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NCT07276399RecruitingPhase 3

A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer

A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants With Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
600 (estimated)
First submitted
1 Dec 2025
Start date
3 Dec 2025
Primary completion date
18 Jun 2029
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT07276399
EU CT number
2025-521917-24-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 600
  • From 3 Dec 2025 to the primary completion date, 18 Jun 2029
  • 206 sites in 22 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.

Other illness

  • Have an uncontrolled illness
  • Have untreated brain metastases or history of known presence of leptomeningeal disease
  • Have a history of clinically significant cardiovascular disease
  • Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase

Other

  • Inadequate organ or bone marrow function

Who the study is looking for

  • Be more than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater)
  • Have histologically or cytologically confirmed recurrent/metastatic (R/M) HNSCC that is considered incurable by local therapies: a. eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx; b. Must not have a primary tumor site of nasopharynx or primary tumor of unknown location; c. Must have documented local testing results per local regulations; d. Human papillomavirus (HPV) status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization (ISH). Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative
  • Be treatment-naive for systemic therapy in the R/M setting
  • Have an ECOG performance status of 0 or 1
  • Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1

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

Full criteria on ClinicalTrials.gov

Sites (206)

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

SiteCityCountrySite status
Burgenlaendische Krankenanstalten GmbH
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EisenstadtAustriaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
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SalzburgAustriaRecruiting
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Monash Medical Centre
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ClaytonAustraliaRecruiting
Liverpool Hospital
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LiverpoolAustraliaRecruiting
Peter MacCallum Cancer Centre
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MelbourneAustraliaRecruiting
St John of God Hospital Murdoch
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MurdochAustraliaRecruiting
GenesisCare
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St LeonardsAustraliaRecruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
Chu Helora
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La LouvièreBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Vitaz
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Sint-NiklaasBelgiumRecruiting
Fundacao Doutor Amaral Carvalho
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JaúBrazilRecruiting
Liga Norte Riograndense Contra o Cancer
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NatalBrazilRecruiting
Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilRecruiting
Funfarme Sjrp
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São José do Rio PretoBrazilRecruiting
Hospital Alemão Oswaldo Cruz
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São PauloBrazilRecruiting
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
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VitóriaBrazilRecruiting
Tongren Hospital Outpatient Bldg
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BeijingChinaRecruiting
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaRecruiting
Beijing Cancer Hospital
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BeijingChinaRecruiting
The Affiliated Hospital of Bengbu Medical College
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BengbuChinaRecruiting
Hunan Cancer Hospital
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ChangshaChinaRecruiting
The Second Xiangya Hospital of Central South University
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ChangshaChinaRecruiting
Sichuan Cancer Hospital
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ChengduChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
Sichuan Provincial Peoples Hospital
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ChengduChinaRecruiting
Chongqing Cancer Hospital
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ChongqingChinaRecruiting
Dongguan People's Hospital
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DongguanChinaRecruiting
Sun Yat-sen University Cancer Hospital
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GuangzhouChinaRecruiting
Zhejiang Cancer Hospital
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HangzhouChinaRecruiting
The Affiliated Cancer Hospital of Shandong First Medical University
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JinanChinaRecruiting
Yunnan Cancer Hospital
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KunmingChinaRecruiting
LinYi Cancer Hospital
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LinyiChinaRecruiting
Nanjing Drum Tower hospital
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NanjingChinaRecruiting
The Cancer Hospital Affiliated to Guangxi Medical University
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NanningChinaRecruiting
Shanghai East Hospital
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ShanghaiChinaRecruiting
Fudan Cancer Hospital
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ShanghaiChinaRecruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
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WuhanChinaRecruiting
Tongji Hospital Tongji Medical College of Hust
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WuhanChinaRecruiting
Wuhan University Zhongnan Hospital
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WuhanChinaRecruiting
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaRecruiting
Yibin Second People's Hospital
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YibinChinaRecruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaRecruiting
University Hospital Olomouc
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OlomoucCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Fakultni nemocnice v Motole
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PragueCzechiaRecruiting
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaRecruiting
Krajska Nemocnice T Bati a.s.
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ZlinCzechiaRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Justus-Liebig-Universitaet Giessen
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GiessenGermanyRecruiting
Klinikum Region Hannover GmbH
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HanoverGermanyRecruiting
Universitaet Leipzig
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LeipzigGermanyRecruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyRecruiting
Rostock University Medical Center
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RostockGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario de Navarra
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PamplonaSpainRecruiting
Fundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela
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Santiago De CompostelaSpainRecruiting
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainRecruiting
Hospital Universitario Miguel Servet
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ZaragozaSpainRecruiting
Sainte Catherine Institut Du Cancer Avignon-Provence
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Avignon Cedex 9FranceRecruiting
Clinique Victor Hugo
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Le MansFranceRecruiting
Centre Oscar Lambret
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LilleFranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Institut Curie
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ParisFranceRecruiting
Centre Henri Becquerel
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Rouen CedexFranceRecruiting
Institut De Cancerologie De L Ouest
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Saint-Herblain CedexFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
Addenbrooke's Hospital
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CambridgeUnited KingdomRecruiting
Castle Hill Hospital
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CottinghamUnited KingdomRecruiting
Western General Hospital
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EdinburghUnited KingdomRecruiting
Guy's and St Thomas' NHS Foundation Trust
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Greater LondonUnited KingdomRecruiting
Royal Surrey County Hospital NHS Trust
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GuildfordUnited KingdomRecruiting
St. Bartholomew's Hospital
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LondonUnited KingdomRecruiting
Royal Marsden Hospital (Chelsea)
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LondonUnited KingdomRecruiting
The Clatterbridge Cancer Centre
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Metropolitan Borough of WirralUnited KingdomRecruiting
Mount Vernon Cancer Centre
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NorthwoodUnited KingdomRecruiting
Nottingham City Hospital
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NottinghamUnited KingdomRecruiting
The Royal Marsden NHS Trust Sutton
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SuttonUnited KingdomRecruiting
Semmelweis University
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Budapest VIIIHungaryRecruiting
Orszagos Onkologiai Intezet
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Budapest XIIHungaryRecruiting
University of Debrecen
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DebrecenHungaryRecruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryRecruiting
University of Pecs
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PécsHungaryRecruiting
Nograd Varmegyei Szent Lazar Korhaz
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SalgótarjánHungaryRecruiting
Apollo Speciality Hospital, Chennai
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ChennaiIndiaRecruiting
Bhagwan Mahaveer Cancer Hospital & Research Centre
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JaipurIndiaRecruiting
Chittaranjan National Cancer Institute (CNCI)
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KolkataIndiaRecruiting
HealthCare Global HCG Manavata Cancer Centre
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NashikIndiaRecruiting
All India Institute of Medical Sciences
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New DelhiIndiaRecruiting
Kailash Cancer Hospital and Research Centre
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VadodaraIndiaRecruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyRecruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyRecruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Kansai Medical University Hospital
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HirakataJapanRecruiting
National Cancer Center Hospital East
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KashiwaJapanRecruiting
Aichi Cancer Center
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NagoyaJapanRecruiting
Hokkaido University Hospital
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SapporoJapanRecruiting
Tokyo Medical University Hospital
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ShinjukuJapanRecruiting
Shizuoka Cancer Center
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Sunto-gunJapanRecruiting
The Cancer Institute Hospital of JFCR
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TokyoJapanRecruiting
National Cancer Center Hospital
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TokyoJapanRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
CO de Chihuahua
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Chihuahua CityMexicoRecruiting
Act. Basada en la Inv. Del Ca
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GuadalajaraMexicoRecruiting
Gefarma (Atrys)
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Mexico CityMexicoRecruiting
P. y S. Oncologicos Acacias
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Mexico CityMexicoRecruiting
Cuidados Oncologicos
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QuerétaroMexicoRecruiting
Find My Cancer Cen de Inv Clin
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TijuanaMexicoRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsRecruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsRecruiting
Academisch Ziekenhuis Maastricht
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MaastrichtNetherlandsRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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GliwicePolandRecruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandRecruiting
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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LublinPolandRecruiting
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
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PoznanPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
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CoimbraPortugalRecruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalRecruiting
Hospital Cuf Descobertas S.A.
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LisbonPortugalRecruiting
Unidade Local de Saude do Algarve E.P.E.
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PortimaoPortugalRecruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalRecruiting
Unidade Local de Saúde de Gaia/Espinho, E. P. E
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Vila Nova de GaiaPortugalRecruiting
Spitalul Clinic Colțea
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BucharestRomaniaRecruiting
CardioMed S.R.L.
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Cluj-NapocaRomaniaRecruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaRecruiting
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaRecruiting
Institutul Regional de Oncologie Iasi
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IașiRomaniaRecruiting
Oncocenter Oncologie Clinica S.R.L
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TimișoaraRomaniaRecruiting
Changhua Christian Hospital
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ChanghuaTaiwanRecruiting
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
China Medical University Hospital
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TaichungTaiwanRecruiting
National Cheng Kung University Hospital
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TainanTaiwanRecruiting
Taipei Veterans General Hospital
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TaipeiTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Trinity Health St Joseph Mercy Ann Arbor
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Ann ArborUnited StatesRecruiting
Emory University
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AtlantaUnited StatesRecruiting
University of Maryland/Greenebaum Cancer Center
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BaltimoreUnited StatesRecruiting
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
Ironwood Cancer and Research Center
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ChandlerUnited StatesRecruiting
University of Virginia
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CharlottesvilleUnited StatesRecruiting
Rush University Medical Center Rush University Cancer Center Chicago
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ChicagoUnited StatesRecruiting
The University of Chicago Medical Center (UCMC)
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ChicagoUnited StatesRecruiting
University of Cincinnati
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CincinnatiUnited StatesRecruiting
Ohio State University
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ColumbusUnited StatesRecruiting
UT Southwestern Medical Center
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DallasUnited StatesRecruiting
Karmanos Cancer Institute
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DetroitUnited StatesRecruiting
Virginia Cancer Specialists
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FairfaxUnited StatesRecruiting
Florida Cancer Specialists - South
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Fort MyersUnited StatesRecruiting
Texas Oncology - San Antonio
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FredericksburgUnited StatesRecruiting
Providence St. Jude Medical Center
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FullertonUnited StatesRecruiting
Hartford Hospital
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HartfordUnited StatesRecruiting
Penn State Milton S. Hershey Medical Center
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HersheyUnited StatesRecruiting
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
Tennessee Cancer Specialists
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KnoxvilleUnited StatesRecruiting
Scripps Health
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La JollaUnited StatesRecruiting
University of Kentucky Medical Center
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LexingtonUnited StatesRecruiting
NHO Revive Research Institute, LLC
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LincolnUnited StatesRecruiting
University of California Los Angeles (UCLA).
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Los AngelesUnited StatesRecruiting
Valkyrie Clinical Trials
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Los AngelesUnited StatesRecruiting
Central Georgia Cancer Care
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MaconUnited StatesRecruiting
University of Miami - Sylvester Comprehensive Cancer Center
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MiamiUnited StatesRecruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
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MineolaUnited StatesRecruiting
Valkyrie Clinical Trials Murrieta
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MurrietaUnited StatesRecruiting
Vanderbilt University Medical Center
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NashvilleUnited StatesRecruiting
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesRecruiting
Yale Cancer Center
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New HavenUnited StatesRecruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
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New YorkUnited StatesRecruiting
Cancer Care Specialists of Central Illinois
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O'FallonUnited StatesRecruiting
AdventHealth Medical Group Oncology and Hematology at Orlando
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OrlandoUnited StatesRecruiting
Fox Chase Cancer Center
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PhiladelphiaUnited StatesRecruiting
University of Pennsylvania - Perelman Center for Advanced Medicine
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PhiladelphiaUnited StatesRecruiting
Oregon Health and Science University
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PortlandUnited StatesRecruiting
University of California - Davis
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SacramentoUnited StatesRecruiting
Huntsman Cancer Institute
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Salt Lake CityUnited StatesRecruiting
UCSF Medical Center at Mission Bay
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San FranciscoUnited StatesRecruiting
Stanford University Medical Center
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StanfordUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Florida Cancer Specialists - North Region
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St. PetersburgUnited StatesRecruiting
Bronx Veterans Affairs Medical Center
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The BronxUnited StatesRecruiting
Montefiore Medical Center
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The BronxUnited StatesRecruiting
University of Arizona Cancer Center
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TucsonUnited StatesRecruiting
UT Health East Texas HOPE Cancer Center
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TylerUnited StatesRecruiting
Texas Oncology - Central South
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WacoUnited StatesRecruiting
Florida Cancer Specialists - East
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West Palm BeachUnited StatesRecruiting
Carolina Cancer Research Center
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WilsonUnited StatesRecruiting

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