Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT05870761
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2023-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma
Sponsor:
Casey Cosgrove
Organization:
Study Overview
Official Title:
Phase II Trial of Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-03667 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |