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NCT03602859Active, not recruitingPhase 3

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

A Randomized, Double-blind, Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

Source: ClinicalTrials.gov · Last updated 31 Dec 2025

Brief summary (registry, in English)

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 the progression-free survival (PFS) for participants receiving dostarlimab with SOC chemotherapy +/- bevacizumab followed by niraparib and dostarlimab maintenance +/- bevacizumab versus participants receiving SOC with chemotherapy followed by niraparib maintenance. This comparison will be investigated in participants of newly diagnosed stage III or IV advanced non-mucinous epithelial ovarian cancer participants and also to compare PFS of all participants with Stage III or IV high-grade non-mucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab (TSR-042), 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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1400 (actual)
First submitted
28 Jun 2018
Start date
11 Oct 2018
Primary completion date
31 Oct 2024
Lead sponsor
Tesaro, Inc.
NCT number
NCT03602859
EU CT number
2024-510605-28-00
EudraCT number
2018-000413-20

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1400
  • From 11 Oct 2018 to the primary completion date, 31 Oct 2024
  • 163 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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.
  • 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 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.
  • Prior treatment for high-grade nonmucinous epithelial ovarian, fallopian tube, or peritoneal cancer (immunotherapy, anti-cancer therapy, radiation therapy).
  • 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.

Other illness

  • Participant has low-grade or Grade 1 epithelial ovarian cancer.
  • 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).
  • 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 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 a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, niraparib, bevacizumab, dostarlimab, or their excipients.
  • 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).

Other

  • Participant has mucinous, germ cell, transitional cell, or undifferentiated tumor.
  • Participant has known active central nervous system metastases, carcinomatous meningitis, or both.
  • Participant is immunocompromised.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (163)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Algemeen Ziekenhuis klina
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BrasschaatBelgiumCompleted
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumCompleted
CHU Saint-Pierre
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BrusselsBelgiumCompleted
GSK Investigational Site
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MinskBelarusUnknown status
GSK Investigational Site
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LondonCanadaUnknown status
GSK Investigational Site
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MontrealCanadaUnknown status
GSK Investigational Site
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SherbrookeCanadaUnknown status
GSK Investigational Site
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TorontoCanadaUnknown status
GSK Investigational Site
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VancouverCanadaUnknown status
GSK Investigational Site
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WindsorCanadaUnknown status
Vseobecna fakultni nemocnice v Praze
Coordinator of this site? Confirm its status
PragueCzechiaCompleted
Fakultni nemocnice Bulovka
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PragueCzechiaCompleted
HELIOS Klinikum Berlin Buch GmbH
Coordinator of this site? Confirm its status
BerlinGermanyActive, not recruiting
Albertinen-Krankenhaus/Albertinen-Haus gGmbH
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HamburgGermanyActive, not recruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyActive, not recruiting
MVZ fuer Haematologie und Onkologie Ravensburg GmbH
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RavensburgGermanyActive, not recruiting
Klinikum Wolfsburg
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WolfsburgGermanyActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkCompleted
Region Hovedstaden
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HerlevDenmarkCompleted
Region Sjaelland
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RoskildeDenmarkCompleted
Hospital Germans Trias i Pujol
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BadalonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Institut Català d'Oncologia
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GironaSpainCompleted
Hospital Universitario de Jaén
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JaénSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario Infanta Sofia
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San Sebastián de los ReyesSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
Hospital Universitario de Toledo
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ToledoSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainCompleted
HUS-Yhtymae
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HelsinkiFinlandCompleted
Pohjois-Savon hyvinvointialue
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KuopioFinlandCompleted
Tampere University Hospital
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TampereFinlandCompleted
Turku University Hospital
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TurkuFinlandCompleted
Institut de Cancerologie de L'Ouest
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AngersFranceCompleted
Sainte Catherine Institut Du Cancer Avignon-Provence
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Avignon Cedex 9FranceCompleted
Besancon University Hospital Center
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Besancon CedexFranceCompleted
Clinique Tivoli-Ducos
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BordeauxFranceCompleted
Hospices Civils de Lyon
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BronFranceCompleted
Centre Francois Baclesse
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Caen Cedex 5FranceCompleted
Centre Hospitalier de Cholet
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CholetFranceCompleted
Centre Jean Perrin
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Clermont-FerrandFranceCompleted
Centr Georges Francois Leclerc
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DijonFranceCompleted
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceCompleted
Clinique Victor Hugo
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Le Mans Cedex 2FranceCompleted
Centre Oscar Lambret
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LilleFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
Hôpital Privé Jean Mermoz
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LyonFranceCompleted
Hopital De La Croix-Rousse
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Lyon Cedex 04FranceCompleted
Institut Paoli-Calmettes
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MarseilleFranceCompleted
Clinique Clementville
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MontpellierFranceCompleted
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceCompleted
Medipole De Nancy
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NancyFranceCompleted
L'Hopital Prive Du Confluent
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Nantes Cedex 2FranceCompleted
Centre Antoine Lacassagne
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Nice Cedex 2FranceCompleted
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Groupe Hospitalier Diaconesses Croix Saint-Simon
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ParisFranceCompleted
Institut Curie
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ParisFranceCompleted
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
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Paris Cedex 14FranceCompleted
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceCompleted
Hôpital Privé des Côtes d'Armor
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PlérinFranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
Institut Godinot
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ReimsFranceCompleted
Centre De Lutte Contre Le Cancer Eugene Marquis
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Rennes CedexFranceCompleted
Institut Curie
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Saint-CloudFranceCompleted
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceCompleted
Institut Universitaire Du Cancer Toulouse-Oncopole
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Toulouse Cedex 9FranceCompleted
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceCompleted
Institut Gustave Roussy
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VillejuifFranceCompleted
GSK Investigational Site
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GlasgowUnited KingdomUnknown status
GSK Investigational Site
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Metropolitan Borough of WirralUnited KingdomUnknown status
GSK Investigational Site
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PortsmouthUnited KingdomUnknown status
GSK Investigational Site
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SuttonUnited KingdomUnknown status
GSK Investigational Site
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TruroUnited KingdomUnknown status
Alexandra Hospital
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AthensGreeceCompleted
Areteio Hospital
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AthensGreeceCompleted
University General Hospital Attikon
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AthensGreeceCompleted
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.
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MaroussiGreeceCompleted
GSK Investigational Site
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BeershebaIsraelUnknown status
GSK Investigational Site
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HaifaIsraelUnknown status
GSK Investigational Site
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HolonIsraelUnknown status
GSK Investigational Site
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Petah TikvaIsraelUnknown status
GSK Investigational Site
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RehovotIsraelUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
Azienda Unita Sanitaria Locale Della Romagna
