NCT05870761

Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma

Phase II Trial of Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Casey Cosgrove · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests how well niraparib and dostarlimab work in treating patients with uterine serous carcinoma that has come back (after a period of improvement) (recurrent) and remains despite treatment (persistent). Niraparib belongs to a class of drugs called PARP inhibitors that prevent cancer cells from growing. Dostarlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Dostarlimab belongs to a class of drugs called PD-1 inhibitors that uses the patient's own immune system to treat cancer (immuno-therapy). Giving niraparib and dostarlimab may work better in treating patients with uterine serous carcinoma.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the efficacy, as measured by confirmed overall response rate (ORR) (partial and complete response, PR/CR) per Response Evaluation Criteria in Solid Tumors (RECIST version \[v\]1.1) based on investigator assessment of the combination niraparib and dostarlimab in patients with recurrent or persistent uterine serous carcinoma (USC). SECONDARY OBJECTIVES: I. Estimate the progression-free survival (PFS). II. Estimate clinical benefit rate (CBR), defined as the percentage of patients who have achieved complete response (CR), partial response (PR) or stable disease (SD). III. Evaluate the safety and tolerability of niraparib and dostarlimab combination. TRANSLATIONAL OBJECTIVE: I. Biomarker evaluation to predict response. OUTLINE: Patients receive dostarlimab intravenously (IV) and niraparib orally (PO) on study. Patients also undergo magnetic resonance imaging (MRI)/computed tomography (CT) and collection of blood samples throughout the trial. After completion of study treatment, patients are followed up every 6 months for 2 years and then annually thereafter.

Conditions

• Recurrent Endometrial Serous Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
PROCEDURE	Computed Tomography	Undergo MRI/CT
BIOLOGICAL	Dostarlimab	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI/CT
DRUG	Niraparib	Given PO

Timeline

• Start date: 2023-10-17
• Primary completion: 2025-09-19
• Completion: 2026-07-31
• First posted: 2023-05-23
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study