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Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma | Clinical Trials | Clareo Health

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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

NCT05870761•Casey Cosgrove

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1
•Participant must be \>= 18 years of age
•Patient has archival tumor tissue available or a fresh biopsy of recurrent or persistent tumor must be obtained prior to study treatment initiation
•Patient must have measurable disease by RECIST
•No more than three prior chemotherapy regimens (does not include chemoradiation) are permitted. One of the previous lines of treatment must include carboplatin and paclitaxel
•Prior PD1/PDL1 inhibitors (including single-agent pembrolizumab, other immunotherapy agents, or combination pembrolizumab and lenvatinib) therapy will be allowed if the patient did not have immune associated toxicity leading to discontinuation.
•* Patients who have progressed on prior PD1/PDL1 inhibitors may be allowed to participate if the study PI and treating physician deem it to be within the patient's best interest.
•Prior chemoradiation therapy for adjuvant treatment or pelvic recurrence is permitted. Chemotherapy in this setting, is not counted as prior line of chemotherapy
•Absolute neutrophil count \>= 1,500/uL
•Platelets \>= 100,000/uL
+16 more criteria

Exclusion Criteria

•Participant must not be simultaneously enrolled in any interventional clinical trial
•Participant must not have had major surgery =\< 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects
•Participant must not have received investigational therapy =\< 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior initiating protocol therapy
•Participant's last treatment with platinum based chemotherapy was =\< 4 weeks from initiation of protocol therapy
•Participant has had radiation therapy encompassing \> 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to day 1 of protocol therapy
•Participant must not have a known hypersensitivity to niraparib and dostarlimab components or excipients
•Participant must not have previously progressed on PARP inhibitor
•Participant experienced \>= grade 3 immune-related adverse event (AE) with prior immunotherapy, with the exception of non-clinically significant lab abnormalities
•Participant must not have received a transfusion (platelets or red blood cells) =\< 4 weeks prior to initiating protocol therapy
•Participant must not have received colony-stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy
+13 more criteria

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Key Dates

Start Date

October 17, 2023

Primary Completion Date

September 19, 2025

Completion Date

December 31, 2025

Last Updated

November 20, 2025

Enrollment

ACTUAL participants

Conditions

Recurrent Endometrial Serous Adenocarcinoma

Interventions

Biospecimen Collection

PROCEDURE

Computed Tomography

PROCEDURE

Dostarlimab

BIOLOGICAL

Magnetic Resonance Imaging

PROCEDURE

Niraparib

DRUG