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NCT03981796Active, not recruitingPhase 3

A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

A Phase 3, Randomized, Double-blind, Multicenter Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer (RUBY)

Source: ClinicalTrials.gov · Last updated 3 Sept 2025

Brief summary (registry, in English)

This is a 2 part study. Part 1 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo; and Part 2 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo in participants with recurrent or primary advanced (Stage III or IV) endometrial cancer.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
785 (actual)
First submitted
31 May 2019
Start date
18 Jul 2019
Primary completion date
26 Nov 2026
Lead sponsor
Tesaro, Inc.
NCT number
NCT03981796
EU CT number
2023-506551-23-00
EudraCT number
2019-001576-11

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 785
  • From 18 Jul 2019 to the primary completion date, 26 Nov 2026
  • 125 sites in 20 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 received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and:
    • has not had a recurrence or PD prior to first dose on the study OR
    • has had a recurrence or PD within 6 months of completing systemic anticancer therapy treatment prior to first dose on the study.
  • Participant has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-PD-ligand 1 (anti-PD-L1), or anti-PD-ligand 2 (anti-PD-L2) agent.
  • Participant has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days or \<5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter.
  • Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for \<3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.
  • Participant has not recovered adequately from AEs or complications from any major surgery prior to starting therapy.
  • Participant is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment.
  • Participant has received, or is scheduled to receive, a live vaccine within 30 days before first dose of study treatment, during study treatment, and for up to 180 days after receiving the last dose of study treatment.
    • Part 2 only:
  • Participant has received prior therapy with a poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor.
  • Participant is at increased bleeding risk due to concurrent conditions.

Other illness

  • Participant has had \>1 recurrence of endometrial cancer.
  • Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy.
  • Participant has clinically significant cardiovascular disease.
  • Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

Lab values

  • Participant has not recovered (that is \[i.e.\], to Grade \<=1 or to Baseline) from cytotoxic therapy induced AEs or has received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor \[GM-CSF\], or recombinant erythropoietin) within 21 days prior to the first dose of study drug.

Other

  • Part 1 and Part 2:
  • Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
  • Participant has participated in Part 1 of this study

Who the study is looking for

  • Part 1 and Part 2:
  • Female participant is at least 18 years of age.
  • Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
  • Participant must have primary Stage III or Stage IV disease or first recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination and meet at least one of the following criteria;
    • Participant has primary Stage IIIA to IIIC1 disease with presence of evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 based on Investigator's assessment. Lesions that are equivocal or can be representative of post-operative change should be biopsied and confirmed for the presence of tumor;
    • Participant has primary Stage IIIC1 disease with carcinosarcoma, clear cell, serous, or mixed histology (containing greater than or equal to \[\>=\] 10 percent carcinosarcoma, clear cell, or serous histology) regardless of presence of evaluable or measurable disease on imaging;
    • Participant has primary Stage IIIC2 or Stage IV disease regardless of the presence of evaluable or measurable disease;
    • Participant has first recurrent disease and is naïve to systemic anticancer therapy;
    • Participant has received prior neo-adjuvant/adjuvant systemic anticancer therapy and had a recurrence or progression of disease (PD) \>=6 months after completing treatment (first recurrence only).
  • Participant has an ECOG performance status of 0 or 1.
  • Participant has adequate organ function.
    • Part 2 only:
  • Participants must have normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP lesser than or equal to \[\<=\] 140 millimeter of mercury \[mmHg\] and diastolic BP \<=90 mmHg).
  • Participants must be able to take medication orally, by mouth (PO).

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

Full criteria on ClinicalTrials.gov

Sites (125)

