Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)

Trial Title: Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)

NCT ID: NCT03924869

Condition: Non-Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pembrolizumab

Conditions: Keywords:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Intervention:

Intervention type: Radiation
Intervention name: Stereotactic Body Radiotherapy (SBRT)
Description: SBRT
Arm group label: SBRT+Pembolizumab
Arm group label: SBRT+Placebo

Intervention type: Biological
Intervention name: Pembrolizumab
Description: IV infusion
Arm group label: SBRT+Pembolizumab

Other name: MK-3475

Other name: KEYTRUDA®

Intervention type: Drug
Intervention name: Placebo
Description: IV infusion
Arm group label: SBRT+Placebo

Other name: Normal saline solution

Summary: The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC). The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution). As of protocol amendment 8, the study was stopped due to an interim analysis that did not support the study primary and key secondary endpoints.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Has previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded - Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented - Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 - Is able to receive SBRT and does not have an ultra-centrally located tumor - Has adequate organ function within 7 days prior to the start of study treatment - A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose - Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic - Has a radiation therapy plan approved by the central radiation therapy quality assurance vendor Exclusion Criteria: - Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], tumor necrosis factor receptor superfamily member 9 [CD137]) - Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast - Has received a live vaccine within 30 days prior to the first dose of study intervention - Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention administration - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. A prior NSCLC that occurred and was treated curatively at least 2 years prior to the date of the current diagnosis would be considered a separate primary lung cancer, and therefore an additional malignancy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast c carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. - Has a known hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis - Has a known history of Hepatitis B or known active Hepatitis C virus infection - Has an active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy - Has an active infection requiring systemic therapy - Has a known history of human immunodeficiency virus (HIV) infection - Has a known history of active tuberculosis (TB; Bacillus tuberculosis) - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose - Have not adequately recovered from major surgery or have ongoing surgical complications - Has had an allogenic tissue/solid organ transplant

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Alabama ( Site 0099)

Address:
City: Birmingham
Zip: 35233
Country: United States

Facility:
Name: Infirmary Cancer Care ( Site 3044)

Address:
City: Mobile
Zip: 36607
Country: United States

Facility:
Name: Alaska Oncology and Hematology ( Site 3063)

Address:
City: Anchorage
Zip: 99508
Country: United States

Facility:
Name: Banner MD Anderson Cancer Center ( Site 3029)

Address:
City: Gilbert
Zip: 85234
Country: United States

Facility:
Name: CARTI Cancer Center ( Site 3045)

Address:
City: Little Rock
Zip: 72205
Country: United States

Facility:
Name: USC Norris Comprehensive Cancer Center ( Site 0007)

Address:
City: Los Angeles
Zip: 90033
Country: United States

Facility:
Name: Veterans Affairs Palo Alto Health Care System ( Site 3039)

Address:
City: Palo Alto
Zip: 94304
Country: United States

Facility:
Name: National Jewish Health ( Site 0010)

Address:
City: Denver
Zip: 80206
Country: United States

Facility:
Name: Yale University ( Site 0011)

Address:
City: New Haven
Zip: 06510
Country: United States

Facility:
Name: Mid Florida Hematology and Oncology Center ( Site 0067)

Address:
City: Orange City
Zip: 32763
Country: United States

Facility:
Name: H. Lee Moffitt Cancer Center and Research Institute ( Site 0016)

Address:
City: Tampa
Zip: 33612
Country: United States

Facility:
Name: Goshen Center for Cancer Care ( Site 0022)

Address:
City: Goshen
Zip: 46526
Country: United States

Facility:
Name: Franciscan Health Indianapolis ( Site 0024)

Address:
City: Indianapolis
Zip: 46237
Country: United States

Facility:
Name: University of Kentucky School of Medicine & Hospitals ( Site 0026)

Address:
City: Lexington
Zip: 40536
Country: United States

Facility:
Name: Sinai Hospital of Baltimore ( Site 3011)

Address:
City: Baltimore
Zip: 21215
Country: United States

Facility:
Name: William E. Kahlert Regional Cancer Center ( Site 3031)

Address:
City: Westminster
Zip: 21157
Country: United States

Facility:
Name: Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007)

Address:
City: Boston
Zip: 02114
Country: United States

Facility:
Name: Mass General / North Shore Center for Outpatient Care ( Site 3040)

Address:
City: Danvers
Zip: 01923
Country: United States

Facility:
Name: University of Massachusetts ( Site 0029)

Address:
City: Worcester
Zip: 01655
Country: United States

Facility:
Name: Sanford Bemidji ( Site 0080)

Address:
City: Bemidji
Zip: 56601
Country: United States

Facility:
Name: University of Minnesota ( Site 0069)

Address:
City: Minneapolis
Zip: 55455
Country: United States

Facility:
Name: University of Missouri Hospital ( Site 3058)

Address:
City: Columbia
Zip: 65212
Country: United States

Facility:
Name: Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 3060)

Address:
City: Springfield
Zip: 65807
Country: United States

Facility:
Name: St. Vincent Healthcare Frontier Cancer Center ( Site 3012)

Address:
City: Billings
Zip: 59102
Country: United States

Facility:
Name: John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036)

Address:
City: Hackensack
Zip: 07601
Country: United States

Facility:
Name: Rutgers Cancer Institute of New Jersey ( Site 0043)

Address:
City: New Brunswick
Zip: 08903-2681
Country: United States

Facility:
Name: Hematology-Oncology Associates of CNY ( Site 3055)

Address:
City: East Syracuse
Zip: 13057
Country: United States

Facility:
Name: Mount Sinai Hospital ( Site 0046)

Address:
City: New York
Zip: 10029
Country: United States

Facility:
Name: Westchester Medical Center ( Site 3057)

Address:
City: Valhalla
Zip: 10595
Country: United States

Facility:
Name: White Plains Hospital ( Site 3014)

Address:
City: White Plains
Zip: 10601
Country: United States

Facility:
Name: Sanford Health Roger Maris Cancer Center ( Site 0079)

Address:
City: Fargo
Zip: 58102
Country: United States

Facility:
Name: Lehigh Valley Hospital- Cedar Crest ( Site 3005)

Address:
City: Allentown
Zip: 18103
Country: United States

Facility:
Name: St. Luke's University Health Network ( Site 3006)

Address:
City: Bethlehem
Zip: 18015
Country: United States

Facility:
Name: Penn State University Milton S. Hershey Medical Center ( Site 0064)

Address:
City: Hershey
Zip: 17033
Country: United States

Facility:
Name: Fox Chase Cancer Center ( Site 0051)

Address:
City: Philadelphia
Zip: 19111
Country: United States

Facility:
Name: Allegheny General Hospital ( Site 3028)

Address:
City: Pittsburgh
Zip: 15212
Country: United States

Facility:
Name: Lankenau Medical Center ( Site 3041)

Address:
City: Wynnewood
Zip: 19096
Country: United States

Facility:
Name: Sanford Cancer Center Oncology Clinic ( Site 0053)

Address:
City: Sioux Falls
Zip: 57104
Country: United States

Facility:
Name: Mountain States Health Alliance ( Site 3054)

Address:
City: Johnson City
Zip: 37604
Country: United States

Facility:
Name: University of Tennessee Medical Center Knoxville ( Site 3010)

Address:
City: Knoxville
Zip: 37920
Country: United States

Facility:
Name: Vanderbilt University Medical Center ( Site 0075)

Address:
City: Nashville
Zip: 37232
Country: United States

Facility:
Name: Cancer Care Northwest ( Site 0063)

Address:
City: Spokane Valley
Zip: 99216
Country: United States

Facility:
Name: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0206)

Address:
City: ABB
Zip: C1199ABB
Country: Argentina

Facility:
Name: Hospital Britanico de Buenos Aires ( Site 0204)

Address:
City: Buenos Aires
Zip: C1280AEB
Country: Argentina

Facility:
Name: Sanatorio Parque ( Site 0207)

Address:
City: Rosario
Zip: S2000DSV
Country: Argentina

Facility:
Name: Hospital Provincial del Centenario ( Site 0205)

Address:
City: Rosario
Zip: S2002KDS
Country: Argentina

Facility:
Name: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208)

Address:
City: Buenos Aires
Zip: 1012
Country: Argentina

Facility:
Name: Hospital Aleman ( Site 0200)

Address:
City: Buenos Aires
Zip: C1118AAT
Country: Argentina

Facility:
Name: Instituto Medico Especializado Alexander Fleming ( Site 0203)

Address:
City: Buenos Aires
Zip: C1426ANZ
Country: Argentina

Facility:
Name: CEMIC ( Site 0201)

Address:
City: Buenos Aires
Zip: C1431
Country: Argentina

Facility:
Name: Port Macquarie Base Hospital ( Site 2500)

Address:
City: Port Macquarie
Zip: 2444
Country: Australia

Facility:
Name: GenesisCare North Shore ( Site 2508)

Address:
City: St Leonards
Zip: 2065
Country: Australia

Facility:
Name: Royal Brisbane and Women s Hospital ( Site 2502)

Address:
City: Herston
Zip: 4029
Country: Australia

Facility:
Name: Icon Cancer Centre Hobart ( Site 2507)

Address:
City: Hobart
Zip: 7000
Country: Australia

Facility:
Name: Austin Health ( Site 2501)

Address:
City: Melbourne
Zip: 3084
Country: Australia

Facility:
Name: Keppler Universitatsklinikum ( Site 0806)

Address:
City: Linz
Zip: 4021
Country: Austria

Facility:
Name: Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804)

Address:
City: Graz
Zip: 8036
Country: Austria

Facility:
Name: Universitatsklinik LKH Innsbruck ( Site 0802)

Address:
City: Innsbruck
Zip: 6020
Country: Austria

Facility:
Name: Social Medical Center - Otto Wagner Hospital ( Site 0801)

Address:
City: Vienna
Zip: 1145
Country: Austria

Facility:
Name: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318)

Address:
City: Porto Alegre
Zip: 90050-170
Country: Brazil

Facility:
Name: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301)

Address:
City: Porto Alegre
Zip: 90610-000
Country: Brazil

Facility:
Name: Clínica de Oncologia Reichow ( Site 0319)

Address:
City: Blumenau
Zip: 89010-340
Country: Brazil

Facility:
Name: Hospital e Maternidade Celso Pierro ( Site 0313)

Address:
City: Campinas
Zip: 13060-904
Country: Brazil

Facility:
Name: Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305)

Address:
City: Rio de Janeiro
Zip: 20231-050
Country: Brazil

Facility:
Name: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300)

Address:
City: Sao Paulo
Zip: 01246-000
Country: Brazil

Facility:
Name: Hospital Paulistano - Amil Clinical Research ( Site 0316)

Address:
City: Sao Paulo
Zip: 01321-001
Country: Brazil

Facility:
Name: A.C. Camargo Cancer Center ( Site 0312)

Address:
City: Sao Paulo
Zip: 01509-900
Country: Brazil

Facility:
Name: Moncton Hospital - Horizon Health Network ( Site 0105)

Address:
City: Moncton
Zip: E1C 6Z8
Country: Canada

Facility:
Name: Kingston Health Sciences Centre ( Site 0100)

Address:
City: Kingston
Zip: K7L 2V7
Country: Canada

Facility:
Name: Trillium Health Partners - Credit Valley Hospital ( Site 0102)

Address:
City: Mississauga
Zip: L5M 2N1
Country: Canada

Facility:
Name: The Ottawa Hospital ( Site 0104)

Address:
City: Ottawa
Zip: K1H 8L6
Country: Canada

Facility:
Name: Sault Area Hospital ( Site 0101)

Address:
City: Sault Ste Marie
Zip: P6B 0A8
Country: Canada

Facility:
Name: Health Sciences North Research Institute ( Site 0107)

Address:
City: Sudbury
Zip: P3E 5J1
Country: Canada

Facility:
Name: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0110)

Address:
City: Montreal
Zip: H1T 2M4
Country: Canada

Facility:
Name: McGill University Health Centre ( Site 0113)

Address:
City: Montréal
Zip: H4A 3J1
Country: Canada

Facility:
Name: CHUS - Hopital Fleurimont ( Site 0111)

Address:
City: Sherbrooke
Zip: J1H 5N4
Country: Canada

Facility:
Name: CHU Poitiers ( Site 1109)

Address:
City: Poitiers
Zip: 86021
Country: France

Facility:
Name: CHU de Brest -Site Hopital Morvan ( Site 1100)

Address:
City: Brest
Zip: 29200
Country: France

Facility:
Name: Institut Bergonie ( Site 1102)

Address:
City: Bordeaux
Zip: 33076
Country: France

Facility:
Name: Institut Regional du Cancer de Montpellier - ICM ( Site 1108)

Address:
City: Montpellier
Zip: 34298
Country: France

Facility:
Name: CHU de Rouen ( Site 1113)

Address:
City: Rouen
Zip: 76000
Country: France

Facility:
Name: Hopital Sud du Amiens ( Site 1115)

Address:
City: Amiens
Zip: 80054
Country: France

Facility:
Name: Institut Curie ( Site 1112)

Address:
City: Paris
Zip: 75005
Country: France

Facility:
Name: Hopital Cochin ( Site 1107)

Address:
City: Paris
Zip: 75014
Country: France

Facility:
Name: A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114)

Address:
City: Paris
Zip: 75877
Country: France

Facility:
Name: Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1208)

Address:
City: Esslingen
Zip: 73730
Country: Germany

Facility:
Name: Universitaetsklinikum Heidelberg. ( Site 1204)

Address:
City: Heidelberg
Zip: 69126
Country: Germany

Facility:
Name: Universitaetsklinikum Erlangen ( Site 1209)

Address:
City: Erlangen
Zip: 91054
Country: Germany

Facility:
Name: UKGM Gießen/Marburg-Medical Clinic V ( Site 1210)

Address:
City: Gießen
Zip: 35392
Country: Germany

Facility:
Name: Pius Hospital Oldenburg ( Site 1202)

Address:
City: Oldenburg
Zip: 26121
Country: Germany

Facility:
Name: Universitaetsklinikum Essen ( Site 1201)

Address:
City: Essen
Zip: 45147
Country: Germany

Facility:
Name: Evangelisches Krankenhaus Hamm gGmbH ( Site 1205)

Address:
City: Hamm
Zip: 59063
Country: Germany

Facility:
Name: Charite Universitaetsmedizin Berlin ( Site 1207)

Address:
City: Berlin
Zip: 13353
Country: Germany

Facility:
Name: Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2311)

Address:
City: Kecskemét
Zip: 6000
Country: Hungary

Facility:
Name: Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314)

Address:
City: Pécs
Zip: 7624
Country: Hungary

Facility:
Name: CRU Hungary KFT ( Site 2309)

Address:
City: Miskolc
Zip: 3529
Country: Hungary

Facility:
Name: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312)

Address:
City: Szekesfehervar
Zip: 8000
Country: Hungary

Facility:
Name: Petz Aladar Megyei Oktato Korhaz ( Site 2305)

Address:
City: Gyor
Zip: 9024
Country: Hungary

Facility:
Name: Debreceni Egyetem Klinikai Kozpont ( Site 2301)

Address:
City: Debrecen
Zip: 4032
Country: Hungary

Facility:
Name: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2310)

Address:
City: Szolnok
Zip: 5004
Country: Hungary

Facility:
Name: Törökbálinti Tüdőgyógyintézet ( Site 2302)

Address:
City: Torokbalint
Zip: 2045
Country: Hungary

Facility:
Name: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307)

Address:
City: Kaposvar
Zip: 7400
Country: Hungary

Facility:
Name: Farkasgyepui Tudogyogyintezet ( Site 2313)

Address:
City: Farkasgyepu
Zip: 8582
Country: Hungary

Facility:
Name: Semmelweis University ( Site 2303)

Address:
City: Budapest
Zip: 1085
Country: Hungary

Facility:
Name: Orszagos Koranyi Pulmonologiai Intezet ( Site 2304)

Address:
City: Budapest
Zip: 1121
Country: Hungary

Facility:
Name: Orszagos Koranyi Pulmonologiai Intezet ( Site 2306)