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FaenzaItalyCompleted
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyCompleted
Istituto Nazionale dei Tumori,
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NaplesItalyCompleted
Academisch Medisch Centrum
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AmsterdamNetherlandsCompleted
University Hospital Maastricht
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MaastrichtNetherlandsCompleted
Radboud Universitair Medisch Centrum (Radboudumc)
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NijmegenNetherlandsCompleted
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsCompleted
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsCompleted
Oslo University Hospital HF
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OsloNorwayCompleted
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie
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OlsztynPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
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SzczecinPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
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BucharestRomaniaActive, not recruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaActive, not recruiting
Medisprof S.R.L.
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Cluj-NapocaRomaniaActive, not recruiting
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaActive, not recruiting
GSK Investigational Site
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ChernihivUkraineUnknown status
GSK Investigational Site
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KharkivUkraineUnknown status
GSK Investigational Site
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LvivUkraineUnknown status
GSK Investigational Site
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AnchorageUnited StatesUnknown status
GSK Investigational Site
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AustinUnited StatesUnknown status
GSK Investigational Site
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BaltimoreUnited StatesUnknown status
GSK Investigational Site
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BillingsUnited StatesUnknown status
GSK Investigational Site
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BostonUnited StatesUnknown status
GSK Investigational Site
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CantonUnited StatesUnknown status
GSK Investigational Site
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CharlestonUnited StatesUnknown status
GSK Investigational Site
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CharlotteUnited StatesUnknown status
GSK Investigational Site
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CharlottesvilleUnited StatesUnknown status
GSK Investigational Site
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CincinnatiUnited StatesUnknown status
GSK Investigational Site
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CovingtonUnited StatesUnknown status
GSK Investigational Site
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DallasUnited StatesUnknown status
GSK Investigational Site
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EugeneUnited StatesUnknown status
GSK Investigational Site
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FarmingtonUnited StatesUnknown status
GSK Investigational Site
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Fort WorthUnited StatesUnknown status
GSK Investigational Site
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GainesvilleUnited StatesUnknown status
GSK Investigational Site
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GenevaUnited StatesUnknown status
GSK Investigational Site
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HartfordUnited StatesUnknown status
GSK Investigational Site
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HawthorneUnited StatesUnknown status
GSK Investigational Site
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HoustonUnited StatesUnknown status
GSK Investigational Site
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JacksonvilleUnited StatesUnknown status
GSK Investigational Site
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KennewickUnited StatesUnknown status
GSK Investigational Site
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KnoxvilleUnited StatesUnknown status
GSK Investigational Site
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Los AngelesUnited StatesUnknown status
GSK Investigational Site
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MinneapolisUnited StatesUnknown status
GSK Investigational Site
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NashvilleUnited StatesUnknown status
GSK Investigational Site
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Neptune CityUnited StatesUnknown status
GSK Investigational Site
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New OrleansUnited StatesUnknown status
GSK Investigational Site
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Newport BeachUnited StatesUnknown status
GSK Investigational Site
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New YorkUnited StatesUnknown status
GSK Investigational Site
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NorfolkUnited StatesUnknown status
GSK Investigational Site
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OgdenUnited StatesUnknown status
GSK Investigational Site
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Oklahoma CityUnited StatesUnknown status
GSK Investigational Site
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PaoliUnited StatesUnknown status
GSK Investigational Site
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PhiladelphiaUnited StatesUnknown status
GSK Investigational Site
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PhoenixUnited StatesUnknown status
GSK Investigational Site
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PittsburghUnited StatesUnknown status
GSK Investigational Site
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PortlandUnited StatesUnknown status
GSK Investigational Site
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ProvidenceUnited StatesUnknown status
GSK Investigational Site
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RochesterUnited StatesUnknown status
GSK Investigational Site
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San AntonioUnited StatesUnknown status
GSK Investigational Site
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ScarboroughUnited StatesUnknown status
GSK Investigational Site
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SeattleUnited StatesUnknown status
GSK Investigational Site
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ShreveportUnited StatesUnknown status
GSK Investigational Site
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Silver SpringUnited StatesUnknown status
GSK Investigational Site
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Sioux FallsUnited StatesUnknown status
GSK Investigational Site
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SpringfieldUnited StatesUnknown status
GSK Investigational Site
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Stony BrookUnited StatesUnknown status
GSK Investigational Site
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SyracuseUnited StatesUnknown status
GSK Investigational Site
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TeaneckUnited StatesUnknown status
GSK Investigational Site
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The WoodlandsUnited StatesUnknown status
GSK Investigational Site
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TucsonUnited StatesUnknown status
GSK Investigational Site
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TylerUnited StatesUnknown status
GSK Investigational Site
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WarrenvilleUnited StatesUnknown status
GSK Investigational Site
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Willow GroveUnited StatesUnknown status
GSK Investigational Site
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WorcesterUnited StatesUnknown status
GSK Investigational Site
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WynnewoodUnited StatesUnknown status
GSK Investigational Site
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ZionUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.