Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified January 2026 by Merck Sharp & Dohme LLC
Sponsor
Merck Sharp & Dohme LLC
Information Provided by (Responsible Party)
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
NCT03833167
Other Study ID Numbers:
3475-630
First Submitted
February 3, 2019
First Posted
February 5, 2019
Results First Posted
June 16, 2025
Last Update Posted
March 9, 2026
Last Verified
January 2026

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

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Carcinoma, Squamous Cell
Biological: PembrolizumabDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment450 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)
Study Start DateMarch 31, 2019
Actual Primary Completion DateJune 27, 2024
Actual Study Completion DateJanuary 19, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
Pembrolizumab
Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.
Biological: Pembrolizumab
400 mg IV infusion
Placebo
Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.
Drug: Placebo
Placebo-matched IV infusion

Outcome Measures

Primary Outcome Measures
  1. Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy
    RFS as assessed by investigator was defined as the time between the date of randomization to the date of first local or regional recurrence of the index lesion, distant metastasis, or death due to any cause; whichever occurred first. Participants were analyzed in the treatment group to which they were randomized. RFS as assessed by investigator is presented.
Secondary Outcome Measures
  1. Overall Survival (OS)
    OS is the time from randomization to death due to any cause. Participants were analyzed in the treatment group to which they were randomized. OS is presented.
  2. Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score is presented.
  3. Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score
    Change from baseline in the score of EORTC QLQ-C30 Items 1-5 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores meant a better level of function. Participants were analyzed in the treatment group to which they were randomized. Change from baseline in EORTC QLQ-C30 physical functioning is presented.
  4. Percentage of Participants Who Experience an Adverse Event (AE)
    An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who experience at least one AE is presented.
  5. Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
    An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who discontinue study treatment due to an AE is presented.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion Criteria include, but are not limited to:
Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another type of primary cancer or from an unknown primary cancer is not permitted)
Has histologically confirmed locally advanced cutaneous squamous cell carcinoma (LA cSCC) with ≥1 high-risk feature(s) as the primary site of malignancy
Has undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins. For those participants with residual microscopic positive margin involvement, confirmation that additional re-excision is not possible must be provided
Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization
Has received an adequate post-op dose of RT (either hypofractionated or conventional)
Is disease free as assessed by the investigator with complete radiographic staging assessment ≤28 days from randomization
Is not pregnant or breastfeeding
Is not a person of childbearing potential (POCBP)
Has a negative pregnancy test ≤72 hours before the first dose of study intervention.
Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing
Has a life expectancy of \>3 months
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ≤10 days prior to the first dose of study intervention.
Exclusion Criteria
Exclusion criteria include, but are not limited to:
Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease before randomization
Has any other histologic type of skin cancer other than invasive cSCC (eg, basal cell carcinoma) that has not been definitively treated with surgery or radiation; Bowen's disease; Merkel cell carcinoma; or melanoma
Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti-PD-L1, or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another costimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
Has received prior systemic anticancer therapy including investigational agents for cSCC ≤4 weeks prior to before start of study intervention.
Has not recovered from all radiation-related toxicities and has not had radiation pneumonitis
Has received a live vaccine ≤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 treatment.
Has known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Other exceptions may be considered with Sponsor consultation. Note: Participants with low risk early-stage prostate cancer defined as below are not excluded: Stage T1c or T2a with a Gleason score ≤6 and a prostate-specific antigen (≤10 ng/ml) either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation. Early stage asymptomatic CLL without prior treatment and without any of the risk features (unmutated IGHV, lymphocytes \>15,000μL, palpable lymph nodes) will be eligible for the study
Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid).
