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A Phase 2 Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and TSR-042 in Patients With Platinum Resistant Ovarian Cancer

NCT03955471

Description:

This is an open-label, single-arm Phase 2 study to evaluate the efficacy and safety of combination of niraparib and TSR-042 in patients with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer without known BRCA mutation who have platinum-resistant disease and who have also been previously treated with bevacizumab.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase 2 Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and TSR-042 in Patients With Platinum Resistant Ovarian Cancer
  • Official Title: A Phase 2 Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and TSR-042 in Patients With Platinum-Resistant Ovarian Cancer (MOONSTONE)

Clinical Trial IDs

  • ORG STUDY ID: 3000-02-006
  • NCT ID: NCT03955471

Conditions

  • Platinum-resistant Ovarian Cancer

Interventions

DrugSynonymsArms
NiraparibZEJULAARM 1
TSR-042DostarlimabARM 1

Purpose

This is an open-label, single-arm Phase 2 study to evaluate the efficacy and safety of combination of niraparib and TSR-042 in patients with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer without known BRCA mutation who have platinum-resistant disease and who have also been previously treated with bevacizumab.

Trial Arms

NameTypeDescriptionInterventions
ARM 1ExperimentalPatients will receive both Niraparib and TSR-042 to evaluate the efficacy and safety of the combination of both drugs.
  • Niraparib
  • TSR-042

Eligibility Criteria

        Inclusion Criteria:

          -  Patient must be female ≥ 18 years of age, able to understand the study procedures, and
             subsequently agreed to participate in the study by providing written informed consent.

          -  Patients must have recurrent high-grade serous, endometrioid, or clear cell ovarian,
             fallopian tube, or primary peritoneal cancer.

          -  Patients must be considered resistant to the last administered platinum therapy.

          -  Patients must have completed at least 1 but no more than 3 prior lines of therapy for
             advanced or metastatic ovarian cancer.

          -  Patients must have been previously treated with platinum-based regimen, taxane
             agent(s), and bevacizumab.

          -  Patient has measurable disease according to RECIST v.1.1.

          -  Patient has an ECOG performance status of 0 or 1.

          -  Patient has adequate organ function.

          -  Females with childbearing potential have a serum pregnancy test that is negative 72
             prior first dose and are not breastfeeding. Patient must also agree to abstain from
             activities that could result in pregnancy from enrollment through 180 days after the
             last dose of study treatment.

          -  Patient is willing to undergo a pre-treatment tumor biopsy if an appropriate archival
             tumor tissue sample is not available.

          -  Patient must agree to complete HRQoL questionnaires throughout the study.

        Exclusion Criteria:

          -  Patient who experienced disease progression within 3 months of first-line platinum
             therapy.

          -  Patients with a known BRCA 1 or 2 mutation.

          -  Patient has received prior therapy with an anti-PD-1 or anti-PD-2 agent.

          -  Patient has a known hypersensitivity to TSR-042, Niraparib, their components, or their
             excipients.

          -  Patient has a known history of myelodysplastic syndrome or acute myeloid leukemia.

          -  Patient has not recovered from prior chemotherapy induced AE's.

          -  Patient has a known diagnosis of immunodeficiency or is receiving systemic steroid
             therapy exceeding an equivalent of prednisone 10 mg daily or any other form of
             immunosuppressive therapy within 7 days prior to the first dose of study treatment.

          -  Patient is participating in a treatment study or has participated in a study of an
             investigational agent within 4 weeks of the first dose of treatment.

          -  Patient has received prior systemic anticancer therapy including cytotoxic
             chemotherapy, hormonal therapy given with the intention to treat ovarian cancer, or
             biological therapy within 3 weeks of the first dose of study treatment.

          -  Patient has received live vaccine within 30 days of planned start of study therapy

          -  Patient has symptomatic uncontrolled brain or leptomeningeal metastases. (If
             investigator feels patient symptoms are not symptomatic patients can undergo a scan to
             confirm for eligibility).

          -  Patient had major surgery with 4 weeks of starting the study.

          -  Patient has a known additional malignancy that progressed or required active treatment
             within the last 2 years.

          -  Patient is considered a poor medical risk due to a serious, uncontrolled medical
             disorder, nonmalignant systemic disease or active controlled infection.

          -  Patient has a history or current evidence of any condition, therapy, or laboratory
             abnormality that might confound the results of the study.

          -  Patient has known active hepatitis B (hepatitis B surface antigen reactive) or
             hepatitis C (hepatitis C virus ribonucleic acid, qualitative).

          -  Patient has a known history of human immunodeficiency virus.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to 5 years
Safety Issue:
Description:Proportion of patients who have achieved confirmed CR or PR, evaluated using RECIST v1.1 based on Investigator assessment.

Secondary Outcome Measures

Measure:Duration of Response (DOR)
Time Frame:Up to 5 years
Safety Issue:
Description:DOR is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST v.1.1 based on Investigator assessment or death by any cause in the absence of progression by RECIST v.1.1.
Measure:Progression-free Survival (PFS)
Time Frame:Up to 5 years
Safety Issue:
Description:PFS is defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by RECIST v.1.1 based on Investigator assessment or death by any cause in the absence of progression by RECIST v.1.1.
Measure:Overall Survival (OS)
Time Frame:Up to 5 years
Safety Issue:
Description:OS is defined as the time from the date of the first dose of study treatment to the date of death by any cause.
Measure:Disease Control Rate (DCR)
Time Frame:Up to 5 years
Safety Issue:
Description:DCR is defined as the percentage of patients who have achieved best overall response (BOR) of CR, PR, or SD per RECIST v.1.1 based on the Investigator's assessment.
Measure:Objective Response Rate Based on Independent Review Committee Assessment
Time Frame:Up to 5 years
Safety Issue:
Description:ORR based on independent review committee assessment is defined as the percentage of patients who have achieved confirmed CR or PR per RECIST v1.1 based on the independent review committee assessment.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Tesaro, Inc.

Trial Keywords

  • Open-label
  • Single-arm
  • Efficacy and Safety

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