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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06365970
Study type Interventional
Source University of Pittsburgh
Contact Debra Diecks, MSN
Phone 412-623-8364
Email diecksda@upmc.edu
Status Not yet recruiting
Phase Phase 2
Start date July 2024
Completion date July 2027