Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)
M.D. Anderson Cancer Center
Summary
To learn if the combination of niraparib and dostarlimab can help to control advanced cancer that has spread to the brain.
Description
Primary Objective: --To determine the intracranial objective response rate (ORR) of niraparib in combination with dostarlimab in patients with brain metastases. Secondary Objectives: * To determine the duration of intracranial response (DoR) of niraparib in combination with dostarlimab in patients with brain metastases. * To determine the intracranial ORR, defined as assessed by RANO-BM and iRANO. * To assess the systemic antitumor activity of niraparib in combination with dostarlimab in patients with brain metastases as defined by ORR, CBR (Stable Disease \[SD\]\>6m+CR+PR), progression fre…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 princ…
Interventions
- DrugNiraparib
Given by PO
- DrugDostarlimab
Given by IV (vein)
Location
- M D Anderson Cancer CenterHouston, Texas