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

SiteCityCountrySite status
Onze-Lieve-Vrouwziekenhuis
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AalstBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumActive, not recruiting
-
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GrodnoBelarusUnknown status
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MinskBelarusUnknown status
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CalgaryCanadaUnknown status
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MontrealCanadaUnknown status
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OttawaCanadaUnknown status
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QuébecCanadaUnknown status
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Sault Ste. MarieCanadaUnknown status
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TorontoCanadaUnknown status
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WinnipegCanadaUnknown status
Fakultni Nemocnice Brno
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Brno-StredCzechiaActive, not recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaActive, not recruiting
Hochtaunus-Kliniken gGmbH
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Bad HomburgGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyActive, not recruiting
MVZ fuer Haematologie und Onkologie Ravensburg GmbH
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RavensburgGermanyActive, not recruiting
Aalborg University Hospital
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AalborgDenmarkActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Region Hovedstaden
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HerlevDenmarkActive, not recruiting
Odense University Hospital
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Odense CDenmarkActive, not recruiting
Region Sjaelland
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RoskildeDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitario Reina Sofia
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CórdobaSpainCompleted
Hospital Universitario Donostia
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DonostiaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Hospital Universitario Virgen De Valme
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SevillaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Pohjois-Savon hyvinvointialue
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KuopioFinlandActive, not recruiting
Tampere University Hospital
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TampereFinlandActive, not recruiting
Turku University Hospital
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TurkuFinlandActive, not recruiting
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BrightonUnited KingdomUnknown status
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CambridgeUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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TruroUnited KingdomUnknown status
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.
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MaroussiGreeceCompleted
Euromedica General Clinic of Thessaloniki
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ThessalonikiGreeceCompleted
Orszagos Onkologiai Intezet
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Budapest XIIHungaryActive, not recruiting
University of Debrecen
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DebrecenHungaryActive, not recruiting
-
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AshkelonIsraelUnknown status
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BeershebaIsraelUnknown status
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HaifaIsraelUnknown status
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JerusalemIsraelUnknown status
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Petah TikvaIsraelUnknown status
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RehovotIsraelUnknown status
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Tel AvivIsraelUnknown status
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
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CandioloItalyActive, not recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
Azienda Sanitaria Locale Della Provincia Di Biella
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PonderanoItalyActive, not recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyActive, not recruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyActive, not recruiting
Ospedale Di Sassuolo S.p.A.
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SassuoloItalyActive, not recruiting
Azienda Provinciale Per I Servizi Sanitari
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TrentoItalyActive, not recruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyActive, not recruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsActive, not recruiting
Catharina Ziekenhuis Stichting
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EindhovenNetherlandsActive, not recruiting
Academisch Ziekenhuis Maastricht
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MaastrichtNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
Helse Bergen HF
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BergenNorwayActive, not recruiting
Oslo University Hospital HF
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OsloNorwayActive, not recruiting
Universitetssykehuset Nord-Norge HF
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TromsoeNorwayActive, not recruiting
St. Olavs hospital HF
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TrondheimNorwayActive, not recruiting
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
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BialystokPolandCompleted
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
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SzczecinPolandCompleted
Karolinska University Hospital
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SolnaSwedenActive, not recruiting
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting
-
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ChernihivUkraineUnknown status
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KharkivUkraineUnknown status
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AlbanyUnited StatesUnknown status
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AlbuquerqueUnited StatesUnknown status
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AtlantaUnited StatesUnknown status
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AugustaUnited StatesUnknown status
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AustinUnited StatesUnknown status
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BostonUnited StatesUnknown status
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CharlotteUnited StatesUnknown status
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CharlottesvilleUnited StatesUnknown status
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CincinnatiUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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CovingtonUnited StatesUnknown status
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DallasUnited StatesUnknown status
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Deerfield BeachUnited StatesUnknown status
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DetroitUnited StatesUnknown status
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DurhamUnited StatesUnknown status
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Fort WayneUnited StatesUnknown status
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HilliardUnited StatesUnknown status
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HinsdaleUnited StatesUnknown status
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IndianapolisUnited StatesUnknown status
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Iowa CityUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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KernersvilleUnited StatesUnknown status
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KnoxvilleUnited StatesUnknown status
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LebanonUnited StatesUnknown status
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LexingtonUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MineolaUnited StatesUnknown status
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Mount AiryUnited StatesUnknown status
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New OrleansUnited StatesUnknown status
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Newport BeachUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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Palo AltoUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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PittsburghUnited StatesUnknown status
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ProvidenceUnited StatesUnknown status
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Rio RanchoUnited StatesUnknown status
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RoanokeUnited StatesUnknown status
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SavannahUnited StatesUnknown status
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ScottsdaleUnited StatesUnknown status
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SeattleUnited StatesUnknown status
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ShreveportUnited StatesUnknown status
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SpringfieldUnited StatesUnknown status
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St LouisUnited StatesUnknown status
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The BronxUnited StatesUnknown status
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TucsonUnited StatesUnknown status
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TulsaUnited StatesUnknown status
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Willow GroveUnited StatesUnknown status
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Winston-SalemUnited StatesUnknown status
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ZionUnited StatesUnknown status
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AdapazarıTurkey (Türkiye)Unknown status
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AnkaraTurkey (Türkiye)Unknown status
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IstanbulTurkey (Türkiye)Unknown status

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