Trials / Recruiting
RecruitingNCT05700721
Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Niraparib | Given by PO |
| DRUG | Dostarlimab | Given by IV (vein) |
Timeline
- Start date
- 2023-06-02
- Primary completion
- 2029-12-31
- Completion
- 2029-12-31
- First posted
- 2023-01-26
- Last updated
- 2026-02-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05700721. Inclusion in this directory is not an endorsement.