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Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04068753
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : November 22, 2022
Tesaro, Inc.
Information provided by (Responsible Party):
University of Oklahoma

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.

Condition or disease Intervention/treatment Phase
Recurrent Cervix Cancer Progressive Cervix Cancer Drug: Niraparib Drug: dostarlimab Phase 2

Detailed Description:

Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will receive treatment with Niraparib daily and dostarlimab by vein every three weeks for 4 cycles then every six weeks.

Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable, bad side effects.

Patients will be monitored during treatment with tests and exams and after treatment completion for up to 5 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Niraparib + dostarlimab Drug: Niraparib
Niraparib: 200 mg, oral, once daily, days 1-21

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

Primary Outcome Measures :
  1. Proportion of patients with response to treatment [ Time Frame: 1 year ]
    The proportion of patients treated with Niraparib and dostarlimab who achieve CR or PR, evaluated using RECIST v1.1

Secondary Outcome Measures :
  1. Number of patients who experience toxicity [ Time Frame: 2 years ]
    To determine the nature and degree of toxicity in combination of Niraparib and dostarlimab

  2. Duration of patients with response [ Time Frame: up to 5 years ]
    To estimate the duration of response of patients treated with combination of Niraparib and dostarlimab

  3. Progression free survival [ Time Frame: up to 5 years ]
    To estimate the progression free survival of patients treated with combination of Niraparib and dostarlimab

  4. Overall survival [ Time Frame: up to 5 years ]
    To estimate the overall survival of patients treated with combination of Niraparib and dostarlimab

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is female at least 18 years of age.
  2. Patient has histologically proven recurrent or progressive cervix cancer
  3. Patient has archival tumor tissue available or a fresh biopsy of recurrent or persistent tumor must be obtained prior to study treatment initiation.
  4. Patient has measurable lesions by RECIST v1.1.
  5. Patient has an ECOG performance status of 0 to 1.
  6. Patients must have received at least one or more prior systemic treatment regimen. Chemotherapy with radiation is not considered systemic treatment.
  7. Patient has adequate organ function, defined per protocol
  8. Patient is able to take oral medications.
  9. Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
  10. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  11. 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.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Patient is considered a poor medical risk that would interfere with cooperation with the requirements of the study.
  4. Received a transfusion (platelets or red blood cells) ≤4 weeks prior to initiating protocol therapy.
  5. Received colony stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
  6. 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.
  7. Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
  8. Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection.
  9. 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.
  10. 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.
  11. Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
  12. Known active hepatitis B or hepatitis C.
  13. 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.
  14. 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.
  15. 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.
  16. Prior cytotoxic chemotherapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors), hormonal agents within 5 half-lives, or monoclonal antibodies (mAb) within 5 half-lives or 4 weeks (whichever is shorter) of that treatment prior to study Day 1 or radiation therapy encompassing > 20% of the bone marrow within 2 weeks or any radiation therapy within 4 weeks prior to study Day 1.
  17. Major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
  18. Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  19. Received a live vaccine within 14 days of planned start of study therapy.
  20. Prior treatment with a known PARP inhibitor.
  21. Known hypersensitivity to niraparib or Dostarlimab components or excipients.
  22. Patient experienced ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
  23. History of interstitial lung disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068753

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Contact: Lead Gyn Onc, Nurse 1-405 271-8777 SCC-IIT-Office@ouhsc.edu
Contact: Ingrid Block, APRN 1-405-271-8777 ingrid-block@ouhsc.edu

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United States, New York
Montefiore Medical Center Terminated
Bronx, New York, United States, 10461
United States, North Carolina
University of North Carolina Terminated
Chapel Hill, North Carolina, United States, 27514
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Lead Gyn Onc Nurse    405-271-8777    SCC-IIT-Office@ouhsc.edu   
Principal Investigator: Debra L Richardson, MD         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Sheena Clift, PhD       shc2wn@hscmail.mcc.virginia.edu   
Principal Investigator: Linda Duska, MD         
Sponsors and Collaborators
University of Oklahoma
Tesaro, Inc.
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Principal Investigator: Debra Richardson, MD Stephenson Cancer Center
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT04068753    
Other Study ID Numbers: OU-SCC-STAR
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oklahoma:
Cervix Cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Disease Attributes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents