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NCT07549412RecruitingPhase 3

A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluridine/tipiracil (FTD-TPI) plus bevacizumab.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1020 (estimated)
First submitted
16 Apr 2026
Start date
6 May 2026
Primary completion date
16 Oct 2029
Lead sponsor
EMD Serono Research & Development Institute, Inc.
NCT number
NCT07549412
EU CT number
2025-524648-37-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1020
  • From 6 May 2026 to the primary completion date, 16 Oct 2029
  • 119 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

  • If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization

Other illness

  • Participant has a history of additional malignancy within 3 years before randomization
  • Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments

Other

  • Participants with known brain metastases
  • Other protocol defined exclusion criteria may apply

Who the study is looking for

  • Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting.
  • Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting
  • Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1
  • Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations
  • Other protocol defined inclusion criteria may apply

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

Full criteria on ClinicalTrials.gov

Sites (119)

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

SiteCityCountrySite status
Investigaciones Clinicas Moleculares ICM
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Ciudad Autonoma Buenos AiresArgentinaRecruiting
Instituto de Oncología de Rosario
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RosarioArgentinaRecruiting
Centro Oncologico de Excelencia
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San JuanArgentinaRecruiting
Centro de Investigaciones Medicas Tucuman
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San Miguel de TucumánArgentinaRecruiting
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
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SalzburgAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Noe LGA Gesundheit Thermenregion GmbH
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Wiener NeustadtAustriaRecruiting
Flinders Medical Centre
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Bedford ParkAustraliaRecruiting
Icon Cancer Centre Chermside
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ChermsideAustraliaRecruiting
Mater Misericordiae Ltd - PARENT
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South BrisbaneAustraliaRecruiting
GenesisCare -North Shore Oncology
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St LeonardsAustraliaRecruiting
Grand Hopital de Charleroi
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CharleroiBelgiumRecruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
The Ottawa Hospital Cancer Centre
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OttawaCanadaRecruiting
University Health Network - Princess Margaret Cancer Centre
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TorontoCanadaRecruiting
Peking Union Medical College Hospital
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BeijingChinaRecruiting
Sichuan Cancer Hospital
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ChengduChinaRecruiting
Sun Yat-sen University Cancer Center
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GuangzhouChinaRecruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine - 300173725
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HangzhouChinaRecruiting
The University of Hong Kong - 1
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Hong KongChinaRecruiting
Jiangsu Province Hospital
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NanjingChinaRecruiting
Guangxi Medical University Cancer Hospital
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NanningChinaRecruiting
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaRecruiting
Klinikum St. Marien Amberg
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AmbergGermanyRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Katholisches Klinikum Bochum gGmbH
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BochumGermanyRecruiting
Technische Universitaet Dresden
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DresdenGermanyRecruiting
Krankenhaus Nordwest GmbH
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Frankfurt am MainGermanyRecruiting
Haematologisch Onkologische Praxis Eppendorf
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HamburgGermanyRecruiting
Asklepios Kliniken Hamburg GmbH
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HamburgGermanyRecruiting
Universitaet Leipzig
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LeipzigGermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyRecruiting
Muenchen Klinik gGmbH
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MunichGermanyRecruiting
Aalborg University Hospital
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AalborgDenmarkNot yet recruiting
Region Hovedstaden
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HerlevDenmarkNot yet recruiting
Lillebaelt Hospital
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VejleDenmarkNot yet recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
ICO l'Hospitalet - Hospital Duran i Reynals
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario Virgen De Valme
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SevillaSpainRecruiting
Instituto Valenciano de Oncología (IVO)
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ValenciaSpainRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
Centre Francois Baclesse
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Caen Cedex 5FranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
Aberdeen Royal Infirmary - Dept of Oncology
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AberdeenUnited KingdomRecruiting
Sarah Cannon Research Institute UK
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LondonUnited KingdomRecruiting
The Christie Hospital - Dept of Oncology
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ManchesterUnited KingdomRecruiting
The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)
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Hong KongHong Kong SAR ChinaRecruiting
National Institute of Gastroenterology Saverio De Bellis Research Hospital
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Castellana GrotteItalyRecruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyRecruiting
Istituto Oncologico Veneto
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PadovaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
National Cancer Center Hospital
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ChūōkuJapanRecruiting
NHO Kyushu Cancer Center - 300175822
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FukuokaJapanRecruiting
Saitama Cancer Center - 300175812
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Kitaadachi-gunJapanRecruiting
Cancer Institute Hospital of JFCR
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KōtokuJapanRecruiting
Aichi Cancer Center Hospital
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NagoyaJapanRecruiting
Osaka International Cancer Institute
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OsakaJapanRecruiting
Kindai University Hospital
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Sakai-shiJapanRecruiting
Kanagawa Cancer Center - Dept of Gastroenterology
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YokohamaJapanRecruiting
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaRecruiting
National Cancer Center
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Goyang-siSouth KoreaRecruiting
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
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SeoulSouth KoreaRecruiting
Korea University Guro Hospital
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
The Catholic University of Korea, Seoul St. Maryâ
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SeoulSouth KoreaRecruiting
Amphia Ziekenhuis te Breda
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BredaNetherlandsNot yet recruiting
University Medical Center Groningen
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GroningenNetherlandsNot yet recruiting
Maastricht University Medical Center+ (MUMC+)
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MaastrichtNetherlandsNot yet recruiting
Jagiellonskie Centrum Innowacji Sp. z o.o.
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CracowPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandRecruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandRecruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandRecruiting
Umed Clinical Trials Sp. z o.o.
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LodzPolandRecruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
China Medical University Hospital
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TaichungTaiwanRecruiting
Chi Mei Hospital, Liouying
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TainanTaiwanRecruiting
National Cheng Kung University Hospital / Internal Medicine
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TainanTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Taipei Veterans General Hospital
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TaipeiTaiwanRecruiting
Texas Oncology, P.A. - Abilene - 300210366
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AbileneUnited StatesRecruiting
Illinois Cancer Specialists
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Arlington HeightsUnited StatesRecruiting
Texas Oncology South Austin
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AustinUnited StatesRecruiting
Texas Oncology - DFW
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BedfordUnited StatesRecruiting
Missouri Cancer Associates - 150518964
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ColumbiaUnited StatesRecruiting
Florida Cancer Specialists - Broadway
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Fort MyersUnited StatesRecruiting
Rocky Mountain Cancer Centers, LLP- Aurora
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Lone TreeUnited StatesRecruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Virginia Oncology Associates
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Newport NewsUnited StatesRecruiting
Illinois CancerCare PC
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PeoriaUnited StatesRecruiting
Blue Ridge Cancer Care - 300202915
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RoanokeUnited StatesRecruiting
Minnesota Oncology Hematology, P.A.
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Saint Louis ParkUnited StatesRecruiting
Texas Oncology - San Antonio
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San AntonioUnited StatesRecruiting
Springfield Clinic
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SpringfieldUnited StatesRecruiting
Profound Research LLC at Cancer and Leukemia Center
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Sterling HeightsUnited StatesRecruiting
Florida Cancer Specialists - St. Petersburg Bayfront
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St. PetersburgUnited StatesRecruiting
Texas Oncology, P.A. - Tyler
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TylerUnited StatesRecruiting
Florida Cancer Specialists East - FCS EAST - West Palm Beach
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West Palm BeachUnited StatesRecruiting
White Plains Hospital Medical and Wellness PRIME
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White PlainsUnited StatesRecruiting

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