Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

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: NCT03955471
Recruitment Status : Not yet recruiting
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
Tesaro, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Platinum-resistant Ovarian Cancer Drug: Niraparib Drug: TSR-042 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : June 30, 2019
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : July 30, 2023


Arm Intervention/treatment
Experimental: ARM 1
Patients will receive both Niraparib and TSR-042 to evaluate the efficacy and safety of the combination of both drugs.
Drug: Niraparib
Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.
Other Name: ZEJULA

Drug: TSR-042
TSR-042 is a humanized monoclonal antibody that binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).
Other Name: Dostarlimab




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]
    Proportion of patients who have achieved confirmed CR or PR, evaluated using RECIST v1.1 based on Investigator assessment.


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
    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.

  2. Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]
    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.

  3. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    OS is defined as the time from the date of the first dose of study treatment to the date of death by any cause.

  4. Disease Control Rate (DCR) [ Time Frame: Up to 5 years ]
    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.

  5. Objective Response Rate Based on Independent Review Committee Assessment [ Time Frame: Up to 5 years ]
    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.



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.


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

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): NCT03955471


Contacts
Layout table for location contacts
Contact: Beth Zaharoff 781-209-5485 bzaharoff@tesarobio.com

Sponsors and Collaborators
Tesaro, Inc.
Gynecologic Oncology Group

Layout table for additonal information
Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT03955471     History of Changes
Other Study ID Numbers: 3000-02-006
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tesaro, Inc.:
Open-label
Single-arm
Efficacy and Safety
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents