Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer

NCT04068753 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: OU-SCC-STAROU-SCC-TESARO-002
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this research study is to test the safety of Niraparib and dostarlimab as a combination treatment and see what effects (good and bad) this combination treatment has on patients with recurrent or progressive cervix cancer.

Conditions

Recurrent Cervix Cancer; Progressive Cervix Cancer

Keywords

Cervix Cancer; Niraparib; dostarlimab

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with response to treatment

  The proportion of patients treated with Niraparib and dostarlimab who achieve CR or PR, evaluated using RECIST v1.1

  1 year

Secondary Outcomes (4)

• Number of patients who experience toxicity

  2 years

• Duration of patients with response

  up to 5 years

• Progression free survival

  up to 5 years

• Overall survival

  up to 5 years

Study Arms (1)

Niraparib + dostarlimab

EXPERIMENTAL

Drug: Niraparib; Drug: dostarlimab

Interventions

Niraparib DRUG

Niraparib: 200 mg, oral, once daily, days 1-21

Niraparib + dostarlimab

dostarlimab DRUG

dostarlimab: 500 mg IV, every three weeks for 4 cycles followed by 1000 mg every six weeks for up to two years

Niraparib + dostarlimab

Eligibility Criteria

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

You may qualify if:

• Patient is female at least 18 years of age.
• Patient has histologically proven cervical cancer, which is recurrent or progressive
• Patient has archival tumor tissue available or a fresh biopsy of recurrent or persistent tumor must be obtained prior to study treatment initiation. Availability of tissue does not affect eligibility of patient on trial, but PD-L1 status and next-generation sequencing data is required to be collected for the trial.
• Patient has measurable lesions by RECIST v1.1.
• Patient has an ECOG performance status of 0 to 1.
• Patients must have received at least one or more prior systemic treatment regimens. Chemotherapy with radiation is not considered systemic treatment. Prior treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 therapies is allowed; however, these treatments could not have been discontinued due to immune related adverse events and patient cannot have progressed while on anti-PD-1, anti-PD-L1 or anti PD-L2 given in combination with chemotherapy or while on maintenance immunotherapy.
• Patient has adequate organ function, defined per protocol.
• Patient is able to take oral medications.
• Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
• If of childbearing potential, has a negative pregnancy test within 7 days prior to taking study medication or agrees to abstain from activities that could result in pregnancy from enrollment through 180 days after the last dose of study treatment, or be of non- childbearing potential.

You may not qualify if:

• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases may participate provided they are stable for at least 4 weeks prior to the first dose of study treatment and have not been using steroids for at least 7 days prior to study treatment.
• Known additional malignancy that required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin.
• Patient is considered a poor medical risk that would interfere with cooperation with the requirements of the study.
• Received a transfusion (platelets or red blood cells) ≤4 weeks prior to initiating protocol therapy.
• Received colony stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
• 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.
• Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
• Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, 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
• Pregnant or breastfeeding or expecting to conceive children within the projected duration of the study and for 180 days after the last dose of study treatment.
• Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy, and ≤ 10mg a day prednisone or equivalent.
• Known history of human immunodeficiency virus (HIV) (HIV ½ antibodies).
• Known active hepatitis B or hepatitis C.
• Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Not recovered to ≤Grade 1 or to baseline from chemotherapy induced AEs. Note: Patient with ≤ Grade 1 neuropathy or ≤ Grade 2 alopecia is an exception to this criterion and may qualify for the study.
• Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.

Sponsors & Collaborators

• University of Oklahoma: lead
• Tesaro, Inc.: collaborator

Study Sites (4)

Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Louisiana State University Health Science Center

New Orleans, Louisiana, 70112, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

niraparib; dostarlimab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Debra Richardson, MD

  Stephenson 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

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: February 26, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)