Ovarian Cancer Clinical Trial
A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer
Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance of disease response. Given the unmet medical need of participants with advanced or metastatic ovarian cancer, this study design will enable investigators to provide participants with current SOC for ovarian cancer for the duration of the study. This is a global, multicenter, randomized, double-blind, controlled Phase 3 study that will primarily compare progressive survival rate of PD-L1 positive patients and also to compare progression-free survival (PFS) of all participants with Stage III or IV high-grade nonmucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab, and niraparib to SOC platinum-based combination therapy. The currently recommended SOC therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab. Participants will receive SOC during the chemotherapy Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent bevacizumab use must be determined prior to randomization at cycle 2. Approximately 1228 participants will be enrolled into the study and the duration of the study will be approximately 78 months.
Participants must be female, >=18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent.
Participants with a histologically confirmed diagnosis of high-grade nonmucinous epithelial ovarian (serous, endometrioid, clear cell, carcinosarcoma, and mixed pathologies), fallopian tube, or peritoneal cancer that is Stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria.
All participants with Stage IV disease are eligible. This includes those with inoperable disease, those who undergo primary debulking surgery (PDS) (R0 or macroscopic disease), or those for whom neoadjuvant chemotherapy (NACT) is planned.
Participants with Stage III are eligible if they meet protocol defined criteria.
Participants must provide a blood sample for circulating tumor deoxyribonucleic acid (ctDNA) homologous recombinant repair (HRR) testing at pre-screening or screening.
Participant must provide a minimum of 1 formalin-fixed paraffin embedded (FFPE) block slide at pre-screening or screening for PD-L1, homologous recombinant deficiency (HRD) testing.
Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin) within 3 days prior to receiving the first dose of study treatment.
Participants must be postmenopausal, free from menses for >1 year, surgically sterilized, or willing to use highly effective contraception to prevent pregnancy or must agree to abstain from activities that could result in pregnancy throughout the study, starting with enrollment through 180 days after the last dose of study treatment.
Participants must have adequate organ function: Absolute neutrophil count (ANC) >=1500/micro liter (μL;) Platelet count >=100000/μL; Hemoglobin >=9 grams per deciliter (g/dL); Serum creatinine <=1.5 × upper limit of normal (ULN) or calculated creatinine clearance >=60 milliliters per minute (mL/min) using the Cockcroft-Gault equation; total bilirubin <=1.5 × ULN or direct bilirubin <=1.5 × ULN; AST and ALT <=2.5 × ULN unless liver metastases are present, in which case they must be <=5 × ULN.
Participants must have an ECOG score of 0 or 1.
Participants must have normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP <=140 millimeters of mercury (mmHg) and/or diastolic BP <=90 mmHg).
Participants must agree to complete health related quality of life (HRQoL) questionnaires throughout the study.
Participants must be able to take oral medication.
Participant has mucinous, germ cell, transitional cell, or undifferentiated tumor.
Participant has low-grade or Grade 1 epithelial ovarian cancer.
Participant has not adequately recovered from prior major surgery.
Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use, during niraparib treatment and for 30 days after receiving the final dose of study treatment).
Participant has known active central nervous system metastases, carcinomatous meningitis, or both.
Participant has clinically significant cardiovascular disease.
Participant has a bowel obstruction by clinical symptoms or computed tomography (CT) scan, subocclusive mesenteric disease, abdominal or gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess.
Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
Participant has been diagnosed and/or treated with any therapy for invasive cancer <5 years from study enrollment, completed adjuvant chemotherapy and/or targeted therapy (example, trastuzumab) less than 3 years from enrollment, or completed adjuvant hormonal therapy less than 4 weeks from enrollment.
Participants with definitively treated non-invasive malignancies such as cervical carcinoma in situ, ductal carcinoma in situ, Grade 1 or 2, Stage I endometrial cancer, or non-melanomatous skin cancer are allowed.
Participant is at increased bleeding risk due to concurrent conditions (example, major injuries or major surgery within the past 28 days prior to start of study treatment and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
Participant is immunocompromised.
Participant has known active hepatitis B (example, hepatitis B surface antigen reactive) or hepatitis C (example, hepatitis C virus ribonucleic acid [qualitative] is detected).
Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or uncontrolled infection.
Participant has had investigational therapy administered within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
Participant has received a live vaccine within 14 days of planned start of study therapy. Seasonal influenza vaccines that do not contain live viruses are allowed.
Participant has a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, niraparib, bevacizumab, dostarlimab, or their excipients.
Prior treatment for high-grade nonmucinous epithelial ovarian, fallopian tube, or peritoneal cancer (immunotherapy, anti-cancer therapy, radiation therapy).
Participant has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic therapy (example, thyroid hormone or insulin).
Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment.
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There are 187 Locations for this study
Anchorage Alaska, 99508, United States
Phoenix Arizona, 85016, United States
Tucson Arizona, 85704, United States
Tucson Arizona, 85710, United States
Tucson Arizona, 85711, United States
Los Angeles California, 90027, United States
Los Angeles California, 90048, United States
Newport Beach California, 92663, United States
Orange California, 92868, United States
Farmington Connecticut, 06030, United States
Hartford Connecticut, 06102, United States
Gainesville Florida, 32608, United States
Jacksonville Florida, 32256, United States
Warrenville Illinois, 60555, United States
Zion Illinois, 60099, United States
Covington Louisiana, 70433, United States
New Orleans Louisiana, 70121, United States
Shreveport Louisiana, 71103, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21201, United States
Silver Spring Maryland, 20902, United States
Silver Spring Maryland, 20910, United States
Boston Massachusetts, 02215, United States
Springfield Massachusetts, 01199, United States
Worcester Massachusetts, 01605, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55404, United States
Minneapolis Minnesota, 55455, United States
Billings Montana, 59101, United States
Neptune New Jersey, 07753, United States
Teaneck New Jersey, 07666, United States
Hawthorne New York, 10532, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10032, United States
New York New York, 10065, United States
Rochester New York, 14620, United States
Stony Brook New York, 11794, United States
Syracuse New York, 13210, United States
Charlotte North Carolina, 28204, United States
Canton Ohio, 44710, United States
Cincinnati Ohio, 45219, United States
Oklahoma City Oklahoma, 73104, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97227, United States
Tualatin Oregon, 97062, United States
Abington Pennsylvania, 19001, United States
Paoli Pennsylvania, 19301, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15224, United States
Pittsburgh Pennsylvania, 15232, United States
Wynnewood Pennsylvania, 19096, United States
Providence Rhode Island, 02905, United States
Charleston South Carolina, 29425, United States
Sioux Falls South Dakota, 57105, United States
Knoxville Tennessee, 37920, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37205, United States
Austin Texas, 78731, United States
Dallas Texas, 75246, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
San Antonio Texas, 78240, United States
The Woodlands Texas, 77380, United States
