Brain Metastases Clinical Trial
Official title:
Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)
To learn if the combination of niraparib and dostarlimab can help to control advanced cancer that has spread to the brain.
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 free survival (PFS) and overall survival (OS). - Evaluate the safety and tolerability of niraparib in combination with dostarlimab in patients with brain metastases. Explorative Objectives: - To assess predictive and pharmacodynamic (PD) markers of response. - To assess the immune-related effects of niraparib and dostarlimab. - To evaluate the effects of niraparib and dostarlimab on steroid, cranial radiation, and opiate pain medication use and seizure reduction. - To assess ctDNA in cerebrospinal fluid (CSF) in all participants, and explore relationship to matched blood and tissue samples, when available. - To explore biomarkers of response and resistance in CSF. - To evaluate niraparib and dostarlimab concentrations or pharmacokinetics (PK) - To screen for the presence of dostarlimab anti-drug antibodies (ADA) ;
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