Clinical trial NCT06136559: A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
Official title: A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.


Eligibility criteria: Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
* Has at least 1 marker of disease burden.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.
* Has the ability to swallow and retain oral medication.
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization.
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.
* Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
* Has gastrointestinal (GI) dysfunction that may affect drug absorption.
* Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
* Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
* Has clinically significant cardiovascular disease.
* Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
* Has history of severe bleeding disorder.
* Has history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
* Has received any systemic anticancer therapy for CLL/SLL.
* Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
* Has active infection requiring systemic therapy.
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Primary outcomes:
measure: Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to ~33 months
measure: Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR
timeFrame: Up to ~104 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to ~104 months
measure: Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR
timeFrame: Up to ~104 months
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to ~104 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to ~104 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: USA Mitchell Cancer Institute ( Site 0014)
state: Alabama
city: Prescott
country: United States
facility: Arizona Oncology Associates - NAHOA ( Site 8007)
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center ( Site 0004)
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center ( Site 0003)
state: California
city: Denver
country: United States
facility: Saint Joseph Hospital ( Site 0026)
state: Colorado
city: Golden
country: United States
facility: Lutheran Medical Center ( Site 0027)
state: Colorado
city: Grand Junction
country: United States
facility: Intermountain Health St. Mary's Regional Hospital ( Site 0025)
state: Colorado
city: Norwich
country: United States
facility: Eastern CT Hematology & Oncology Associates ( Site 0033)
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South ( Site 7001)
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East ( Site 7002)
state: Florida
city: Fort Wayne
country: United States
facility: Parkview Research Center at Parkview Regional Medical Center ( Site 0002)
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa-Holden Comprehensive Cancer Center ( Site 0017)
state: Iowa
city: Edgewood
country: United States
facility: Saint Elizabeth Healthcare ( Site 0041)
state: Kentucky
city: Grand Rapids
country: United States
facility: Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)
state: Michigan
city: Saint Louis Park
country: United States
facility: Regions Hospital ( Site 0042)
state: Minnesota
city: Florham Park
country: United States
facility: Summit Medical Group Cancer Center ( Site 0007)
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute ( Site 0023)
state: New York
city: Broomall
country: United States
facility: Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)
state: Pennsylvania
city: York
country: United States
facility: Cancer Care Associates Of York ( Site 0005)
state: Pennsylvania
city: Austin
country: United States
facility: Texas Oncology - Central/South Texas ( Site 8008)
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders ( Site 0032)
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio ( Site 8006)
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas ( Site 8012)
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0015)
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University (VCU) Medical Center ( Site 0030)
state: Virginia
city: Spokane
country: United States
facility: Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
state: Washington
city: Madison
country: United States
facility: University Hospital and UW Health Clinics ( Site 0006)
state: Wisconsin
city: St Leonards
country: Australia
facility: Royal North Shore Hospital ( Site 2806)
state: New South Wales
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
state: Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven-Hematology ( Site 0200)
state: Vlaams-Brabant
city: São Paulo
country: Brazil
facility: Hospital 9 De Julho ( Site 2206)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer - INCA ( Site 2201)
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano-Americas Oncologia ( Site 2202)
city: Victoria
country: Canada
facility: BC Cancer Victoria ( Site 0109)
state: British Columbia
city: Brampton
country: Canada
facility: William Osler Health System ( Site 0103)
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus ( Site 0102)
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0106)
state: Quebec
city: Rimouski
country: Canada
facility: Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100)
state: Quebec
city: Santiago.
country: Chile
facility: Bradfordhill-Clinical Area ( Site 2310)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 2300)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)
state: Region M. De Santiago
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital ( Site 2001)
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital ( Site 2022)
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital-Hematology ( Site 2011)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital ( Site 2041)
state: Chongqing
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center ( Site 2028)
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital ( Site 2029)
state: Guangxi
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 2004)
state: Guangxi
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University ( Site 2024)
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital ( Site 2018)
state: Hainan
city: Wuhan
country: China
facility: Wuhan Union Hospital ( Site 2015)
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital-hematology department ( Site 2025)
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 2020)
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University ( Site 2010)
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital ( Site 2000)
state: Jiangsu
city: Suzhou
country: China
facility: The First Affliated Hospital of Suzhou University ( Site 2027)
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College ( Site 2013)
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University ( Site 2023)
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital ( Site 2009)
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University-Hematology ( Site 2030)
state: Jilin
city: Xian
country: China
facility: Shaanxi provincial people's hospital ( Site 2012)
state: Shaanxi
city: Jinan
country: China
facility: Shandong Cancer Hospital ( Site 2003)
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital ( Site 2033)
state: Shanxi
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019)
state: Tianjin
city: Tianjin
country: China
facility: Institute of hematology&blood disease hospital-Lymphoma ( Site 2005)
state: Tianjin
city: Urumqi
country: China
facility: Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014)
state: Xinjiang
city: Hangzhou
country: China
facility: The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 2017)
state: Zhejiang
city: Valledupar
country: Colombia
facility: Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405)
state: Cesar
city: Monteria
country: Colombia
facility: IMAT S.A.S ( Site 2401)
state: Cordoba
city: Cali
country: Colombia
facility: Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402)
state: Valle Del Cauca
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc ( Site 0303)
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Syd ( Site 0403)
state: Nordjylland
city: Roskilde
country: Denmark
facility: Roskilde Sygehus-Department of Hematology ( Site 0402)
state: Sjaelland
city: Odense C
country: Denmark
facility: Odense Universitetshospital-Department of Hematology ( Site 0401)
state: Syddanmark
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm. ( Site 0601)
state: Baden-Wurttemberg
city: Landshut
country: Germany
facility: VK&K Studien GbR ( Site 0607)
state: Bayern
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf ( Site 0603)
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606)
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: Universitätsklinikum Halle ( Site 0604)
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600)
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis ( Site 0701)
state: Anatoliki Makedonia Kai Thraki
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens ( Site 0700)
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko" ( Site 0704)
state: Attiki
city: Ioannina
country: Greece
facility: University Hospital of Ioannina ( Site 0702)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 3300)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)
city: Haifa
country: Israel
facility: Bnai Zion Medical Center ( Site 1505)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hemato-Oncology ( Site 1500)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1504)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-Hemato Oncology ( Site 1501)
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center. ( Site 1506)
city: Nagoya
country: Japan
facility: Nagoya University Hospital ( Site 1907)
state: Aichi
city: Maebashi
country: Japan
facility: Gunma University Hospital ( Site 1903)
state: Gunma
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 1900)
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital ( Site 1910)
state: Hyogo
city: Sendai
country: Japan
facility: Tohoku University Hospital ( Site 1901)
state: Miyagi
city: Sayama
country: Japan
facility: Kindai University Hospital ( Site 1909)
state: Osaka
city: Izumo
country: Japan
facility: Shimane University Hospital ( Site 1911)
state: Shimane
city: Koto
country: Japan
facility: Cancer Institute Hospital of JFCR ( Site 1906)
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 1905)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 1914)
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 1912)
city: Osaka
country: Japan
facility: Japanese Red Cross Osaka Hospital ( Site 1908)
city: Yamagata
country: Japan
facility: Yamagata University Hospital ( Site 1902)
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre ( Site 1604)
state: Kuala Lumpur
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang ( Site 1602)
state: Pulau Pinang
city: Kota Kinabalu
country: Malaysia
facility: Queen Elizabeth Hospital ( Site 1603)
state: Sabah
city: Ciudad de México
country: Mexico
facility: Centro de Infusion Superare ( Site 2602)
state: Distrito Federal
city: Ciudad de México
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V: ( Site 2608)
state: Distrito Federal
city: Hamilton
country: New Zealand
facility: Waikato Hospital-Haematology ( Site 3202)
state: Waikato
city: Auckland
country: New Zealand
facility: North Shore Hospital-Department of Haematology ( Site 3200)
city: Auckland
country: New Zealand
facility: Aotearoa Clinical Trials ( Site 3201)
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus ( Site 0902)
state: Akershus
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901)
city: Arequipa
country: Peru
facility: Centro Medico Monte Carmelo-Oncology ( Site 2706)
state: Ariqipa
city: Lima
country: Peru
facility: Clínica Anglo Americana ( Site 2701)
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii, Transplantacji Szp ( Site 1006)
state: Lubelskie
city: Krakow
country: Poland
facility: Pratia MCM Krakow ( Site 1007)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004)
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011)
state: Pomorskie
city: Słupsk
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013)
state: Pomorskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000)
state: Slaskie
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice ( Site 1009)
state: Slaskie
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005)
state: Warminsko-mazurskie
city: Lisbon
country: Portugal
facility: Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103)
state: Lisboa
city: Lisbon
country: Portugal
facility: Champalimaud Foundation ( Site 3102)
state: Lisboa
city: Vila Nova de Gaia
country: Portugal
facility: Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107)
state: Porto
city: Lisboa
country: Portugal
facility: Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104)
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106)
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100)
city: Centurion
country: South Africa
facility: Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits Clinical Research ( Site 1102)
state: Gauteng
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital-Clinical Haematology ( Site 1100)
state: Western Cape
city: Kuilsriver
country: South Africa
facility: Haemalife ( Site 1105)
state: Western Cape
city: Plumstead
country: South Africa
facility: Constantiaberg Haematology ( Site 1106)
state: Western Cape
city: L'Hospitalet Del Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207)
state: Barcelona
city: Barcelona
country: Spain
facility: HOSPITAL CLÍNIC DE BARCELONA ( Site 1202)
state: Cataluna
city: Majadahonda
country: Spain
facility: HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208)
state: Madrid, Comunidad De
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209)
state: Madrid
city: La Laguna
country: Spain
facility: hospital universitario de canarias ( Site 1205)
state: Santa Cruz De Tenerife
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206)
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201)
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 1302)
state: Stockholms Lan
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 1700)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 1701)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 1703)
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 1800)
state: Chiang Mai
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 1802)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801)
state: Krung Thep Maha Nakhon
city: Muang
country: Thailand
facility: Naresuan University Hospital ( Site 1804)
state: Phitsanulok
city: HatYai
country: Thailand
facility: Songklanagarind hospital ( Site 1803)
state: Songkhla
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407)
city: Antalya
country: Turkey
facility: Antalya Egitim ve Arastırma Hastanesi ( Site 1409)
city: Edirne
country: Turkey
facility: Trakya University-Balkan Onkoloji Hastanesi ( Site 1403)
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408)
city: İzmir
country: Turkey
facility: Ege Universitesi Hastanesi ( Site 1404)
city: Samsun
country: Turkey
facility: Ondokuz Mays Üniversitesi ( Site 1410)
city: Bristol
country: United Kingdom
facility: Southmead Hospital ( Site 3010)
state: Bristol, City Of
city: London
country: United Kingdom
facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)
state: London, City Of
city: Oxford
country: United Kingdom
facility: The Churchill Hospital ( Site 3007)
state: Oxfordshire
city: Newmarket
country: United Kingdom
facility: GenesisCare - Cambridge ( Site 3001)
state: Suffolk
city: Windsor
country: United Kingdom
facility: GenesisCare - Windsor ( Site 3002)
state: Windsor And Maidenhead
city: Barnet
country: United Kingdom
facility: Barnet Hospital ( Site 3005)
city: Leeds
country: United Kingdom
facility: St James's University Hospital ( Site 3004)
city: Nottingham
country: United Kingdom
facility: City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: