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

NCT05870761 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: OSU-22103NCI-2023-03667
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Endometrial Serous Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Defined as the percentage of patients with complete response (CR), or partial response (PR), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 criteria using investigator's review. Will be estimated and reported with 95% confidence intervals (exact).

  Up to 2 years

Secondary Outcomes (5)

• Clinical benefit rate

  Up to 2 years

• Progression free survival (PFS)

  From the date of study entry until disease progression or death (whichever occurs first), assessed up to 2 years

• Overall survival (OS)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

• Incidence of adverse events (AEs)

  Up to 90 days

Study Arms (1)

Treatment (dostarlimab, niraparib)

EXPERIMENTAL

Patients receive dostarlimab IV and niraparib PO on study. Patients also undergo MRI/CT and collection of blood samples throughout the trial.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Dostarlimab; Procedure: Magnetic Resonance Imaging; Drug: Niraparib

Interventions

Magnetic Resonance Imaging PROCEDURE

Undergo MRI/CT

Also known as: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Treatment (dostarlimab, niraparib)

Niraparib DRUG

Given PO

Also known as: MK-4827, MK4827

Treatment (dostarlimab, niraparib)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (dostarlimab, niraparib)

Computed Tomography PROCEDURE

Undergo MRI/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Treatment (dostarlimab, niraparib)

Dostarlimab BIOLOGICAL

Given IV

Also known as: ANB011, Dostarlimab-gxly, Immunoglobulin G4, Anti-programmed Cell Death Protein 1 (PDCD1) (Humanized Clone ABT1 Gamma4-chain), Disulfide with Humanized Clone ABT1 Kappa-chain, Dimer, Jemperli, TSR 042, TSR-042, TSR042

Treatment (dostarlimab, niraparib)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have recurrent or persistent uterine serous carcinoma based on previous biopsy or surgery, and have previously received at least carboplatin/paclitaxel. Mixed and carcinosarcoma histology cases will be eligible if there is a serous component in the tumor
• 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
• Hemoglobin \>= 9 g/dL
• Serum creatinine =\< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance \>= 60 mL/min using the Cockcroft-Gault equation
• Total bilirubin =\< 1.5 x ULN (=\< 2.0 in patients with known Gilberts syndrome) OR direct bilirubin =\< 1 x ULN
• Aspartate aminotransferase and alanine aminotransferase =\< 2.5 x ULN unless liver metastases are present, in which case they must be =\< 5 x ULN

You may not qualify if:

• 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
• Participant has had any known grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \> 4 weeks and was related to the most recent treatment
• Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
• Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled hypertension, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. Participants with hypertension but be well controlled before first dose of niraparib
• Participant must not have had diagnosis, detection, or treatment of another type of cancer =\< 2 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer that has been definitively treated)
• Participant must not have a known history of brain or leptomeningeal metastases

Sponsors & Collaborators

• Casey Cosgrove: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Specimen Handling; dostarlimab; Immunoglobulin G; Disulfides; Magnetic Resonance Spectroscopy; niraparib

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Casey Cosgrove, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: October 17, 2023
• Primary Completion: September 19, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)