Address:
City: Budapest
Zip: 1121
Country: Hungary

Facility:
Name: Orszagos Onkologiai Intezet ( Site 2308)

Address:
City: Budapest
Zip: 1122
Country: Hungary

Facility:
Name: Ospedale Santissima Annunziata ( Site 1303)

Address:
City: Chieti
Zip: 66100
Country: Italy

Facility:
Name: A.O. Universitaria Careggi ( Site 1301)

Address:
City: Firenze
Zip: 50134
Country: Italy

Facility:
Name: Policlinico di Modena ( Site 1306)

Address:
City: Modena
Zip: 41124
Country: Italy

Facility:
Name: Policlinico Agostino Gemelli ( Site 1302)

Address:
City: Roma
Zip: 00168
Country: Italy

Facility:
Name: Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1309)

Address:
City: Roma
Zip: 00185
Country: Italy

Facility:
Name: Aichi Cancer Center Hospital ( Site 2804)

Address:
City: Nagoya
Zip: 464-8681
Country: Japan

Facility:
Name: National Cancer Center Hospital East ( Site 2800)

Address:
City: Kashiwa
Zip: 2778577
Country: Japan

Facility:
Name: Kurume University Hospital ( Site 2815)

Address:
City: Kurume
Zip: 830-0011
Country: Japan

Facility:
Name: Kobe Minimally Invasive Cancer Center ( Site 2811)

Address:
City: Kobe
Zip: 650-0046
Country: Japan

Facility:
Name: University of Tsukuba Hospital ( Site 2809)

Address:
City: Tsukuba
Zip: 305-8576
Country: Japan

Facility:
Name: Sendai Kousei Hospital ( Site 2814)

Address:
City: Sendai
Zip: 980-0873
Country: Japan

Facility:
Name: Kansai Medical University Hospital ( Site 2808)

Address:
City: Hirakata
Zip: 573-1191
Country: Japan

Facility:
Name: Osaka Medical and Pharmaceutical University Hospital ( Site 2813)

Address:
City: Takatsuki
Zip: 5698686
Country: Japan

Facility:
Name: University of Yamanashi Hospital ( Site 2807)

Address:
City: Chuo
Zip: 409-3898
Country: Japan

Facility:
Name: Chiba University Hospital ( Site 2806)

Address:
City: Chiba
Zip: 260-8677
Country: Japan

Facility:
Name: National Hospital Organization Kyushu Cancer Center ( Site 2816)

Address:
City: Fukuoka
Zip: 811-1395
Country: Japan

Facility:
Name: Hiroshima University Hospital ( Site 2810)

Address:
City: Hiroshima
Zip: 734-8551
Country: Japan

Facility:
Name: Niigata Cancer Center Hospital ( Site 2801)

Address:
City: Niigata
Zip: 951-8566
Country: Japan

Facility:
Name: Osaka International Cancer Institute ( Site 2812)

Address:
City: Osaka
Zip: 541-8567
Country: Japan

Facility:
Name: Tokyo Metropolitan Komagome Hospital ( Site 2802)

Address:
City: Tokyo
Zip: 113-8677
Country: Japan

Facility:
Name: The Cancer Institute Hospital of JFCR ( Site 2803)

Address:
City: Tokyo
Zip: 135-8550
Country: Japan

Facility:
Name: Showa University Hospital ( Site 2805)

Address:
City: Tokyo
Zip: 142-8666
Country: Japan

Facility:
Name: Chungbuk National University Hospital ( Site 2605)

Address:
City: Cheongju-si
Zip: 28644
Country: Korea, Republic of

Facility:
Name: National Cancer Center ( Site 2604)

Address:
City: Goyang-si
Zip: 10408
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea St. Vincent s Hospital ( Site 2606)

Address:
City: Gyeonggi-do
Zip: 16247
Country: Korea, Republic of

Facility:
Name: Seoul National University Hospital ( Site 2600)

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center ( Site 2603)

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Ziekenhuis Rijnstate ( Site 1405)

Address:
City: Arnhem
Zip: 6815 AD
Country: Netherlands

Facility:
Name: Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407)

