Clinical Trials /

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

NCT04068753

Description:

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.

Related Conditions:
  • Cervical Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Niraparib in Combination With TSR-042 in Patients With Recurrent or Progressive Cervix Cancer
  • Official Title: Phase II Trial of Niraparib in Combination With TSR-042 in Patients With Recurrent or Progressive Cervix Cancer

Clinical Trial IDs

  • ORG STUDY ID: OU-SCC-STAR
  • NCT ID: NCT04068753

Conditions

  • Recurrent Cervix Cancer
  • Progressive Cervix Cancer

Interventions

DrugSynonymsArms
NiraparibNiraparib + TSR-042
TSR-042Niraparib + TSR-042

Purpose

The purpose of this research study is to test the safety of Niraparib and TSR-042 as a combination treatment and see what effects (good and bad) this combination treatment has on patients with recurrent or progressive cervix cancer.

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 TSR-042 by vein
      every three weeks for 4 cycles then every six weeks.

      This study has two parts in order to evaluate the efficacy of combination treatment with
      Niraparib and TSR-042.

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Niraparib + TSR-042Experimental
  • Niraparib
  • TSR-042

Eligibility Criteria

        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 TSR-042 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of patients with response to treatment
Time Frame:1 year
Safety Issue:
Description:The proportion of patients treated with Niraparib and TSR-042 who achieve CR or PR, evaluated using RECIST v1.1

Secondary Outcome Measures

Measure:Number of patients who experience toxicity
Time Frame:2 years
Safety Issue:
Description:To determine the nature and degree of toxicity in combination of Niraparib and TSR-042
Measure:Duration of patients with response
Time Frame:up to 5 years
Safety Issue:
Description:To estimate the duration of response of patients treated with combination of Niraparib and TSR-042
Measure:Progression free survival
Time Frame:up to 5 years
Safety Issue:
Description:To estimate the progression free survival of patients treated with combination of Niraparib and TSR-042
Measure:Overall survival
Time Frame:up to 5 years
Safety Issue:
Description:To estimate the overall survival of patients treated with combination of Niraparib and TSR-042

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Oklahoma

Trial Keywords

  • Cervix Cancer
  • Niraparib
  • TSR-042

Last Updated