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NCT06750094RecruitingPhase 3

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
700 (estimated)
First submitted
20 Dec 2024
Start date
12 Dec 2024
Primary completion date
15 Dec 2027
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT06750094
EU CT number
2024-513853-66-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 700
  • From 12 Dec 2024 to the primary completion date, 15 Dec 2027
  • 248 sites in 26 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

  • Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  • Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments

Other illness

  • Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
  • Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI

Lab values

  • Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)

Other

  • Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor

Who the study is looking for

  • Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
  • Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing
  • Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
  • Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
  • Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
  • Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy

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

Full criteria on ClinicalTrials.gov

Sites (248)

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

SiteCityCountrySite status
Concord Hospital
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ConcordAustraliaCompleted
Warringal Private Hospital
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HeidelbergAustraliaRecruiting
Queen Elizabeth Hospital
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South WoodvilleAustraliaRecruiting
Western Health Sunshine Hospital
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St AlbansAustraliaRecruiting
Institut Jules Bordet
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AnderlechtBelgiumRecruiting
Antwerp University Hospital
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EdegemBelgiumRecruiting
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumRecruiting
Chu Helora
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La LouvièreBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
Fundacao Pio XII
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BarretosBrazilRecruiting
Fundacao Universidade de Caxias Do Sul
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Caxias do SulBrazilRecruiting
Fundacao Doutor Amaral Carvalho
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JaúBrazilRecruiting
Hospital Nossa Senhora da Conceicao S A
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Porto AlegreBrazilRecruiting
Hospital Santa Izabel, Santa Casa de Misericordia da Bahia
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SalvadorBrazilRecruiting
Funfarme Sjrp
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São José do Rio PretoBrazilRecruiting
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilRecruiting
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
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São PauloBrazilRecruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São PauloBrazilRecruiting
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
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VitóriaBrazilRecruiting
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaRecruiting
Beijing Cancer Hospital
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BeijingChinaRecruiting
Peking University First Hospital
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BeijingChinaRecruiting
The First Bethune Hospital of Jilin University
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ChangchunChinaRecruiting
Hunan Cancer Hospital
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ChangshaChinaRecruiting
West China Hospital of Sichuan University
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ChengduChinaRecruiting
Ganzhou Cancer Hospital
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GanzhouChinaRecruiting
Sun Yat-sen University Cancer Center
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GuangzhouChinaRecruiting
Guangdong Provincial People's Hospital
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GuangzhouChinaRecruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaRecruiting
The Second Affiliated Hospital of Zhejiang University
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HangzhouChinaRecruiting
Zhejiang Cancer Hospital
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HangzhouChinaRecruiting
Harbin Medical University Cancer Hospital
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HarbinChinaRecruiting
Huizhou Central People's Hospital
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HuizhouChinaRecruiting
Gansu Provincial Cancer Hospital
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LanzhouChinaRecruiting
The First Affiliated Hospital of NanChang University
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NanchangChinaRecruiting
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting
Liaoning Cancer Hospital and Institute
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ShenyangChinaRecruiting
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaRecruiting
Hubei Cancer Hospital
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WuhanChinaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Krankenhaus Nordwest GmbH
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Frankfurt am MainGermanyRecruiting
National Center for Tumor Diseases (NCT) Heidelberg
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HeidelbergGermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyRecruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyRecruiting
Hospital Universitario de Badajoz
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BadajozSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitari Dexeus Grupo Quironsalud
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Clinica Universidad de Navarra
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MadridSpainRecruiting
Instituto Multidisciplinar De Oncologia S.A.
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Regional de Málaga
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MálagaSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Sainte Catherine Institut Du Cancer Avignon-Provence
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Avignon Cedex 9FranceRecruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceRecruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceRecruiting
Birmingham Heartlands Hospital
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BirminghamUnited KingdomRecruiting
Castle Hill Hospital
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HullUnited KingdomRecruiting
St James University Hospital
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LeedsUnited KingdomRecruiting
St. Bartholomew's Hospital
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LondonUnited KingdomRecruiting
University College Hospital
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LondonUnited KingdomRecruiting
Royal Marsden Hospital
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LondonUnited KingdomRecruiting
Mount Vernon Cancer Centre
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NorthwoodUnited KingdomRecruiting
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaRecruiting
Prince of Wales Hospital
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ShatinHong Kong SAR ChinaRecruiting
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
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EgerHungaryCompleted
University of Pecs
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PécsHungaryCompleted
University of Szeged
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SzegedHungaryCompleted
Yitzhak Shamir Medical Center
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Beer YaakovIsraelRecruiting
Rambam Medical Center
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HaifaIsraelRecruiting
Hadassah medical Center
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JerusalemIsraelRecruiting
Rabin Medical Center
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Petah TikvaIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelRecruiting
Assuta MC
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Tel AvivIsraelRecruiting
Rajiv Gandhi Cancer Institute and Research Centre
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DelhiIndiaRecruiting
Asian Institute Of Gastroenterology
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HyderabadIndiaRecruiting
B P Poddar Hospital and Medical research Limited
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KolkataIndiaRecruiting
Tata Memorial Hospital
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MumbaiIndiaRecruiting
Safdarjung Hospital
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New DelhiIndiaRecruiting
Deenanath Mangeshkar Hospital and Research Centre
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PuneIndiaRecruiting
Mahamana Pandit Madan Mohan Malviya Cancer Centre
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VaranasiIndiaRecruiting
Christian medical
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VelloreIndiaRecruiting
Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS
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CandioloItalyRecruiting
ARNAS Garibaldi Di Catania
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CataniaItalyRecruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyRecruiting
Istituto Oncologico Veneto
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PadovaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Chiba Cancer Center
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ChibaJapanRecruiting
National Cancer Center Hospital
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ChūōkuJapanRecruiting
National Cancer Center Hospital East
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KashiwaJapanRecruiting
Aichi Cancer Center
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NagoyaJapanRecruiting
National Hospital Organization Osaka National Hospital
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OsakaJapanRecruiting
Osaka International Cancer Institute
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OsakaJapanRecruiting
Kindai University Hospital
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SakaiJapanRecruiting
Shizuoka Cancer Center
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ShizuokaJapanRecruiting
The University of Osaka Hospital
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SuitaJapanRecruiting
The Cancer Institute Hospital of JFCR
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TokyoJapanRecruiting
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaRecruiting
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Korea University Anam Hospital
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Centro Oncologico de Chihuahua
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Chihuahua CityMexicoRecruiting
Actualidad Basada en la Investigación del Cáncer
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GuadalajaraMexicoRecruiting
Instituto Nacional de Cancerologia
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Mexico CityMexicoRecruiting
Centro Oncologico Personalizado Cope S De R L De C V
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Mexico CityMexicoRecruiting
Hospital Universitario Dr. Jose Eleuterio González
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MonterreyMexicoRecruiting
Oncocenter
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Puebla CityMexicoRecruiting
Cuidados Oncologicos
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QuerétaroMexicoRecruiting
Health Pharma Queretaro SA de CV
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QuerétaroMexicoRecruiting
COI Centro Oncologico Internacional Tijuana
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TijuanaMexicoRecruiting
Hospital Pulau Pinang
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George TownMalaysiaRecruiting
Hospital Raja Permaisuri Bainun
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IpohMalaysiaRecruiting
Hospital Kuala Lumpur
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Kuala LumpurMalaysiaRecruiting
University Malaya Medical Centre
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Kuala LumpurMalaysiaRecruiting
Hospital Umum Sarawak
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KuchingMalaysiaRecruiting
Institut Kanser Negara Clinical Research Center
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PutrajayaMalaysiaRecruiting
Meander Medisch Centrum
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AmersfoortNetherlandsRecruiting
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
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AmsterdamNetherlandsRecruiting
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
Stichting Elisabeth-TweeSteden Ziekenhuis
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TilburgNetherlandsRecruiting
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
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Biala PodlaskaPolandRecruiting
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
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BialystokPolandRecruiting
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
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BrzozówPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Instytut Centrum Zdrowia Matki Polki
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LodzPolandRecruiting
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie
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OlsztynPolandRecruiting
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
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OpolePolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Pan American Center for Oncology Trials LLC
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San JuanPuerto RicoRecruiting
Centrul Medical Unirea S.R.L.
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BrasovRomaniaRecruiting
Memorial Healthcare International S R L
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BucharestRomaniaRecruiting
Mnt Healthcare Europe S.R.L.
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BucharestRomaniaRecruiting
Delta Health Care S.R.L
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BucharestRomaniaRecruiting
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
Pelican Impex S.R.L.
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OradeaRomaniaRecruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
Soedersjukhuset AB
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StockholmSwedenRecruiting
Uppsala University Hospital
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UppsalaSwedenRecruiting
Siriraj Hospital
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BangkokThailandRecruiting
Ramathibodi Hospital
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BangkokThailandRecruiting
Chiang Mai University
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Chiang MaiThailandRecruiting
Songklanagarind Hospital
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SongkhlaThailandRecruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
Taichung Veterans General 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
Linkou Chang Gung Memorial Hospital
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TaoyuanTaiwanRecruiting
Texas Oncology - West Texas
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AbileneUnited StatesRecruiting
University of Michigan Rogel Cancer Center
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Ann ArborUnited StatesRecruiting
Virginia Cancer Specialists
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ArlingtonUnited StatesRecruiting
Illinois Cancer Specialists
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Arlington HeightsUnited StatesRecruiting
University Cancer And Blood Center LLC
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AthensUnited StatesRecruiting
Grady Memorial Hospital
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AtlantaUnited StatesRecruiting
Piedmont Cancer Institute
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AtlantaUnited StatesRecruiting
Winship Cancer Institute, Emory University
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AtlantaUnited StatesRecruiting
University of Colorado Denver Anschultz Medical Campus
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AuroraUnited StatesRecruiting
CBCC Global Research
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BakersfieldUnited StatesRecruiting
MedStar Franklin Square Medical Center
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BaltimoreUnited StatesRecruiting
Mary Bird Perkins Cancer Center
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Baton RougeUnited StatesRecruiting
Gabrail Cancer Center
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CantonUnited StatesRecruiting
Ironwood Cancer and Research Center
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ChandlerUnited StatesRecruiting
Tennessee Oncology - Chattanooga
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ChattanoogaUnited StatesRecruiting
University Hospital of Cleveland
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ClevelandUnited StatesRecruiting
UT Southwestern Medical Center
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DallasUnited StatesRecruiting
Parkland Health and Hospital System
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DallasUnited StatesRecruiting
Texas Oncology - DFW
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DallasUnited StatesRecruiting
Rocky Mountain Cancer Centers
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DenverUnited StatesRecruiting
Henry Ford Hospital
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DetroitUnited StatesRecruiting
Astera Cancer Care
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East BrunswickUnited StatesRecruiting
Florida Cancer Specialists - South
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Fort MyersUnited StatesRecruiting
Frederick Health Hospital- James M Stockman Cancer Institute
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FrederickUnited StatesRecruiting
Banner MD Anderson Cancer Center
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GilbertUnited StatesRecruiting
Los Angeles Cancer Network
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GlendaleUnited StatesRecruiting
Cancer and Hematology Centers of Western Michigan, PC
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Grand RapidsUnited StatesRecruiting
Hattiesburg Clinic
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HattiesburgUnited StatesRecruiting
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
Franciscan Health
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IndianapolisUnited StatesRecruiting
University of Iowa Hospitals and Clinics
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Iowa CityUnited StatesRecruiting
St. Bernard's Medical Center
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JonesboroUnited StatesRecruiting
Providence Regional Cancer System
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LaceyUnited StatesRecruiting
Cancer and Blood Specialty Clinic
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Los AlamitosUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesRecruiting
Mount Sinai Medical Center Campus
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Miami BeachUnited StatesCompleted
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Perlmutter Cancer Center at NYU Long Island
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MineolaUnited StatesRecruiting
Vanderbilt University Medical Center
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NashvilleUnited StatesRecruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Tennessee Oncology
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NashvilleUnited StatesRecruiting
NYU Langone Medical Center NYU Hematology Associates
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New YorkUnited StatesRecruiting
Eastern Connecticut Hematology/Oncology Assoc.
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NorwichUnited StatesCompleted
Nebraska Cancer Specialists
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OmahaUnited StatesRecruiting
AdventHealth Cancer Institute
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OrlandoUnited StatesRecruiting
Alliance Cancer Specialists at Main Line
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Penn WynneUnited StatesRecruiting
Illinois CancerCare
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PeoriaUnited StatesRecruiting
Fox Chase Cancer Center
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PhiladelphiaUnited StatesRecruiting
Thomas Jefferson University
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PhiladelphiaUnited StatesRecruiting
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
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PittsburghUnited StatesRecruiting
Oregon Health and Science University
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PortlandUnited StatesRecruiting
Arizona Oncology Associates, PC - NAHOA
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PrescottUnited StatesCompleted
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
Richmond VA Medical Center
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RichmondUnited StatesRecruiting
Baylor Scott & White Medical Center
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Round RockUnited StatesRecruiting
Texas Oncology - San Antonio
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San AntonioUnited StatesRecruiting
UCLA
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Santa MonicaUnited StatesRecruiting
Providence Medical Foundation
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Santa RosaUnited StatesRecruiting
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesRecruiting
New York Cancer and Blood Specialists
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ShirleyUnited StatesRecruiting
Highlands Oncology Group
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SpringdaleUnited 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
Scott and White Memorial Hospital
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TempleUnited StatesRecruiting
Montefiore Einstein Comprehensive Cancer Center
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The BronxUnited StatesRecruiting
Torrance Memorial Physicians Network
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TorranceUnited StatesRecruiting
UT Health East Texas HOPE Cancer Center
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TylerUnited StatesRecruiting
Mission Cancer Blood
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WaukeeUnited StatesRecruiting
Florida Cancer Specialists - East
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West Palm BeachUnited StatesRecruiting
Cancer Center of Kansas
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WichitaUnited StatesRecruiting
University of Buffalo Kaleida Health Cancer Care
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WilliamsvilleUnited StatesRecruiting
Adana City Hospital
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AdanaTurkey (Türkiye)Recruiting
Ankara Bilkent Sehir Hastanesi
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AnkaraTurkey (Türkiye)Recruiting
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
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AnkaraTurkey (Türkiye)Recruiting
Gulhane Egitim ve Arastirma Hastanesi
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AnkaraTurkey (Türkiye)Recruiting
Gazi Universitesi Hastanesi
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AnkaraTurkey (Türkiye)Recruiting
Memorial Antalya Hospital
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AntalyaTurkey (Türkiye)Recruiting
Trakya University Medical Faculty
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EdirneTurkey (Türkiye)Recruiting
Bakirkoy Training and Research Hospital
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IstanbulTurkey (Türkiye)Recruiting
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
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IstanbulTurkey (Türkiye)Recruiting
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
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KonyaTurkey (Türkiye)Recruiting
Sakarya University Training and Research Hospital
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SakaryaTurkey (Türkiye)Recruiting

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