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (HCV; defined as HCV RNA \[qualitative\] is detected) infection
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 study intervention
Has had an allogeneic tissue/solid organ transplant

Contacts and Locations

Sponsors and CollaboratorsMerck Sharp & Dohme LLC
Locations
University of South Alabama, Mitchell Cancer Institute ( Site 1562) | Mobile Alabama, United States, 36604City of Hope Medical Center ( Site 1505) | Duarte California, United States, 91010UCSD Moores Cancer Center ( Site 1561) | La Jolla California, United States, 92093-0698UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568) | Los Angeles California, United States, 90095University of California Davis Comprehensive Cancer Center ( Site 1560) | Sacramento California, United States, 95817Stanford University Medical Center ( Site 1503) | Stanford California, United States, 94305University of Colorado Cancer Center ( Site 1506) | Aurora Colorado, United States, 80045Smilow Cancer Center at Yale-New Haven ( Site 1507) | New Haven Connecticut, United States, 06510Boca Raton Regional Hospital ( Site 1551) | Boca Raton Florida, United States, 33486UF Health ( Site 1511) | Gainesville Florida, United States, 32608University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544) | Miami Florida, United States, 33136Winship Cancer Institute of Emory University ( Site 1512) | Atlanta Georgia, United States, 30322-1013Indiana University Melvin and Bren Simon Cancer Center ( Site 1515) | Indianapolis Indiana, United States, 46202University of Iowa Hospital and Clinics ( Site 1514) | Iowa City Iowa, United States, 52242University of Kentucky School of Medicine & Hospitals ( Site 1542) | Lexington Kentucky, United States, 40536Massachusetts General Hospital ( Site 1518) | Boston Massachusetts, United States, 02114Dana Farber Cancer Center ( Site 1519) | Boston Massachusetts, United States, 02215John Theurer Cancer Center at Hackensack University Medical Center ( Site 1526) | Hackensack New Jersey, United States, 07601Northwell Health/ RJ Zuckerberg Cancer Center-Medical Oncology ( Site 1565) | Lake Success New York, United States, 11042Icahn School of Medicine at Mount Sinai ( Site 1575) | New York New York, United States, 10029Cleveland Clinic ( Site 1541) | Cleveland Ohio, United States, 44195Providence Portland Medical Center ( Site 1530) | Portland Oregon, United States, 97213UPMC Hillman Cancer Center ( Site 1570) | Pittsburgh Pennsylvania, United States, 15232MUSC Hollings Cancer Center ( Site 1533) | Charleston South Carolina, United States, 29425West Cancer Center - East Campus ( Site 1535) | Germantown Tennessee, United States, 38138Vanderbilt Ingram Cancer Center ( Site 1543) | Nashville Tennessee, United States, 37232The University of Texas-MD Anderson Cancer Center ( Site 1536) | Houston Texas, United States, 77030Huntsman Cancer Institute ( Site 1537) | Salt Lake City Utah, United States, 84112Inova Schar Cancer Institute ( Site 1538) | Fairfax Virginia, United States, 22031West Virginia University ( Site 1569) | Morgantown West Virginia, United States, 26506Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0028) | Ciudad Autónoma de Buenos Aires Buenos Aires, Argentina, C1027AAPCentro Medico Privado CEMAIC ( Site 0024) | Capital Córdoba Province, Argentina, X5008HHWFundacion Estudios Clinicos-Oncology ( Site 0026) | Rosario Santa Fe Province, Argentina, S2000DEJCentro Oncológico de Rosario ( Site 0003) | Rosario Santa Fe Province, Argentina, S2000KZEHospital Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009) | Buenos Aires , Argentina, C1181ACHCEMIC ( Site 0012) | Buenos Aires , Argentina, C1431FWOFundacion CIDEA ( Site 0001) | CABA , Argentina, C1121ABECentro Oncologico Riojano Integral ( Site 0002) | La Rioja , Argentina, F5300COECentro Oncologico Norte ( Site 0023) | Santiago del Estero , Argentina, G4200AWDChris OBrien Lifehouse ( Site 0051) | Camperdown New South Wales, Australia, 2050Lismore Base Hospital ( Site 0050) | Lismore New South Wales, Australia, 2480Orange Health Services ( Site 0053) | Orange New South Wales, Australia, 2800Royal North Shore Hospital ( Site 0052) | St Leonards New South Wales, Australia, 2065Gold Coast University Hospital ( Site 0054) | Southport Queensland, Australia, 4215Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 0056) | Sunshine Coast Queensland, Australia, 4575Alfred Health ( Site 0055) | Melbourne Victoria, Australia, 3004Oncocentro Ceara ( Site 0108) | Fortaleza Ceará, Brazil, 60135-237Hospital Erasto Gaertner ( Site 0101) | Curitiba Paraná, Brazil, 81520-060Hospital Tacchini ( Site 0111) | Bento Gonçalves Rio Grande do Sul, Brazil, 95700-084ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0100) | Ijuí Rio Grande do Sul, Brazil, 98700000Hospital Bruno Born ( Site 0107) | Lajeado Rio Grande do Sul, Brazil, 95900-000Hospital Sao Vicente de Paulo ( Site 0105) | Passo Fundo Rio Grande do Sul, Brazil, 99010-080Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0103) | Rio de Janeiro , Brazil, 20220-410A. C. Camargo Cancer Center ( Site 0116) | São Paulo , Brazil, 01509-010Tom Baker Cancer Center ( Site 0161) | Calgary Alberta, Canada, T2N 4N2Cross Cancer Institute ( Site 0159) | Edmonton Alberta, Canada, T6G 1Z2Juravinski Cancer Center ( Site 0151) | Hamilton Ontario, Canada, L8V 1C3The Ottawa Hospital Cancer Centre ( Site 0154) | Ottawa Ontario, Canada, K1H 8L6CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0163) | Montreal Quebec, Canada, H1T 2M4McGill University Health Centre ( Site 0162) | Montreal Quebec, Canada, H4A 3J1James Lind Centro de Investigación del Cáncer ( Site 1653) | Temuco Araucania, Chile, 4800827Enroll SpA ( Site 1654) | Santiago Region M. de Santiago, Chile, 7500587Bradfordhill ( Site 1651) | Santiago Region M. de Santiago, Chile, 8420383Bradford Hill Norte ( Site 1652) | Antofagasta , Chile, 1240000Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0201) | Bogotá Bogota D.C., Colombia, 111411Instituto Nacional de Cancerologia E.S.E ( Site 0204) | Bogotá Bogota D.C., Colombia, 111511Oncomedica S.A. ( Site 0205) | Montería Departamento de Córdoba, Colombia, 230002Oncologos del Occidente S.A. ( Site 0206) | Pereira Risaralda Department, Colombia, 660001Fundación Cardiovascular de Colombia ( Site 0207) | Piedecuesta Santander Department, Colombia, 68017Fundación Valle del Lili ( Site 0202) | Cali Valle del Cauca Department, Colombia, 760032Hopital ARCHET 2 ( Site 0356) | Nice Alpes-Maritimes, France, 06200Hopital Saint Joseph ( Site 0376) | Marseille Bouches-du-Rhone, France, 13285Hopital La Timone ( Site 0353) | Marseille Bouches-du-Rhone, France, 13385Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0365) | Caen Calvados, France, 14000CHU Besancon - Hopital Jean Minjoz ( Site 0359) | Besançon Doubs, France, 25030Centre Hospitalier de Valence ( Site 0377) | Valence Drome, France, 26953C.H.U. de Nimes. Hopital Caremeau ( Site 0368) | Nîmes Gard, France, 30029CHU de Bordeaux- Hopital Saint Andre ( Site 0370) | Bordeaux Gironde, France, 33075Institut Claudius Regaud IUCT Oncopole ( Site 0354) | Toulouse Haute-Garonne, France, 31059Centre Hospitalier Annecy Genevois ( Site 0361) | Pringy Haute-Savoie, France, 74374CHU Montpellier. ( Site 0367) | Montpellier Herault, France, 34295CHRU de Lille - Hopital Claude Huriez ( Site 0355) | Lille Nord, France, 59037CHU Estaing ( Site 0360) | Clermont-Ferrand Puy-de-Dome, France, 63003CH Lyon Sud Hospices Civils de Lyon ( Site 0350) | Pierre-Bénite Rhone, France, 69495Hopital Avicenne ( Site 0358) | Bobigny Seine-Saint-Denis, France, 93009Institut Gustave Roussy ( Site 0352) | Villejuif Val-de-Marne, France, 94800CHU Poitiers ( Site 0375) | Poitiers Vienne, France, 86021Universitaetsklinikum Tuebingen ( Site 0409) | Tübingen Baden-Wurttemberg, Germany, 72076Klinikum Nürnberg Nord ( Site 0415) | Nuremberg Bavaria, Germany, 90419Universitatsklinikum Giessen und Marburg GmbH ( Site 0413) | Marburg Hesse, Germany, 35043Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0411) | Buxtehude Lower Saxony, Germany, 21614Medizinische Hochschule Hannover ( Site 0405) | Hanover Lower Saxony, Germany, 30625Universitaetsklinikum Essen ( Site 0403) | Essen North Rhine-Westphalia, Germany, 45147Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400) | Berlin , Germany, 10117Universitaetsklinikum Hamburg-Eppendorf ( Site 0414) | Hamburg , Germany, 20246Andreas Syggros Hospital ( Site 0450) | Athens Achaia, Greece, 161 21Attikon University General Hospital of Athens ( Site 0454) | Chaïdári Attica, Greece, 124 62Metropolitan Hospital ( Site 0453) | Neo Faliro Attica, Greece, 185 47Papageorgiou General Hospital ( Site 0451) | Thessaloniki , Greece, 564 03European Interbalkan Medical Center ( Site 0455) | Thessaloniki , Greece, 570 01Pecsi Tudomanyegyetem AOK ( Site 0501) | Pécs Baranya, Hungary, 7632Szegedi Tudomanyegyetem ( Site 0504) | Szeged Csongrád megye, Hungary, 6720Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 0500) | Nyíregyháza Szabolcs-Szatmár-Bereg, Hungary, 4400Debreceni Egyetem. ( Site 0506) | Debrecen Vas County, Hungary, 4032Semmelweis Egyetem ( Site 0507) | Budapest , Hungary, 1083Szent Imre Egyetemi Oktatokorhaz ( Site 0502) | Budapest , Hungary, 1115St. James s Hospital ( Site 1601) | Dublin Dublin, Ireland, D08 K0Y5Soroka University Medical Center ( Site 0555) | Beersheba , Israel, 8410101Rambam Health Care Campus-Oncology Division ( Site 0552) | Haifa , Israel, 3109601Haddassah Medical Organization - Ein Kerem ( Site 0553) | Jerusalem , Israel, 9112001Meir Medical Center ( Site 0556) | Kfar Saba , Israel, 4428132Rabin Medical Center ( Site 0550) | Petah Tikva , Israel, 4941492Chaim Sheba Medical Center ( Site 0551) | Ramat Gan , Israel, 5265601Sourasky Medical Center ( Site 0554) | Tel Aviv , Israel, 6423906Instituto Tumori Giovanni Paolo II ( Site 0604) | Bari Apulia, Italy, 70124Azienda Ospedaliero Universitaria Pisana ( Site 0603) | Pisa Tuscany, Italy, 56126Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0600) | Milan , Italy, 20133Istituto Europeo di Oncologia ( Site 0602) | Milan , Italy, 20141Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601) | Naples , Italy, 80131San Lucas Cardiologica del Sureste S.A de C.V. ( Site 0722) | Tuxtla Gutiérrez Chiapas, Mexico, 29090Cimab SA de CV ( Site 0708) | Torreón Coahuila, Mexico, 27000Centro de Investigación Clínica de Alta Especialidad ( Site 0715) | Torreón Coahuila, Mexico, 27010Onco-Hematologia de Occidente ( Site 0716) | Guadalajara Jalisco, Mexico, 44260Hospital de Especialidades Centro Medico de Occidente ( Site 0704) | Guadalajara Jalisco, Mexico, 44349Consultorios de Medicina Especializada del Sector Privado ( Site 0701) | Guadalajara Jalisco, Mexico, 44680Centro de atencion e investigacion clinica en oncologia ( Site 0706) | Mérida Yucatán, Mexico, 97134Centro Estatal de Cancerologia de Chihuahua ( Site 0703) | Chihuahua City , Mexico, 31000FAICIC Clinical Research ( Site 0700) | Veracruz , Mexico, 91900New Zealand Clinical Research (Auckland) ( Site 0800) | Auckland , New Zealand, 0624Haukeland sykehus ( Site 0851) | Bergen Hordaland, Norway, 5021St. Olavs Hospital HF ( Site 0852) | Trondheim Sor-Trondelag, Norway, 7030Oslo Universitetssykehus Radiumhospitalet ( Site 0850) | Oslo , Norway, 0379Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 0959) | Krakow Lesser Poland Voivodeship, Poland, 31-115Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0951) | Warsaw Masovian Voivodeship, Poland, 02-781Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site | Gdansk Pomeranian Voivodeship, Poland, 80-214Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0958) | Gliwice Silesian Voivodeship, Poland, 44-101Hospital Particular do Algarve ( Site 1005) | Faro , Portugal, 8005-226Instituto Portugues de Oncologia de Lisboa ( Site 1003) | Lisbon , Portugal, 1099-023Hospital CUF - Tejo ( Site 1004) | Lisbon , Portugal, 1350-352CHLN Hospital Santa Maria ( Site 1001) | Lisbon , Portugal, 1649-035Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1000) | Porto , Portugal, 4200-072S C Pelican Impex SRL ( Site 1108) | Oradea Bihor County, Romania, 410469Hifu Terramed Conformal SRL ( Site 1111) | Bucharest Bucharest, Romania, 031864Cardiomed SRL Cluj-Napoca ( Site 1104) | Cluj-Napoca Cluj, Romania, 400015Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1113) | Cluj-Napoca Cluj, Romania, 400015Spitalul Universitar CF Cluj-Napoca ( Site 1103) | Cluj-Napoca Cluj, Romania, 400015S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1101) | Craiova Dolj, Romania, 200347S C Oncocenter Oncologie Medicala S R L ( Site 1106) | Timișoara Timiș County, Romania, 300166Policlinica Oncomed SRL ( Site 1105) | Timișoara Timiș County, Romania, 300239S.C.Focus Lab Plus S.R.L ( Site 1107) | Bucharest , Romania, 022548Spitalul de Psihiatrie Titan Dr. Constantin Gorgos ( Site 1112) | Bucharest , Romania, 030447Altay Regional Oncology Dispensary ( Site 1168) | WBarnaularsaw Altayskiy Kray, Russia, 656045GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1171) | Ufa Baskortostan, Respublika, Russia, 450054A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological | Obninsk Kaluzskaja Oblast, Russia, 249036Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159) | Sochi Krasnodarskiy Kray, Russia, 354057N.N. Blokhin NMRCO ( Site 1153) | Moscow Moscow, Russia, 115478FSCC FMBA of Russia ( Site 1163) | Moscow Moscow, Russia, 115682First Moscow State Medical University n.a. I.M.Sechenov ( Site 1164) | Moscow Moscow, Russia, 119991Hadassah Medical-Oncology department ( Site 1173) | Moscow Moscow Oblast, Russia, 121205Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169) | Nizhny Novgorod Nizhny Novgorod Oblast, Russia, 603126Railway Hospital of OJSC ( Site 1161) | Saint Petersburg Sankt-Peterburg, Russia, 195271Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158) | Izhevsk Udmurtiya Republic, Russia, 426009Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152) | Yaroslavl Yaroslavl Oblast, Russia, 150054Hospital Duran i Reynals ( Site 1254) | Hospitalet Del Llobregat Barcelona, Spain, 08908Hospital Universitario Marques de Valdecilla ( Site 1256) | Santander Cantabria, Spain, 39008Hospital Clinic i Provincial Barcelona ( Site 1253) | Barcelona Catalonia, Spain, 08036Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1258) | Doniostia - San Sebastian Gipuzkoa, Spain, 20014Hospital General Universitari Vall d Hebron ( Site 1252) | Barcelona , Spain, 08035Hospital Universitario Ramon y Cajal ( Site 1251) | Madrid , Spain, 28034Hospital Universitario Carlos Haya ( Site 1255) | Málaga , Spain, 29010Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient ( | Ivano-Frankivsk Ivano-Frankivsk Oblast, Ukraine, 76018Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1450) | Kharkiv Kharkivs’ka Oblast’, Ukraine, 61103Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 1451) | Kropyvnytskyi Kirovohrad Oblast, Ukraine, 25011Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 1452) | Sumy Sumska Oblast, Ukraine, 40022Universal Clinic Oberig-Oncology Center ( Site 1461) | Kyiv , Ukraine, 03057Royal Cornwall Hospitals NHS Trust ( Site 1402) | Truro Cornwall, United Kingdom, TR1 3LQUniversity College Hospital London ( Site 1400) | London London, City of, United Kingdom, NW1 2PGGuy s & St Thomas NHS Foundation Trust ( Site 1407) | London London, City of, United Kingdom, SE1 9RTThe Royal Marsden Hospital-Institute of Cancer Research ( Site 1406) | London London, City of, United Kingdom, SW3 6JJRoyal Marsden NHS Foundation Trust ( Site 1408) | Sutton London, City of, United Kingdom, SM2 5PTChurchill Hospital ( Site 1404) | Oxford Oxfordshire, United Kingdom, OX3 7LE
Investigators
Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full Text)
Documents provided by Merck Sharp & Dohme LLC: Study Protocol and Statistical Analysis Plan  December 11, 2024