Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers (NCT06365970) | Clinical Trial Compass
WithdrawnPhase 2
Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers
Stopped: Per drug sponsor request.
0Started 2025-01-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Histologically confirmed mismatch repair deficient or microsatellite instability high advanced stage colorectal cancer
ā. Measurable disease per RECIST v1.1
ā. ECOG 0 to 2
ā. Age ā„ 18 years
ā. Able to swallow oral medication (tablets).
ā. Progression on prior anti-PD1 Ā± anti-CTLA4 therapy.
ā. Adequate organ function based on the following lab assessments:
ā. ANC must be ā„ 1500/mm3.
Exclusion criteria
ā. More than 2 lines of systemic therapy (excluding adjuvant therapy)
ā. Prior oxaliplatin based chemotherapy for metastatic disease. This excludes adjuvant oxaliplatin. Patients who received oxaliplatin based chemotherapy for metastatic disease before determination of MMR-D/MSI-H status (due to test turn-around time) can be enrolled if they received 4 or less cycle of oxaliplatin treatment (each cycle is one dose).
ā. More than 1 line of anti-PD1 based therapy.
ā. History of severe hypersensitivity to anti-PD1 monoclonal antibodies
ā. Active autoimmune disease requiring immune suppression except following conditions:
ā. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone without an active complication are eligible for the study.