Address:
City: Hilversum
Zip: 1213 XZ
Country: Netherlands

Facility:
Name: Meander Medisch Centrum-Studie Team Oncologie ( Site 1403)

Address:
City: Amersfoort
Zip: 3813 TZ
Country: Netherlands

Facility:
Name: Auckland City Hospital ( Site 2900)

Address:
City: Grafton
Zip: 1023
Country: New Zealand

Facility:
Name: St Olavs Hospital ( Site 1504)

Address:
City: Trondheim
Zip: 7030
Country: Norway

Facility:
Name: Helse Bergen HF Haukeland Universitetssykehus ( Site 1502)

Address:
City: Bergen
Zip: 5021
Country: Norway

Facility:
Name: Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500)

Address:
City: Oslo
Zip: 0450
Country: Norway

Facility:
Name: Centrum Onkologii im. prof. Franciszka ukaszczyka-Ambulatorium Chemioterapii ( Site 2407)

Address:
City: Bydgoszcz
Zip: 85-796
Country: Poland

Facility:
Name: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402)

Address:
City: Lodz
Zip: 93-513
Country: Poland

Facility:
Name: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400)

Address:
City: Krakow
Zip: 31-826
Country: Poland

Facility:
Name: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Facility:
Name: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403)

Address:
City: Gliwice
Zip: 44-101
Country: Poland

Facility:
Name: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404)

Address:
City: Olsztyn
Zip: 10-228
Country: Poland

Facility:
Name: Amethyst Radiotherapy Center-Oncologie Medicala ( Site 3201)

Address:
City: Florești
Zip: 407280
Country: Romania

Facility:
Name: Institutul Oncologic-Oncologie Medicala ( Site 3202)

Address:
City: Cluj
Zip: 400015
Country: Romania

Facility:
Name: Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014)

Address:
City: Chelyabinsk
Zip: 454087
Country: Russian Federation

Facility:
Name: GUZ Lipetsk Regional Oncology Dispensary ( Site 2010)

Address:
City: Lipetsk
Zip: 398005
Country: Russian Federation

Facility:
Name: N.N.Blokhin Russian Cancer Research center ( Site 2013)

Address:
City: Moscow
Zip: 115478
Country: Russian Federation

Facility:
Name: Russian Scientific Center of Roentgenoradiology ( Site 2011)

Address:
City: Moscow
Zip: 117997
Country: Russian Federation

Facility:
Name: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000)

Address:
City: Saint-Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: Medical institute named after Berezin Sergey ( Site 2009)

Address:
City: St. Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: Sverdlovsk Regional Oncology Hospital ( Site 2012)

Address:
City: Ekaterinburg
Zip: 620036
Country: Russian Federation

Facility:
Name: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001)

Address:
City: Kazan
Zip: 420029
Country: Russian Federation

Facility:
Name: Hospital Universitario Quiron Madrid ( Site 1601)

Address:
City: Pozuelo de Alarcon
Zip: 28223
Country: Spain

Facility:
Name: Hospital Universitario La Fe ( Site 1603)

Address:
City: Valencia
Zip: 46206
Country: Spain

Facility:
Name: Hospital General Universitari Vall d Hebron ( Site 1602)

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital General Universitario Gregorio Maranon ( Site 1604)

Address:
City: Madrid
Zip: 28009
Country: Spain

Facility:
Name: Hopitaux Universitaires de Geneve HUG ( Site 1706)

Address:
City: Geneva
Zip: 1211
Country: Switzerland

Facility:
Name: Universitaetsspital Zuerich ( Site 1700)

Address:
City: Zuerich
Zip: 8091
Country: Switzerland

Facility:
Name: Tri-Service General Hospital ( Site 3300)

Address:
City: Taipei City
Zip: 114
Country: Taiwan

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3304)

Address:
City: Kaohsiung
Zip: 807
Country: Taiwan

Facility:
Name: Taipei Medical University Hospital ( Site 3303)

Address:
City: Taipei
Zip: 110301
Country: Taiwan

Facility:
Name: Taipei Veterans General Hospital ( Site 3301)

Address:
City: Taipei
Zip: 11217
Country: Taiwan

Facility:
Name: Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105)

Address:
City: Adana
Zip: 01250
Country: Turkey

Facility:
Name: Hacettepe University Medical Faculty ( Site 2100)

Address:
City: Ankara
Zip: 06100
Country: Turkey

Facility:
Name: Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101)

Address:
City: Ankara
Zip: 06200
Country: Turkey

Facility:
Name: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2116)

Address:
City: Istanbul
Zip: 34722
Country: Turkey

Facility:
Name: Kartal Training and Research Hospital ( Site 2102)

Address:
City: Istanbul
Zip: 34890
Country: Turkey

Facility:
Name: I.E.U. Medical Point Hastanesi ( Site 2115)

Address:
City: Izmir
Zip: 35520
Country: Turkey

Facility:
Name: Erciyes University Medical Faculty ( Site 2109)

Address:
City: Kayseri
Zip: 38030
Country: Turkey

Facility:
Name: Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114)

Address:
City: Sakarya
Zip: 54290
Country: Turkey

Facility:
Name: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207)

Address:
City: Dnipro
Zip: 49055
Country: Ukraine

Facility:
Name: Regional Centre of Oncology-Thoracic organs ( Site 2202)

Address:
City: Kharkiv
Zip: 61070
Country: Ukraine

Facility:
Name: Ukrainian Center of Tomotherapy ( Site 2206)

Address:
City: Kropyvnitskiy
Zip: 25011
Country: Ukraine

Facility:
Name: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2205)

Address:
City: Kapitanivka Village
Zip: 08111
Country: Ukraine

Facility:
Name: Medical Center Asklepion LLC ( Site 2208)

Address:
City: Khodosivka
Zip: 08173
Country: Ukraine

Facility:
Name: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203)

Address:
City: Kyiv
Zip: 03126
Country: Ukraine

Facility:
Name: Kyiv City Clinical Oncology Centre ( Site 2200)

Address:
City: Kyiv
Zip: 03115
Country: Ukraine

Facility:
Name: University Hospitals Bristol NHS Foundation Trust ( Site 1802)

Address:
City: Bristol
Zip: BS2 8ED
Country: United Kingdom

Facility:
Name: Royal Free London NHS Foundation Trust ( Site 1813)

Address:
City: London
Zip: NW3 2QG
Country: United Kingdom

Facility:
Name: Weston Park Hospital ( Site 1801)

Address:
City: Sheffield
Zip: S10 2SJ
Country: United Kingdom

Facility:
Name: Clatterbridge Cancer Center NHS FT ( Site 1800)

Address:
City: Liverpool
Zip: L7 8YA
Country: United Kingdom

Facility:
Name: Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809)

Address:
City: Preston
Zip: PR2 9HT
Country: United Kingdom

Facility:
Name: Leicester Royal Infirmary ( Site 1811)

Address:
City: Leicester
Zip: LE1 5WW
Country: United Kingdom

Facility:
Name: University College London Hospital NHS Foundation Trust ( Site 1806)

Address:
City: London
Zip: NW1 2BU
Country: United Kingdom

Facility:
Name: Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808)

Address:
City: London
Zip: SE1 9RT
Country: United Kingdom

Facility:
Name: Norfolk and Norwich University Foundation NHS Trust ( Site 1805)

Address:
City: Norwich
Zip: NR47UY
Country: United Kingdom

Facility:
Name: Oxford University Hospitals NHS Foundation Trust ( Site 1812)

Address:
City: Oxford
Zip: OX3 7LE
Country: United Kingdom

Facility:
Name: Darlington Memorial Hospital NHS Trust ( Site 1810)

Address:
City: Darlington
Zip: DLX 6HX
Country: United Kingdom

Facility:
Name: Mount Vernon Hospital ( Site 1803)

Address:
City: Northwood
Zip: HA6 2RN
Country: United Kingdom

Start date: June 25, 2019

Completion date: July 1, 2026

Lead sponsor:
Agency: Merck Sharp & Dohme LLC
Agency class: Industry

Source: Merck Sharp & Dohme LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT03924869
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-867&&kw=3475-867