Spots Global Cancer Trial Database for Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)
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Trial Identification
Brief 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)
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)
Study ID: NCT05700721
Conditions
Study Description
Brief Summary: To learn if the combination of niraparib and dostarlimab can help to control advanced cancer that has spread to the brain.
Detailed 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 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)
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
M D Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Timothy Yap, MBBS,PHD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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