Tyler Texas, 75702, United States
Ogden Utah, 84405, United States
Charlottesville Virginia, 22903, United States
Hampton Virginia, 23666, United States
Newport News Virginia, 23606, United States
Norfolk Virginia, 23502, United States
Kennewick Washington, 99336, United States
Seattle Washington, 98104, United States
Seattle Washington, 98109, United States
Vancouver Washington, 98684, United States
Minsk , 22304, Belarus
Brasschaat , 2930, Belgium
Brugge , 8000, Belgium
Brussels , 1000, Belgium
Vancouver British Columbia, V5Z 4, Canada
London Ontario, N6A 4, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H2X 3, Canada
Montreal Quebec, H4A 3, Canada
Sherbrooke Quebec, J1H 5, Canada
Prague , 128 5, Czechia
Praha 8 - Liben , 180 8, Czechia
Copenhagen , DK- 2, Denmark
Dk-2730 Herlev , 2730, Denmark
Roskilde , 4000, Denmark
Helsinki , 00029, Finland
Kuopio , 70210, Finland
Tampere , 33520, Finland
Turku , 20520, Finland
Angers Cedex 02 , 49055, France
Avignon Cedex 9 , 84918, France
Besançon Cedex , 25030, France
Bordeaux , 33000, France
Caen , 14000, France
Clermont-Ferrand cedex , 63011, France
Dijon Cedex , 21079, France
Grenoble Cedex , 38000, France
La Tronche , 38700, France
Le Mans , 72000, France
Lille , 59000, France
Lyon cedex 08 , 69373, France
Lyon , 69008, France
Marseille Cedex 9 , 13273, France
Montpellier Cedex 5 , 34298, France
Montpellier , 34070, France
Nancy , 54100, France
Nantes , 44227, France
Nice Cedex 2 , 06189, France
Nîmes cedex 9 , 30029, France
Paris Cedex 05 , 75248, France
Paris Cedex 14 , 75014, France
Paris Cedex 15 , 75908, France
Paris Cedex 20 , 75970, France
Paris , 75014, France
Paris , 75020, France
Pierre-Benite Cedex , 69495, France
Pierre-Bénite cedex , 69495, France
Plerin-sur-mer , 22190, France
Poitiers cedex , 86021, France
Reims Cedex , 51056, France
Rennes Cedex , 35042, France
Saint-Priest en Jarez , 42271, France
Strasbourg Cedex , 67091, France
Toulouse Cedex 9 , 31059, France
Tours Cedex 1 , 37044, France
Villejuif , 94805, France
Ravensburg Baden-Wuerttemberg, 88212, Germany
Wolfsburg Niedersachsen, 38440, Germany
Muenster Nordrhein-Westfalen, 48149, Germany
Kiel Schleswig-Holstein, 24103, Germany
Berlin , 13125, Germany
Hamburg , 22457, Germany
Athens , 115 2, Greece
Athens , 11528, Greece
Athens , 12462, Greece
Haidari, Athens , 12462, Greece
Maroussi , 15123, Greece
Beer Sheva , 84101, Israel
Haifa , 31096, Israel
Haifa , 34362, Israel
Holon , 58220, Israel
Petach Tikva , 49414, Israel
Rehovot , 76100, Israel
Napoli Campania, 80131, Italy
Faenza (RA) Emilia-Romagna, 48018, Italy
Ravenna Emilia-Romagna, 48100, Italy
Bologna , 40138, Italy
Meldola , 47014, Italy
Amsterdam , 1105 , Netherlands
Groningen , 9700 , Netherlands
Maastricht , 6229 , Netherlands
Nijmegen , 6525 , Netherlands
Rotterdam , 3015 , Netherlands
Utrecht , 3584 , Netherlands
Kristiansand , 4632, Norway
Oslo , 0310, Norway
Tromso , 9019, Norway
Olsztyn , 10-22, Poland
Szczecin , 70-11, Poland
Warszawa , 02-78, Poland
Bucuresti , 02232, Romania
Cluj-Napoca , 40001, Romania
Cluj-Napoca , 40005, Romania
Constanta , 90059, Romania
Craiova , 20034, Romania
Timisoara , 30023, Romania
Avila , 05071, Spain
Badalona , 08916, Spain
Barcelona , 08036, Spain
Girona , 17007, Spain
Jaén , 23007, Spain
Madrid , 28046, Spain
San Sebastian de los Reyes , 28702, Spain
Santiago de Compostela , 15706, Spain
Toledo , 45007, Spain
Valencia , 46010, Spain
Zaragoza , 50009, Spain
Chernihiv , 14029, Ukraine
Kharkiv , 61024, Ukraine
Lviv , 79031, Ukraine
Portsmouth Hampshire, PO6 3, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Bebington, Wirral , CH63 , United Kingdom
Glasgow , G12 0, United Kingdom
London , SW36J, United Kingdom
Truro , TR1 3, United Kingdom
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