Condition or disease | Intervention/treatment | Phase |
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Ovarian Neoplasms | Drug: Niraparib Drug: TSR-042 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | N/A |
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 Dostarlimab (TSR-042) in Patients With Platinum-Resistant Ovarian Cancer (MOONSTONE) |
Actual Study Start Date : | October 3, 2019 |
Estimated Primary Completion Date : | May 18, 2022 |
Estimated Study Completion Date : | October 30, 2024 |
Arm | Intervention/treatment |
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Experimental: Niraparib+TSR-042
Participants will receive both Niraparib and TSR-042 to evaluate the efficacy and safety of the combination of both drugs. Niraparib will be administered once daily (QD) continuously until Progressive disease (PD) or toxicity. Dostarlimab (TSR-042) will be administered via a 30-minute intravenous (IV) infusion on Day 1 every 3 weeks (Q3W) during Cycles 1 through 4. Beginning at Cycle 5, dostarlimab (TSR-042) will be administered via a 30-minute IV infusion on Day 1 of each 6-week cycle until PD or toxicity, for a maximum of 3 years.
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Drug: Niraparib
Niraparib is a potent, orally active poly (adenosine diphosphate-ribose) polymerase (PARP)-1 and PARP2 inhibitor being developed as a treatment for participants with tumors that harbor defects in the homologous recombination deoxyribonucleic acid (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 programmed cell death-1 (PD-1) resulting in inhibition of binding to programmed cell-death receptor ligands 1 and 2 (PD-L1 and PD-L2).
Other Name: Dostarlimab
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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:
Exclusion Criteria:
Participant with a known history of human immunodeficiency virus (HIV) are allowed if they meet all of the following criteria:
United States, Arizona | |
GSK Investigational Site | |
Scottsdale, Arizona, United States, 85258 | |
GSK Investigational Site | |
Tucson, Arizona, United States, 85711 | |
United States, California | |
GSK Investigational Site | |
Duarte, California, United States, 91010 | |
GSK Investigational Site | |
Long Beach, California, United States, 90806 | |
GSK Investigational Site | |
Newport Beach, California, United States, 92663 | |
GSK Investigational Site | |
Orange, California, United States, 92868 | |
GSK Investigational Site | |
San Francisco, California, United States, 94158 | |
GSK Investigational Site | |
Solvang, California, United States, 93463 | |
United States, Florida | |
GSK Investigational Site | |
Coral Gables, Florida, United States, 33146 | |
GSK Investigational Site | |
Deerfield Beach, Florida, United States, 33442 | |
GSK Investigational Site | |
Miami, Florida, United States, 33136 | |
GSK Investigational Site | |
Orlando, Florida, United States, 32804 | |
GSK Investigational Site | |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
GSK Investigational Site | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
GSK Investigational Site | |
Indianapolis, Indiana, United States, 46250 | |
United States, Iowa | |
GSK Investigational Site | |
Iowa City, Iowa, United States, 52242-1009 | |
United States, Louisiana | |
GSK Investigational Site | |
Covington, Louisiana, United States, 70433 | |
United States, Maryland | |
GSK Investigational Site | |
Baltimore, Maryland, United States, 21287 | |
GSK Investigational Site | |
Silver Spring, Maryland, United States, 20902 | |
GSK Investigational Site | |
Silver Spring, Maryland, United States, 20910 | |
United States, Massachusetts | |
GSK Investigational Site | |
Boston, Massachusetts, United States, 02215 | |
GSK Investigational Site | |
Burlington, Massachusetts, United States, 01805 | |
United States, Minnesota | |
GSK Investigational Site | |
Maplewood, Minnesota, United States, 55109 | |
GSK Investigational Site | |
Minneapolis, Minnesota, United States, 55404 | |
United States, Mississippi | |
GSK Investigational Site | |
Jackson, Mississippi, United States, 39216 | |
United States, New Mexico | |
GSK Investigational Site | |
Albuquerque, New Mexico, United States, 87131 | |
United States, New York | |
GSK Investigational Site | |
