination of niraparib and dostarlimab for a synergistic antitumor effect for patients with MSI-H CRC
Detailed Description:
In this single-arm phase II study the clinical effectiveness of niraparib in combination with dostarlimab will be investigated for patients with MSI-H colorectal cancer who had disease progression on anti-PD1-based therapy This study aims to leverage MRE11 deficiency and other HR pathway alterations by using Niraparib and also aims to create potential synergetic effect between dostarlimab with niraparib combination to induce clinically meaningful antitumor benefit Patients with advanced stage MSI-H CRC who progressed on first line anti-PD1 - anti-CTLA4 based therapy will be eligible for this study
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?:
False
Is an FDA AA801 Violation?:
None