Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)
Trial Parameters
Brief Summary
To learn if the combination of niraparib and dostarlimab can help to control advanced cancer that has spread to the brain.
Eligibility Criteria
Inclusion Criteria: 1\. Age ≥ 18 years old. 2. Participant must have brain metastasis and either 1\. Advanced BRCA1/2m cancer 2. Advanced HRR-aberrant, non-BRCA1/2m cancer 3. Advanced small cell lung cancer 4. Advanced non-small cell lung cancer 5. Advanced Triple Negative Breast Cancer 3. In cohorts 1 and 2, subjects will be eligible for this study based on the presence of actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes at the discretion of the principal investigator in consultation with the MD Anderson Cancer Center Institute for Personalized Cancer Therapy Precision Oncology Decision Support (PODS) group. Variant interpretation for actionability will be performed by PODS. 4\. Any prior SRS to brain lesions or prior excision must have occurred ≥1 week before the start of dosing for this study. Lesions situated in a previously irradiated area a