Harrison, New York, United States, 10604 | |
GSK Investigational Site | |
New York, New York, United States, 10022 | |
GSK Investigational Site | |
New York, New York, United States, 10065 | |
United States, North Carolina | |
GSK Investigational Site | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
GSK Investigational Site | |
Cleveland, Ohio, United States, 44106 | |
GSK Investigational Site | |
Cleveland, Ohio, United States, 44111 | |
GSK Investigational Site | |
Cleveland, Ohio, United States, 44124 | |
GSK Investigational Site | |
Columbus, Ohio, United States, 43210 | |
United States, Oregon | |
GSK Investigational Site | |
Eugene, Oregon, United States, 97401 | |
GSK Investigational Site | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
GSK Investigational Site | |
Willow Grove, Pennsylvania, United States, 19090 | |
United States, Rhode Island | |
GSK Investigational Site | |
Providence, Rhode Island, United States, 02905 | |
United States, Tennessee | |
GSK Investigational Site | |
Chattanooga, Tennessee, United States, 37403 | |
GSK Investigational Site | |
Germantown, Tennessee, United States, 38138 | |
United States, Texas | |
GSK Investigational Site | |
Austin, Texas, United States, 78731 | |
GSK Investigational Site | |
Fort Worth, Texas, United States, 76104 | |
GSK Investigational Site | |
San Antonio, Texas, United States, 78229 | |
GSK Investigational Site | |
The Woodlands, Texas, United States, 77380 | |
United States, Virginia | |
GSK Investigational Site | |
Charlottesville, Virginia, United States, 22903 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Tracking Information | |||||
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First Submitted Date ICMJE | May 16, 2019 | ||||
First Posted Date ICMJE | May 20, 2019 | ||||
Last Update Posted Date | June 4, 2021 | ||||
Actual Study Start Date ICMJE | October 3, 2019 | ||||
Estimated Primary Completion Date | May 18, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Objective Response Rate (ORR) [ Time Frame: Up to 5 years ] ORR is defined as the proportion of participants who have achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 based on Investigator assessment.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer | ||||
Official Title ICMJE | A Phase 2 Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Patients With Platinum-Resistant Ovarian Cancer (MOONSTONE) | ||||
Brief Summary | This is an open-label, single-arm Phase 2 study to evaluate the efficacy and safety of combination of niraparib and dostarlimab (TSR-042) in participants with advanced, relapsed, high-grade ovarian, fallopian tube, endometrioid, clear cell ovarian or primary peritoneal cancer without known breast cancer susceptibility gene (BRCA) mutation who have platinum-resistant disease and who have also been previously treated with bevacizumab. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Ovarian Neoplasms | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Niraparib+TSR-042
Participants will receive both Niraparib and TSR-042 to evaluate the efficacy and safety of the combination of both drugs. Niraparib will be administered once daily (QD) continuously until Progressive disease (PD) or toxicity. Dostarlimab (TSR-042) will be administered via a 30-minute intravenous (IV) infusion on Day 1 every 3 weeks (Q3W) during Cycles 1 through 4. Beginning at Cycle 5, dostarlimab (TSR-042) will be administered via a 30-minute IV infusion on Day 1 of each 6-week cycle until PD or toxicity, for a maximum of 3 years.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
41 | ||||
Original Estimated Enrollment ICMJE |
150 | ||||
Estimated Study Completion Date ICMJE | October 30, 2024 | ||||
Estimated Primary Completion Date | May 18, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03955471 | ||||
Other Study ID Numbers ICMJE | 213353 3000-02-006 ( Other Identifier: Tesaro ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Tesaro, Inc. | ||||
Study Sponsor ICMJE | Tesaro, Inc. | ||||
Collaborators ICMJE | Gynecologic Oncology Group | ||||
Investigators ICMJE |
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PRS Account | Tesaro, Inc. | ||||
Verification Date | June 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |