Clinical trial NCT05224141: Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)
Official title: A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination With Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination With Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYVIBE-008)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Small Cell Lung Carcinoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-02-04
Enrollment: 460
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: This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

Detailed description: With Amendment 4, the experimental Pembrolizumab/Vibostolimab arm (MK-7684A) was discontinued and all ongoing participants were offered an option to move to the comparator Atezolizumab monotherapy arm for the remainder of the study. There will be no further analyses of efficacy, and no European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer 13 module (EORTC QLQ-LC13) outcome measures will be reported.

Effective as of Amendment 5, participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from atezolizumab, but unable to access it as SOC outside the study, may continue on study and receive treatment with atezolizumab until discontinuation criteria are met.

Eligibility criteria: Inclusion Criteria:

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

* Has histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) in need of first-line therapy
* Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
* Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
* Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
* Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
* Has a predicted life expectancy of \>3 months

Exclusion Criteria:

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

* Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
* Has received prior treatment for Small Cell Lung Cancer (SCLC)
* Is expected to require any other form of antineoplastic therapy for SCLC while on study
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has a known history of, or active, neurologic paraneoplastic syndrome
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of Hepatitis B or known active Hepatitis C virus infection
* Has had an allogenic tissue/solid organ transplant
* Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention
* Has symptomatic ascites or pleural effusion

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 25 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 25 months
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 25 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 25 months
measure: Percentage of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 60 months
measure: Percentage of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to approximately 60 months
measure: Change From Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame: Baseline and up to approximately 60 months
measure: Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
timeFrame: Baseline and up to approximately 60 months
measure: Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
timeFrame: Baseline and up to approximately 60 months
measure: Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
timeFrame: Baseline and up to approximately 60 months
measure: Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
timeFrame: Baseline and up to approximately 60 months
measure: Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
timeFrame: Baseline and up to approximately 60 months
measure: TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
timeFrame: Baseline and up to approximately 60 months
measure: TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
timeFrame: Baseline and up to approximately 60 months
measure: TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
timeFrame: Baseline and up to approximately 60 months
measure: TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
timeFrame: Baseline and up to approximately 60 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Infirmary Cancer Care ( Site 0022)
state: Alabama
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group ( Site 0006)
state: California
city: Los Angeles
country: United States
facility: VA West Los Angeles Medical Center ( Site 0004)
state: California
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)
state: Florida
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology ( Site 0013)
state: Indiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute ( Site 0018)
state: Massachusetts
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan ( Site 0001)
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology ( Site 0003)
state: Mississippi
city: Lancaster
country: United States
facility: Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)
state: Pennsylvania
city: Blacksburg
country: United States
facility: Blue Ridge Cancer Care ( Site 0015)
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center ( Site 0019)
state: Virginia
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)
state: Buenos Aires
city: ABB
country: Argentina
facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)
state: Caba
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)
state: Caba
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0202)
state: Santa Fe
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario ( Site 0205)
state: Santa Fe
city: Penrith
country: Australia
facility: Nepean Hospital ( Site 2700)
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle ( Site 2703)
state: New South Wales
city: Frankston
country: Australia
facility: Frankston Hospital-Oncology and Haematology ( Site 2702)
state: Victoria
city: St Albans
country: Australia
facility: Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)
state: Oberosterreich
city: Linz
country: Austria
facility: Kepler Universitätsklinikum ( Site 0507)
state: Oberosterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz ( Site 0504)
state: Steiermark
city: Vienna
country: Austria
facility: Klinik Penzing-2. Lungenabteilung ( Site 0502)
state: Wien
city: Wien
country: Austria
facility: Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501)
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106)
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health ( Site 0102)
state: Ontario
city: Hefei
country: China
facility: Anhui Cancer Hospital ( Site 2915)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital ( Site 2921)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital-oncology department ( Site 2904)
state: Fujian
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 2916)
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2912)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 2922)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 2907)
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University ( Site 2913)
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital-GCP office ( Site 2909)
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University ( Site 2914)
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Chest Hospital-Oncology department ( Site 2900)
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 2908)
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer hospital ( Site 2923)
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital Sichuan University ( Site 2903)
state: Sichuan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital-Oncology ( Site 2919)
state: Zhejiang
city: Vaasa
country: Finland
facility: Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)
state: Pohjanmaa
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)
state: Pohjois-Pohjanmaa
city: Turku
country: Finland
facility: Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)
state: Varsinais-Suomi
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)
state: Bouches-du-Rhone
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)
state: Haute-Garonne
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané
state: Haute-Vienne
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)
state: Baden-Wurttemberg
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901)
state: Niedersachsen
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf-Onkologie ( Site 0903)
state: Schleswig-Holstein
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)
state: Thuringen
city: Athens
country: Greece
facility: Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)
state: Attiki
city: Athens
country: Greece
facility: Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)
state: Attiki
city: Athens
country: Greece
facility: Metropolitan Hospital ( Site 1001)
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion ( Site 1004)
state: Irakleio
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center ( Site 1000)
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)
state: Bacs-Kiskun
city: Gyor
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)
state: Gyor-Moson-Sopron
city: Törökbálint
country: Hungary
facility: Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)
state: Pest
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)
state: Somogy
city: Dublin
country: Ireland
facility: St. James's Hospital ( Site 1200)
city: Dublin
country: Ireland
facility: Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology ( Site 1301)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center-Oncology ( Site 1300)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-ONCOLOGY ( Site 1302)
city: Naples
country: Italy
facility: Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)
state: Campania
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)
state: Lombardia
city: Rozzano
country: Italy
facility: Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403)
state: Milano
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400)
state: Roma
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 3016)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 3002)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 3012)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 3014)
state: Fukuoka
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center ( Site 3015)
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 3006)
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa cancer center-Department of Thoracic Oncology ( Site 3004)
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 3001)
state: Miyagi
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital ( Site 3005)
state: Niigata
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 3009)
state: Osaka
city: Nagaizumi
country: Japan
facility: Shizuoka Cancer Center ( Site 3007)
state: Shizuoka
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research ( Site 3003)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 3013)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 3011)
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)
state: Jeonranamdo
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)
state: Taegu-Kwangyokshi
city: Daejeon
country: Korea, Republic of
facility: Chungnam national university hospital-Department of Internal Medicine ( Site 2802)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital-Internal Medicine ( Site 2803)
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)
state: Klaipedos Miestas
city: Vilnius
country: Lithuania
facility: National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)
state: Vilniaus Miestas
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)
city: Mexico
country: Mexico
facility: Arké SMO S.A. de C.V. ( Site 0401)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)
state: Jalisco
city: Guadalajara
country: Mexico
facility: Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)
state: Jalisco
city: Monterrey
country: Mexico
facility: iCan Oncology Center Centro Medico AVE ( Site 0406)
state: Nuevo Leon
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 0410)
city: Leeuwarden
country: Netherlands
facility: Medische Centrum Leeuwarden ( Site 1619)
state: Fryslan
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate ( Site 1606)
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht UMC+-Pulmonary disease ( Site 1602)
state: Limburg
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Hospital-Pulmonology ( Site 1605)
state: Noord-Brabant
city: Zwolle
country: Netherlands
facility: Isala, locatie Zwolle-Poli Longziekten ( Site 1612)
state: Overijssel
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum ( Site 1621)
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis ( Site 1618)
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703)
state: Podkarpackie
city: Prabuty
country: Poland
facility: Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706)
state: Pomorskie
city: Bystra
country: Poland
facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)
state: Slaskie
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED ( Site 1701)
state: Wielkopolskie
city: Poznan
country: Poland
facility: Med-Polonia Sp. z o. o. ( Site 1710)
state: Wielkopolskie
city: Lisbon
country: Portugal
facility: Champalimaud Foundation ( Site 1812)
state: Lisboa
city: Lisbon
country: Portugal
facility: Hospital CUF Descobertas ( Site 1815)
state: Lisboa
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813)
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810)
city: București
country: Romania
facility: MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905)
state: Bucuresti
city: București
country: Romania
facility: Centrul medical Focus ( Site 1903)
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca ( Site 1900)
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904)
state: Dolj
city: Craiova
country: Romania
facility: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 1901)
state: Dolj
city: Timișoara
country: Romania
facility: Cabinet Medical Oncomed ( Site 1902)
state: Timis
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102)
state: Madrid, Comunidad De
city: Málaga
country: Spain
facility: H.R.U Málaga - Hospital General-Oncology ( Site 2104)
state: Malaga
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103)
city: Bornova
country: Turkey
facility: Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402)
state: Izmir
city: Izmir, Karsiyaka
country: Turkey
facility: I.E.U. Medical Point Hastanesi-Oncology ( Site 2408)
state: Izmir
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi-oncology hospital ( Site 2409)
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 2406)
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital ( Site 2403)
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty-oncology ( Site 2400)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401)
city: Manchester
country: United Kingdom
facility: The Christie-Clinical Research Facility ( Site 2607)
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital ( Site 2602)
state: Hillingdon
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital-Oncology Research ( Site 2604)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: