A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified July 2026 by Janssen Research & Development, LLC
Sponsor
Janssen Research & Development, LLC
Information Provided by (Responsible Party)
Janssen Research & Development, LLC
Clinicaltrials.gov Identifier
NCT06852222
Other Study ID Numbers:
75276617AML3001
First Submitted
February 24, 2025
First Posted
February 27, 2025
Last Update Posted
August 27, 2026
Last Verified
July 2026

ClinicalTrials.gov processed this data on August 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Leukemia, Myeloid, Acute
Drug: BleximenibDrug: Venetoclax (VEN)

Study Design

Study TypeInterventional
Actual Enrollment600 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy
Study Start DateJune 3, 2025
Actual Primary Completion Date2yrs 9mos from now
Actual Study Completion Date2yrs 11mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA)
Participants with acute myeloid leukemia (AML) will receive bleximenib in combination with venetoclax (VEN) and azacitidine (AZA) for 28-days treatment cycles and treatment will continue until progression or unacceptable toxicity.
Drug: Bleximenib
Bleximenib will be administered orally.
Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA)
Participants with AML will receive placebo in combination with VEN and AZA for 28-days treatment cycles, and treatment will continue until progression or unacceptable toxicity.
Drug: Venetoclax (VEN)
VEN will be administered orally.

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants who Achieve Complete Remission (CR)
    CR is defined as Bone marrow blasts less than (\<) 5 percent (%); Absence of circulating blasts; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (\>=) 1.0 \* 10\^9/Liter (1,000/microliter \[mcL\]); Platelet count \>= 100 \* 10\^9/L (100,000/mcL).
  2. Overall Survival (OS)
    Overall survival time is defined as the time duration from the date of randomization to death due to any cause.
Secondary Outcome Measures
  1. Event-free survival (EFS)
    EFS is defined as the time from randomization to treatment failure, relapse, or death due to any cause, whichever occurs first.
  2. Duration of CR
    Duration of CR will be estimated among responders from the date of initial documentation of CR, to the date of first documented evidence of relapse, or death due to any cause, whichever occurs first, respectively.
  3. Time to CR
    Time to CR is defined as time from randomization to first documented response.
  4. Rate of CR Without Measurable Residual Disease (MRD-)
    Rate of CR MRD- is defined as percentage of participants who have achieved CR without MRD.
  5. Percentage of Participants who Achieved Transfusion Independence
    Transfusion independence is defined as lack of requirement for red blood cell (RBC) and platelet transfusions during any 56-day period.
  6. Percentage of Participants with Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)
    Allo-HSCT rate is defined as the percentage of participants who have undergone allo-HSCT after randomization.
  7. Number of Participants with Adverse Events (AEs)
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
  8. Number of Participants with Abnormalities in Clinical Laboratory Parameters
    Participants with abnormalities in clinical laboratory parameters will be reported.
  9. Serum Concentration of Bleximenib
    Serum samples will be analyzed to determine concentrations of bleximenib.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion criteria:
Be 18 years of age or older at the time of informed consent
Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria
Ineligible for intensive chemotherapy based on the following criteria: a) \>= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) \>=18 to \<75 years of age with \>= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care
Participants must have adequate hepatic and renal function
A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment
Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion Criteria
Inclusion criteria:
Be 18 years of age or older at the time of informed consent
Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria
Ineligible for intensive chemotherapy based on the following criteria: a) \>= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) \>=18 to \<75 years of age with \>= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care
Participants must have adequate hepatic and renal function
A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment
Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study Exclusion criteria:
Diagnosis of acute promyelocytic leukemia (APL)
Known active leukemic involvement of the central nervous system (CNS)
Recipient of solid organ transplant
Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization
Active infectious hepatitis
Live, attenuated vaccine within 4 weeks of randomization
Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients

Contacts and Locations

Sponsors and CollaboratorsJanssen Research & Development, LLC
Locations
University of Alabama at Birmingham | Birmingham Alabama, United States, 35294Cancer Treatment Center of America Phoenix | Goodyear Arizona, United States, 85338The University of Arizona Cancer Center | Tucson Arizona, United States, 85724University of Arkansas at Little Rock | Little Rock Arkansas, United States, 72204City of Hope | Duarte California, United States, 91010Rocky Mountain Cancer Centers | Aurora Colorado, United States, 80012Medical Oncology Hematology Consultants, PA | Newark Delaware, United States, 19713Florida Cancer Specialists & Research Institute | Fort Myers Florida, United States, 33901Jupiter Research | Jupiter Florida, United States, 33458AdventHealth Medical Group Blood & Marrow Transplant at Orlando | Orlando Florida, United States, 32804Orlando Health Cancer Institute | Orlando Florida, United States, 32806Memorial Cancer Institute | Pembroke Pines Florida, United States, 33026Moffit Cancer center | Tampa Florida, United States, 33612Cleveland Clinic Florida | Weston Florida, United States, 33331University of Chicago Medicine | Chicago Illinois, United States, 60637Illinois Cancer Specialists | Niles Illinois, United States, 60714University of Kentucky Markey Cancer Center | Lexington Kentucky, United States, 40536UofL Health Brown Cancer Center | Louisville Kentucky, United States, 40202Norton Cancer Institute | Louisville Kentucky, United States, 40207Mary Bird Perkins Cancer Center | Baton Rouge Louisiana, United States, 70809Center for Cancer and Blood Disorders | Bethesda Maryland, United States, 20817Dana Farber Cancer Institute | Boston Massachusetts, United States, 02115Henry Ford Health System | Detroit Michigan, United States, 48202Trinity Health Michigan Heart - Ann Arbor Campus | Ypsilanti Michigan, United States, 48106Washington University in St Louis | St Louis Missouri, United States, 63130Dartmouth Hitchcock Medical Center | Lebanon New Hampshire, United States, 03756John Theurer Cancer Center at Hackensack University Medical Center | Hackensack New Jersey, United States, 07601Roswell Park Comprehensive Cancer Center | Buffalo New York, United States, 14263New York Presbyterian - Weill Cornell | New York New York, United States, 10065University of Rochester Medical Center | Rochester New York, United States, 14642Einstein-Montefiore Medical Center | The Bronx New York, United States, 10467Atrium Health | Charlotte North Carolina, United States, 28204Novant Health Charlotte | Charlotte North Carolina, United States, 28204Carolina Oncology Specialists | Charlotte North Carolina, United States, 28207Novant Health Winston Salem | Winston-Salem North Carolina, United States, 27106Atrium Health Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem North Carolina, United States, 27157Gabrail Cancer Center | Canton Ohio, United States, 44718Miami Valley Hospital South | Centerville Ohio, United States, 45459Oncology Hematology Care | Cincinnati Ohio, United States, 45226University Hospitals Cleveland Medical Center | Cleveland Ohio, United States, 44106Cleveland Clinic | Cleveland Ohio, United States, 44195Providence Portland Medical Center | Portland Oregon, United States, 97213Providence Oncology and Hematology Care Clinic Westside | Portland Oregon, United States, 97225Thomas Jefferson University | Philadelphia Pennsylvania, United States, 19107Fox Chase Cancer Center | Philadelphia Pennsylvania, United States, 19111University of Pittsburgh Medical Center | Pittsburgh Pennsylvania, United States, 15260University of Tennessee | Knoxville Tennessee, United States, 37920Vanderbilt Ingram Cancer Center | Nashville Tennessee, United States, 37232Baylor University Medical Center | Dallas Texas, United States, 75246Houston Methodist Cancer Center | Houston Texas, United States, 77030MD Anderson Cancer Center | Houston Texas, United States, 77030Texas Oncology - Northeast | Tyler Texas, United States, 75702Intermountain Healthcare LDS Hospital | Salt Lake City Utah, United States, 84143Virginia Commonwealth University - Massey Cancer Center | Richmond Virginia, United States, 23298Swedish Cancer Institute | Seattle Washington, United States, 98104Fred Hutchinson Cancer Center | Seattle Washington, United States, 98109Flinders Medical Centre | Bedford Park , Australia, 5042Royal Prince Alfred Hospital | Camperdown , Australia, 2050St Vincents Hospital Melbourne | Fitzroy , Australia, 3065St George Hospital | Kogarah , Australia, 2217Peter MacCallum Cancer Centre | Melbourne , Australia, 3000Princess Alexandra Hospital | Woolloongabba , Australia, 4102Kepler Universitatsklinikum GmbH | Linz , Austria, 4020Ordensklinikum Linz GmbH Elisabethinen | Linz , Austria, 4020Universitaetsklinikum Salzburg Landeskrankenhaus | Salzburg , Austria, 5020Medical University of Vienna Universitatsklinik fur Innere Medizin I | Vienna , Austria, 1090Wiener Gesundheitsverbund Klinik Hietzing | Vienna , Austria, 1130Klinikum Wels Grieskirchen | Wels , Austria, 4600AZ Sint-Jan | Bruges , Belgium, 8000UZ Antwerpen | Edegem , Belgium, 2650Ziekenhuis Oost-Limburg | Genk , Belgium, 3600Ghent University Hospital | Ghent , Belgium, 9000Chu Helora Hospital La Louviere Site Jolimont | La Louvière , Belgium, 7100Universitair Ziekenhuis Leuven | Leuven , Belgium, 3000Clinique Saint Pierre | Ottignies , Belgium, 1340Algemeen Ziekenhuis Delta | Roeselare , Belgium, 8800Fundacao Pio XII | Barretos , Brazil, 14780 070IDOR - Regional Brasilia | Brasília , Brazil, 70390 700Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer | Curitiba , Brazil, 81520-060Liga Norte Riograndense Contra O Cancer | Natal , Brazil, 59062 000Ministerio da Saude Instituto Nacional do Cancer | Rio de Janeiro , Brazil, 20230 130Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) | Rio de Janeiro , Brazil, 22775 001Real e Benemerita Associacao Portuguesa de Beneficencia | São Paulo , Brazil, 01323 010IDOR - Regional Sao Paulo | São Paulo , Brazil, 01401 002Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | São Paulo , Brazil, 05652 900Arthur J E Child Comprehensive Cancer Centre | Calgary Alberta, Canada, T2N 5G2Vancouver General Hospital | Vancouver British Columbia, Canada, V5Z 1N1Cancercare Manitoba | Winnipeg Manitoba, Canada, R3E 0V9Queen Elizabeth II Health Sciences Centre | Halifax Nova Scotia, Canada, B3H 2Y9Juravinski Cancer Centre | Hamilton Ontario, Canada, L8V 5C2London Health Sciences Centre Victoria Hospital | London Ontario, Canada, N6A 5W9Princess Margaret Cancer Centre University Health Network | Toronto Ontario, Canada, M5G 2M9CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont | Montreal Quebec, Canada, H1T 2M4Peking University First Hospital | Beijing , China, 100020Peking University People's Hospital | Beijing , China, 100044Peking University Third Hospital | Beijing , China, 100191The first Affiliated Hospital of Jilin University | Changchun , China, 130021Sichuan Provincial Peoples Hospital | Chengdu , China, 610032West China Hospital Si Chuan University | Chengdu , China, 610041The First Affiliated Hospital of Chongqing Medical University | Chongqing , China, 401147Sun Yat Sen University Cancer Center | Guangzhou , China, 510060The First Affiliated Hospital Zhejiang University College of Medicine | Hangzhou , China, 310003The First Affiliated Hospital of USTC Anhui Provincial Hospital | Hefei , China, 230001Qilu Hospital of Shandong University | Jinan , China, 250012The Second Hospital & Clinical Medical School Lanzhou University | Lanzhou , China, 730030The First Affiliated Hospital of NanChang University | Nanchang , China, 330006Zhongda Hospital Southeast University | Nanjing , China, 210009The First Affiliated Hospital of Guangxi Medical University | Nanning , China, 530021Shengjing Hospital Of China Medical University | Shenyang , China, 110055The Second People's Hospital of Shenzhen | Shenzhen , China, 518035First Affiliated Hospital SooChow University | Suzhou , China, 215005Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences | Tijian , China, 300020The First Affiliated Hospital of Wenzhou Medical University | Wenzhou , China, 325000Union Hospital Tongji Medical College of Huazhong University of Science and Technology | Wuhan , China, 430022TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology | Wuhan , China, 430030The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an , China, 710004The first affiliated hospital of xiamen university | Xiamen , China, 361003Henan Cancer Hospital | Zhengzhou , China, 450008Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika | Brno , Czechia, 625 00Fakultni nemocnice Hradec Kralove | Hradec Králové , Czechia, 500 05Fakultni Nemocnice Ostrava | Ostrava - Poruba , Czechia, 708 52Fakultni nemocnice Plzen | Pilsen , Czechia, 304 60Fakultni nemocnice Kralovske Vinohrady | Prague , Czechia, 100 00Ustav Hematologie A Krevni Transfuze | Prague , Czechia, 128 00Vseobecna Fakultní Nemocnice | Prague , Czechia, 128 08Aalborg University Hospital | Aalborg , Denmark, 9000Rigshospitalet | Copenhagen , Denmark, DK 2100Odense University Hospital | Odense , Denmark, 5000Zealand University Hospital | Roskilde , Denmark, 4000CHU d'Angers | Angers , France, 49933CHU de Clermont Ferrand - Site Estaing | Clermont-Ferrand , France, 63100Hopital Saint Vincent de Paul | Lille , France, 59020Institut Paoli Calmettes | Marseille , France, 13273CHU de Montpellier Hopital Saint Eloi | Montpellier , France, 34295CHU De Nice Hopital De l'Archet | Nice , France, 06202Hopital Saint Louis | Paris , France, 75010CHU Lyon Sud | Pierre-Bénite , France, 69310CHU Reims Hopital Robert Debre | Reims , France, 51100Chu Rennes Hopital Pontchaillou | Rennes , France, 35000Institut Universitaire du Cancer Toulouse Oncopole | Toulouse , France, 31100CHRU de Nancy - Hopitaux de Brabois | Vandœuvre Ies-Nancy , France, 54500Institut Gustave Roussy | Villejuif , France, 94805Klinikum Augsburg | Augsburg , Germany, 86156Universitaetsklinikum Koeln | Cologne , Germany, 50937Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden , Germany, 01307Universitaetsklinikum Frankfurt | Frankfurt , Germany, 60590Universitaetsklinikum Freiburg | Freiburg im Breisgau , Germany, 79106Universitaetsklinikum Hamburg Eppendorf | Hamburg , Germany, 20246Universitaetsklinikum Heidelberg | Heidelberg , Germany, 69120Universitaetsklinikum Schleswig Holstein Campus Kiel | Kiel , Germany, 24105Universitaetsklinikum Leipzig | Leipzig , Germany, 04103Klinikum der Universitaet Muenchen | München , Germany, 81377Universitaetsklinikum Wuerzburg | Würzburg , Germany, 97080University Hospital of Alexandroupolis | Alexandroupoli , Greece, 68100Evaggelismos Hospital | Athens , Greece, 106 76University General Hospital Attikon General Hospital Of West Attica H Agia Varvara | Chaïdári , Greece, 124 62University General Hospital of Ioannina | Ioannina , Greece, 455 00QGeneral University Hospital of Patras | Rio , Greece, 265 04Ahepa University General Hospital of Thessaloniki | Thessaloniki , Greece, 54636Geniko Nosokomeio Thessalonikis George Papanikolaou | Thessaloniki , Greece, 570 10Queen Mary Hospital | Hong Kong , Hong Kong, Semmelweis Egyetem | Budapest , Hungary, 1088Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely | Budapest , Hungary, 1097Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz | Győr , Hungary, 9024Pecsi Tudomanyegyetem Klinikai Kozpont | Pécs , Hungary, 7624SZTE Szent-Gyorgyi Albert Klinikai Kozpont | Szeged , Hungary, 6725Shamir Medical Center Assaf Harofeh | Beer Yaakov , Israel, 7033001Rambam Medical Center | Haifa , Israel, 3109601Carmel Medical Center | Haifa , Israel, 3436212Shaare Zedek Medical Center | Jerusalem , Israel, 9103102Hadassah University Hospita Ein Kerem | Jerusalem , Israel, 9112001Rabin Medical Center | Petah Tikva , Israel, 4941492Chaim Sheba Medical Center | Ramat Gan , Israel, 5262000Tel Aviv Sourasky Medical Center | Tel Aviv , Israel, 6423906ASST Papa Giovanni XXIII Bergamo | Bergamo , Italy, 24127A O U Sant Orsola Malpighi | Bologna , Italy, 40138Azienda Ospedaliera Spedali Civili di Brescia | Brescia , Italy, 25123Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola , Italy, 47014Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan , Italy, 20122ASST Grande Ospedale Metropolitano Niguarda | Milan , Italy, 20162Fondazione IRCCS Policlinico San Matteo | Pavia , Italy, 27100Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia | Perugia , Italy, 06132AST Pesaro e Urbino Ospedale San Salvatore | Pesaro , Italy, 61121Ospedale S. Maria Delle Croci | Ravenna , Italy, 48121Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria | Reggio Calabria , Italy, 89124IRCCS Istituto Clinico Humanitas | Rozzano , Italy, 20089Casa Sollievo Della Sofferenza IRCCS | San Giovanni Rotondo , Italy, 71013Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino | Torino , Italy, 10126Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital | Bunkyō City , Japan, 113 8677Kyushu University Hospital | Fukuoka , Japan, 812 8582Fukushima Medical University Hospital | Fukushima , Japan, 960 1295Gifu Municipal Hospital | Gifu , Japan, 500-8513Kanazawa University Hospital | Kanazawa , Japan, 920-8641Kobe City Medical Center General Hospital | Kobe , Japan, 650 0047National Hospital Organization Kumamoto Medical Center | Kumamoto , Japan, 860-0008Gunmaken Saiseikai Maebashi Hospital | Maebashi , Japan, 371-0821Nagoya University Hospital | Nagoya , Japan, 466 8560Okayama University Hospital | Okayama , Japan, 700 8558Japanese Red Cross Osaka Hospital | Osaka , Japan, 543 8555Aiiku Hospital | Sapporo , Japan, 064 0804Tohoku University Hospital | Sendai , Japan, 980 8574Nippon Medical School Hospital | Tokyo , Japan, 113 8603Yamagata University Hospital | Yamagata , Japan, 990 2331University of Fukui Hospital | Yoshida , Japan, 910-1193Centro de Investigacion Clinica Chapultepec | Mexico City , Mexico, 04100Instituto Nacional de Cancerologia | Mexico City , Mexico, 14080Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City , Mexico, 14080Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok , Poland, 15 276Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy | Bydgoszcz , Poland, 85-168Uniwersyteckie Centrum Kliniczne | Gdansk , Poland, 80 214Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach | Kielce , Poland, 25 734Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi | Lodz , Poland, 93 513Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw , Poland, 50 367Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos | Lisbon , Portugal, 1169 050Uls Santa Maria Hosp. Santa Maria | Lisbon , Portugal, 1649 028Uls Santo Antonio - Hosp. Santo Antonio | Porto , Portugal, 4099 001Instituto Portugues de Oncologia Porto | Porto , Portugal, 4200 072Uls Sao Joao - Hosp. Sao Joao | Porto , Portugal, 4200 319Chungnam National University Hospital | Daejeon , South Korea, 35015National Cancer Center | Goyang-si , South Korea, 10408Seoul National University Bundang Hospital | Gyeonggi-do , South Korea, 13620Seoul National University Hospital | Seoul , South Korea, 03080Asan Medical Center | Seoul , South Korea, 05505Samsung Medical Center | Seoul , South Korea, 06351The Catholic University of Korea Seoul St Marys Hospital | Seoul , South Korea, 137 701Hosp Univ A Coruna | A Coruña , Spain, 15006Hosp Univ Vall D Hebron | Barcelona , Spain, 08035Hosp. Clinic de Barcelona | Barcelona , Spain, 08036Hosp. de La Santa Creu I Sant Pau | Barcelona , Spain, 08041Hosp. San Pedro de Alcantara | Cáceres , Spain, 10003Hosp. de Jerez de La Frontera | Jerez de la Frontera , Spain, 11407Inst. Cat. Doncologia-H Duran I Reynals | L'Hospitalet de Llobregat , Spain, 08908Clinica Univ. de Navarra Madrid | Madrid , Spain, 28027Hosp. Univ. Ramon Y Cajal | Madrid , Spain, 28034Hosp. Univ. 12 de Octubre | Madrid , Spain, 28041Clinica Univ. de Navarra | Pamplona , Spain, 31008Hosp. Quiron Madrid Pozuelo | Pozuelo de Alarcón , Spain, 28223Hosp Clinico Univ de Salamanca | Salamanca , Spain, 37007Hosp. Univ. Marques de Valdecilla | Santander , Spain, 39008Hosp. Virgen Del Rocio | Seville , Spain, 41013Hosp. Univ. I Politecni La Fe | Valencia , Spain, 46026Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City , Taiwan, 833Chi Mei Medical Center Liouying Branch | Tainan , Taiwan, 736National Taiwan University Hospital | Taipei , Taiwan, 100Linkou Chang Gung Memorial Hospital | Taoyuan , Taiwan, 333Ankara Etlik Sehir Hastanesi | Ankara , Turkey (Türkiye), 06170Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital | Ankara , Turkey (Türkiye), 06200Ankara University School of Medicine Cebeci Hospital | Ankara , Turkey (Türkiye), 06590Memorial Antalya Hospital | Antalya , Turkey (Türkiye), 07025Koc University Medical Faculty | Istanbul , Turkey (Türkiye), 34010VM Medical Park Mersin Hospital | Mersin , Turkey (Türkiye), 33200Sakarya University Training and Research Hospital | Sakarya , Turkey (Türkiye), 54100Ondokuz Mayis University | Samsun , Turkey (Türkiye), 55139Royal Sussex County Hospital | Brighton , United Kingdom, BN2 5BEAddenbrookes Hospital | Cambridge , United Kingdom, CB2 0QQKent and Canterbury Hospital | Canterbury , United Kingdom, CT1 3NGColchester Hospital University NHS | Colchester , United Kingdom, CO4 5JLWestern General Hospital | Edinburgh , United Kingdom, EH4 2XUThe Clatterbridge Cancer Centre | Liverpool , United Kingdom, L7 8YAGuys' and St Thomas' NHS Trust | London , United Kingdom, SE1 9RTDerriford Hospital | Plymouth , United Kingdom, PL6 8DHWorthing Hospital | Worthing , United Kingdom, BN11 2DH
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC