Back to resultsPembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
Primary Purpose
Carcinoma, Squamous Cell
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab 400 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Squamous Cell focused on measuring Programmed Cell Death-1 (PD-1), Programmed Cell Death 1, PD1, Programmed Cell Death Ligand 1 (PD-L1), Programmed Cell Death Ligand 2 (PD-L2), PDL1, PDL2
Eligibility Criteria
Inclusion Criteria:
- 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 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 woman of childbearing potential (WOCBP)
- 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:
- 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 co-stimulatory or co-inhibitory 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
Sites / Locations
- University of South Alabama, Mitchell Cancer Institute ( Site 1562)Recruiting
- City of Hope Medical Center ( Site 1505)Recruiting
- UCSD Moores Cancer Center ( Site 1561)Recruiting
- UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)Recruiting
- University of California Davis Comprehensive Cancer Center ( Site 1560)Recruiting
- Stanford University Medical Center ( Site 1503)
- University of Colorado Cancer Center ( Site 1506)Recruiting
- Smilow Cancer Center at Yale-New Haven ( Site 1507)Recruiting
- Boca Raton Regional Hospital ( Site 1551)
- UF Health ( Site 1511)Recruiting
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544)Recruiting
- Winship Cancer Institute of Emory University ( Site 1512)
- Indiana University Melvin and Bren Simon Cancer Center ( Site 1515)
- University of Iowa Hospital and Clinics ( Site 1514)Recruiting
- University of Kentucky School of Medicine & Hospitals ( Site 1542)
- Massachusetts General Hospital ( Site 1518)
- Dana Farber Cancer Center ( Site 1519)Recruiting
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 1526)
- Monter Cancer Center-Medical Oncology ( Site 1565)Recruiting
- Icahn School of Medicine at Mount Sinai ( Site 1575)Recruiting
- Cleveland Clinic ( Site 1541)Recruiting
- Providence Portland Medical Center ( Site 1530)Recruiting
- UPMC Hillman Cancer Center ( Site 1570)Recruiting
- MUSC Hollings Cancer Center ( Site 1533)Recruiting
- West Cancer Center - East Campus ( Site 1535)
- Vanderbilt Ingram Cancer Center ( Site 1543)Recruiting
- The University of Texas-MD Anderson Cancer Center ( Site 1536)
- Huntsman Cancer Institute ( Site 1537)Recruiting
- Inova Schar Cancer Institute ( Site 1538)Recruiting
- West Virginia University ( Site 1569)Recruiting
- Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0028)Recruiting
- Centro Medico Privado CEMAIC ( Site 0024)Recruiting
- Fundacion Estudios Clinicos-Oncology ( Site 0026)Recruiting
- Centro Oncológico de Rosario ( Site 0003)Recruiting
- Hospital Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009)Recruiting
- CEMIC ( Site 0012)Recruiting
- Fundacion CIDEA ( Site 0001)Recruiting
- Centro Oncologico Riojano Integral ( Site 0002)Recruiting
- Centro Oncologico Norte ( Site 0023)Recruiting
- Chris OBrien Lifehouse ( Site 0051)Recruiting
- Lismore Base Hospital ( Site 0050)Recruiting
- Orange Health Services ( Site 0053)Recruiting
- Royal North Shore Hospital ( Site 0052)Recruiting
- Gold Coast University Hospital ( Site 0054)Recruiting
- Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 0056)Recruiting
- Alfred Health ( Site 0055)Recruiting
- Oncocentro Ceara ( Site 0108)Recruiting
- Hospital Erasto Gaertner ( Site 0101)
- Hospital Tacchini ( Site 0111)Recruiting
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0100)Recruiting
- Hospital Bruno Born ( Site 0107)Recruiting
- Hospital Sao Vicente de Paulo ( Site 0105)Recruiting
- Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0103)Recruiting
- A. C. Camargo Cancer Center ( Site 0116)Recruiting
- Tom Baker Cancer Center ( Site 0161)Recruiting
- Cross Cancer Institute ( Site 0159)
- Juravinski Cancer Center ( Site 0151)Recruiting
- The Ottawa Hospital Cancer Centre ( Site 0154)Recruiting
- CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0163)Recruiting
- McGill University Health Centre ( Site 0162)Recruiting
- James Lind Centro de Investigación del Cáncer ( Site 1653)Recruiting
- Bradfordhill ( Site 1651)Recruiting
- Centro de Investigación Oncológica del Norte ( Site 1652)Recruiting
- Oncomedica S.A. ( Site 0205)
- Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0201)Recruiting
- Instituto Nacional de Cancerologia E.S.E ( Site 0204)Recruiting
- Oncologos del Occidente S.A. ( Site 0206)Recruiting
- Fundación Cardiovascular de Colombia ( Site 0207)
- Fundacion Valle del Lili ( Site 0202)Recruiting
- Hopital ARCHET 2 ( Site 0356)Recruiting
- Hopital Saint Joseph ( Site 0376)Recruiting
- Hopital La Timone ( Site 0353)Recruiting
- Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0365)Recruiting
- CHU Besancon - Hopital Jean Minjoz ( Site 0359)Recruiting
- Centre Hospitalier de Valence ( Site 0377)Recruiting
- C.H.U. de Nimes. Hopital Caremeau ( Site 0368)Recruiting
- CHU de Bordeaux- Hopital Saint Andre ( Site 0370)Recruiting
- Institut Claudius Regaud IUCT Oncopole ( Site 0354)Recruiting
- Centre Hospitalier Annecy Genevois ( Site 0361)Recruiting
- CHU Montpellier. ( Site 0367)Recruiting
- CHRU de Lille - Hopital Claude Huriez ( Site 0355)Recruiting
- CHU Estaing ( Site 0360)Recruiting
- CH Lyon Sud Hospices Civils de Lyon ( Site 0350)Recruiting
- Hopital Avicenne ( Site 0358)Recruiting
- Institut Gustave Roussy ( Site 0352)Recruiting
- CHU Poitiers ( Site 0375)
- Universitaetsklinikum Tuebingen ( Site 0409)Recruiting
- Klinikum Nürnberg Nord ( Site 0415)Recruiting
- Universitatsklinikum Giessen und Marburg GmbH ( Site 0413)Recruiting
- Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0411)Recruiting
- Medizinische Hochschule Hannover ( Site 0405)
- Universitaetsklinikum Essen ( Site 0403)Recruiting
- Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400)Recruiting
- Universitaetsklinikum Hamburg-Eppendorf ( Site 0414)Recruiting
- Andreas Syggros Hospital ( Site 0450)Recruiting
- Attikon University General Hospital of Athens ( Site 0454)Recruiting
- Metropolitan Hospital ( Site 0453)
- Papageorgiou General Hospital ( Site 0451)
- European Interbalkan Medical Center ( Site 0455)Recruiting
- Pecsi Tudomanyegyetem AOK ( Site 0501)Recruiting
- Szegedi Tudomanyegyetem ( Site 0504)Recruiting
- Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 0500)
- Debreceni Egyetem. ( Site 0506)
- Semmelweis Egyetem ( Site 0507)Recruiting
- Szent Imre Egyetemi Oktatokorhaz ( Site 0502)Recruiting
- St. James s Hospital ( Site 1601)Recruiting
- Soroka University Medical Center ( Site 0555)Recruiting
- Rambam Health Care Campus-Oncology Division ( Site 0552)Recruiting
- Haddassah Medical Organization - Ein Kerem ( Site 0553)Recruiting
- Meir Medical Center ( Site 0556)
- Rabin Medical Center ( Site 0550)Recruiting
- Chaim Sheba Medical Center ( Site 0551)
- Sourasky Medical Center ( Site 0554)
- Instituto Tumori Giovanni Paolo II ( Site 0604)Recruiting
- Azienda Ospedaliero Universitaria Pisana ( Site 0603)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0600)Recruiting
- Istituto Europeo di Oncologia ( Site 0602)Recruiting
- Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601)Recruiting
- San Lucas Cardiologica del Sureste S.A de C.V. ( Site 0722)Recruiting
- Cimab SA de CV ( Site 0708)
- Centro de Investigación Clínica de Alta Especialidad ( Site 0715)
- Onco-Hematologia de Occidente ( Site 0716)Recruiting
- Hospital de Especialidades Centro Medico de Occidente ( Site 0704)
- Consultorios de Medicina Especializada del Sector Privado ( Site 0701)
- Centro de atencion e investigacion clinica en oncologia ( Site 0706)
- Centro Estatal de Cancerologia de Chihuahua ( Site 0703)Recruiting
- FAICIC Clinical Research ( Site 0700)Recruiting
- New Zealand Clinical Research (Auckland) ( Site 0800)Recruiting
- Haukeland sykehus ( Site 0851)Recruiting
- St. Olavs Hospital HF ( Site 0852)
- Oslo Universitetssykehus Radiumhospitalet ( Site 0850)Recruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 0959)Recruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0951)Recruiting
- Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( SiteRecruiting
- Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0958)Recruiting
- Hospital Particular do Algarve ( Site 1005)
- Instituto Portugues de Oncologia de Lisboa ( Site 1003)Recruiting
- Hospital CUF - Tejo ( Site 1004)
- CHLN Hospital Santa Maria ( Site 1001)
- Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1000)Recruiting
- S C Pelican Impex SRL ( Site 1108)
- Hifu Terramed Conformal SRL ( Site 1111)
- Cardiomed SRL Cluj-Napoca ( Site 1104)Recruiting
- Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1113)Recruiting
- Spitalul Universitar CF Cluj-Napoca ( Site 1103)Recruiting
- S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1101)Recruiting
- S C Oncocenter Oncologie Medicala S R L ( Site 1106)Recruiting
- Policlinica Oncomed SRL ( Site 1105)Recruiting
- S.C.Focus Lab Plus S.R.L ( Site 1107)Recruiting
- Spitalul de Psihiatrie Titan Dr. Constantin Gorgos ( Site 1112)
- Altay Regional Oncology Dispensary ( Site 1168)
- GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1171)
- A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological
- Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159)
- Hadassah Medical-Oncology department ( Site 1173)
- N.N. Blokhin NMRCO ( Site 1153)
- FSCC FMBA of Russia ( Site 1163)
- First Moscow State Medical University n.a. I.M.Sechenov ( Site 1164)
- Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169)
- Railway Hospital of OJSC ( Site 1161)
- Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158)
- Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152)
- Hospital Duran i Reynals ( Site 1254)
- Hospital Universitario Marques de Valdecilla ( Site 1256)
- Hospital Clinic i Provincial Barcelona ( Site 1253)Recruiting
- Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1258)Recruiting
- Hospital General Universitari Vall d Hebron ( Site 1252)Recruiting
- Hospital Universitario Ramon y Cajal ( Site 1251)Recruiting
- Hospital Universitario Carlos Haya ( Site 1255)Recruiting
- Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (
- Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1450)
- Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 1451)
- Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 1452)
- Universal Clinic Oberig-Oncology Center ( Site 1461)
- Royal Cornwall Hospitals NHS Trust ( Site 1402)Recruiting
- University College Hospital London ( Site 1400)Recruiting
- Guy s & St Thomas NHS Foundation Trust ( Site 1407)Recruiting
- The Royal Marsden Hospital-Institute of Cancer Research ( Site 1406)Recruiting
- Royal Marsden NHS Foundation Trust ( Site 1408)
- Churchill Hospital ( Site 1404)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pembrolizumab
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy
RFS 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.
Secondary Outcome Measures
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Change from baseline in the score of EORTC QLQ-C30 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, which contains 30 items and measures 5 functioning dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. Scores ranged from 0 -100. For functional and global quality of life (QoL) scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL.
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.
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 will be presented.
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 will be presented.
Full Information
NCT ID
NCT03833167
First Posted
February 4, 2019
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT03833167
Brief Title
Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
Official Title
A 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 Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 5, 2025 (Anticipated)
Study Completion Date
September 29, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell
Keywords
Programmed Cell Death-1 (PD-1), Programmed Cell Death 1, PD1, Programmed Cell Death Ligand 1 (PD-L1), Programmed Cell Death Ligand 2 (PD-L2), PDL1, PDL2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
570 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab 400 mg
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
Administered by IV infusion on Day 1 of each 42-day cycle
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by IV infusion on Day 1 of each 42-day cycle
Primary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy
Description
RFS 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.
Time Frame
Up to approximately 60 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is the time from randomization to death due to any cause.
Time Frame
Up to approximately 60 months
Title
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Description
Change from baseline in the score of EORTC QLQ-C30 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, which contains 30 items and measures 5 functioning dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. Scores ranged from 0 -100. For functional and global quality of life (QoL) scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL.
Time Frame
Baseline and up to approximately 60 months
Title
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
Description
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.
Time Frame
Baseline and up to approximately 60 months
Title
Percentage of Participants Who Experience an Adverse Event (AE)
Description
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 will be presented.
Time Frame
Up to approximately 63 months
Title
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Description
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 will be presented.
Time Frame
Up to approximately 38 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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 woman of childbearing potential (WOCBP)
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:
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 co-stimulatory or co-inhibitory 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama, Mitchell Cancer Institute ( Site 1562)
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
251-665-8000
Facility Name
City of Hope Medical Center ( Site 1505)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
626-218-5822
Facility Name
UCSD Moores Cancer Center ( Site 1561)
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
858-534-3804
Facility Name
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-206-3859
Facility Name
University of California Davis Comprehensive Cancer Center ( Site 1560)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
916-734-3604
Facility Name
Stanford University Medical Center ( Site 1503)
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Completed
Facility Name
University of Colorado Cancer Center ( Site 1506)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
720-848-0676
Facility Name
Smilow Cancer Center at Yale-New Haven ( Site 1507)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
203-737-7981
Facility Name
Boca Raton Regional Hospital ( Site 1551)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Completed
Facility Name
UF Health ( Site 1511)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
352265068087617
Facility Name
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
305-243-2647
Facility Name
Winship Cancer Institute of Emory University ( Site 1512)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Individual Site Status
Completed
Facility Name
Indiana University Melvin and Bren Simon Cancer Center ( Site 1515)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Completed
Facility Name
University of Iowa Hospital and Clinics ( Site 1514)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
319-467-5827
Facility Name
University of Kentucky School of Medicine & Hospitals ( Site 1542)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Completed
Facility Name
Massachusetts General Hospital ( Site 1518)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Completed
Facility Name
Dana Farber Cancer Center ( Site 1519)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-632-6571
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1526)
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Completed
Facility Name
Monter Cancer Center-Medical Oncology ( Site 1565)
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
516-734-8896
Facility Name
Icahn School of Medicine at Mount Sinai ( Site 1575)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
212-659-5600
Facility Name
Cleveland Clinic ( Site 1541)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
216-444-7552
Facility Name
Providence Portland Medical Center ( Site 1530)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
503-215-2614
Facility Name
UPMC Hillman Cancer Center ( Site 1570)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
412-623-7368
Facility Name
MUSC Hollings Cancer Center ( Site 1533)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
843-792-6022
Facility Name
West Cancer Center - East Campus ( Site 1535)
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt Ingram Cancer Center ( Site 1543)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
800-811-8480
Facility Name
The University of Texas-MD Anderson Cancer Center ( Site 1536)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Completed
Facility Name
Huntsman Cancer Institute ( Site 1537)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
801-587-9834
Facility Name
Inova Schar Cancer Institute ( Site 1538)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
703-970-6548
Facility Name
West Virginia University ( Site 1569)
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
304-598-6727
Facility Name
Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0028)
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1027AAP
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5491156455799
Facility Name
Centro Medico Privado CEMAIC ( Site 0024)
City
Capital
State/Province
Cordoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
543514766837
Facility Name
Fundacion Estudios Clinicos-Oncology ( Site 0026)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5493469699922
Facility Name
Centro Oncológico de Rosario ( Site 0003)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KZE
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+543414218909
Facility Name
Hospital Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009)
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541149590200
Facility Name
CEMIC ( Site 0012)
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5491154939856
Facility Name
Fundacion CIDEA ( Site 0001)
City
Caba
ZIP/Postal Code
C1121ABE
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541149615466
Facility Name
Centro Oncologico Riojano Integral ( Site 0002)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+543804468748
Facility Name
Centro Oncologico Norte ( Site 0023)
City
Santiago del Estero
ZIP/Postal Code
G4200AWD
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5491165820007
Facility Name
Chris OBrien Lifehouse ( Site 0051)
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61285140922
Facility Name
Lismore Base Hospital ( Site 0050)
City
Lismore
State/Province
New South Wales
ZIP/Postal Code
2480
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61266294559
Facility Name
Orange Health Services ( Site 0053)
City
Orange
State/Province
New South Wales
ZIP/Postal Code
2800
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+0401958122
Facility Name
Royal North Shore Hospital ( Site 0052)
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61294631181
Facility Name
Gold Coast University Hospital ( Site 0054)
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61756872715
Facility Name
Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 0056)
City
Sunshine Coast
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+617 5390 6057
Facility Name
Alfred Health ( Site 0055)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61 3 9076 2000
Facility Name
Oncocentro Ceara ( Site 0108)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60135-237
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5585988847459
Facility Name
Hospital Erasto Gaertner ( Site 0101)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Completed
Facility Name
Hospital Tacchini ( Site 0111)
City
Bento Goncalves
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95700-084
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5554345543331125
Facility Name
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0100)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+555533319393
Facility Name
Hospital Bruno Born ( Site 0107)
City
Lajeado
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95900-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5551371475002476
Facility Name
Hospital Sao Vicente de Paulo ( Site 0105)
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+555421034130
Facility Name
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0103)
City
Rio de Janeiro
ZIP/Postal Code
20220-410
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+552132072985
Facility Name
A. C. Camargo Cancer Center ( Site 0116)
City
Sao Paulo
ZIP/Postal Code
01509-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+55 11 994270884
Facility Name
Tom Baker Cancer Center ( Site 0161)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4035213093
Facility Name
Cross Cancer Institute ( Site 0159)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Completed
Facility Name
Juravinski Cancer Center ( Site 0151)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
9053879495
Facility Name
The Ottawa Hospital Cancer Centre ( Site 0154)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
613737770070185
Facility Name
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0163)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5142523400 x5766
Facility Name
McGill University Health Centre ( Site 0162)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
514-934-1934
Facility Name
James Lind Centro de Investigación del Cáncer ( Site 1653)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56994443272
Facility Name
Bradfordhill ( Site 1651)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56998744662
Facility Name
Centro de Investigación Oncológica del Norte ( Site 1652)
City
Antofagasta
ZIP/Postal Code
1240000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56994198125
Facility Name
Oncomedica S.A. ( Site 0205)
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230002
Country
Colombia
Individual Site Status
Completed
Facility Name
Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0201)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111411
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+573002037459
Facility Name
Instituto Nacional de Cancerologia E.S.E ( Site 0204)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111511
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+573108658288
Facility Name
Oncologos del Occidente S.A. ( Site 0206)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
661002
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+573114746650
Facility Name
Fundación Cardiovascular de Colombia ( Site 0207)
City
Piedecuesta
State/Province
Santander
ZIP/Postal Code
68017
Country
Colombia
Individual Site Status
Completed
Facility Name
Fundacion Valle del Lili ( Site 0202)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+573148883972
Facility Name
Hopital ARCHET 2 ( Site 0356)
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33492036223
Facility Name
Hopital Saint Joseph ( Site 0376)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13285
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33491806625
Facility Name
Hopital La Timone ( Site 0353)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33491387991
Facility Name
Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0365)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33231272506
Facility Name
CHU Besancon - Hopital Jean Minjoz ( Site 0359)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33381218102
Facility Name
Centre Hospitalier de Valence ( Site 0377)
City
Valence
State/Province
Drome
ZIP/Postal Code
26953
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33475757549
Facility Name
C.H.U. de Nimes. Hopital Caremeau ( Site 0368)
City
Nimes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33466684043
Facility Name
CHU de Bordeaux- Hopital Saint Andre ( Site 0370)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33075
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33557822521
Facility Name
Institut Claudius Regaud IUCT Oncopole ( Site 0354)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33567778134
Facility Name
Centre Hospitalier Annecy Genevois ( Site 0361)
City
Pringy
State/Province
Haute-Savoie
ZIP/Postal Code
74374
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33450636863
Facility Name
CHU Montpellier. ( Site 0367)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33467336933
Facility Name
CHRU de Lille - Hopital Claude Huriez ( Site 0355)
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33320444193
Facility Name
CHU Estaing ( Site 0360)
City
Clermont-Ferrand
State/Province
Puy-de-Dome
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33473755226
Facility Name
CH Lyon Sud Hospices Civils de Lyon ( Site 0350)
City
Pierre Benite
State/Province
Rhone
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33478861679
Facility Name
Hopital Avicenne ( Site 0358)
City
Bobigny
State/Province
Seine-Saint-Denis
ZIP/Postal Code
93009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33148957090
Facility Name
Institut Gustave Roussy ( Site 0352)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33142114210
Facility Name
CHU Poitiers ( Site 0375)
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Individual Site Status
Completed
Facility Name
Universitaetsklinikum Tuebingen ( Site 0409)
City
Tuebingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4970712985748
Facility Name
Klinikum Nürnberg Nord ( Site 0415)
City
Nürnberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49 911 398 2044
Facility Name
Universitatsklinikum Giessen und Marburg GmbH ( Site 0413)
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4964215862321
Facility Name
Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0411)
City
Buxtehude
State/Province
Niedersachsen
ZIP/Postal Code
21614
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4941617036250
Facility Name
Medizinische Hochschule Hannover ( Site 0405)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Completed
Facility Name
Universitaetsklinikum Essen ( Site 0403)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+492017232431
Facility Name
Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4930450518705
Facility Name
Universitaetsklinikum Hamburg-Eppendorf ( Site 0414)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
004915222873742
Facility Name
Andreas Syggros Hospital ( Site 0450)
City
Athens
State/Province
Achaia
ZIP/Postal Code
161 21
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302107265212
Facility Name
Attikon University General Hospital of Athens ( Site 0454)
City
Chaidari
State/Province
Attiki
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+306944888568
Facility Name
Metropolitan Hospital ( Site 0453)
City
Neo Faliro
State/Province
Attiki
ZIP/Postal Code
185 47
Country
Greece
Individual Site Status
Completed
Facility Name
Papageorgiou General Hospital ( Site 0451)
City
Thessaloniki
ZIP/Postal Code
564 03
Country
Greece
Individual Site Status
Completed
Facility Name
European Interbalkan Medical Center ( Site 0455)
City
Thessaloniki
ZIP/Postal Code
570 01
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+306942608228
Facility Name
Pecsi Tudomanyegyetem AOK ( Site 0501)
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7632
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36202520267
Facility Name
Szegedi Tudomanyegyetem ( Site 0504)
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3662545545
Facility Name
Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 0500)
City
Nyiregyhaza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Completed
Facility Name
Debreceni Egyetem. ( Site 0506)
City
Debrecen
State/Province
Vas
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Completed
Facility Name
Semmelweis Egyetem ( Site 0507)
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36206663413
Facility Name
Szent Imre Egyetemi Oktatokorhaz ( Site 0502)
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36209434922
Facility Name
St. James s Hospital ( Site 1601)
City
Dublin 8
State/Province
Dublin
ZIP/Postal Code
D08 K0Y5
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3514162164
Facility Name
Soroka University Medical Center ( Site 0555)
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97286400295
Facility Name
Rambam Health Care Campus-Oncology Division ( Site 0552)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+9724854311
Facility Name
Haddassah Medical Organization - Ein Kerem ( Site 0553)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972508946244
Facility Name
Meir Medical Center ( Site 0556)
City
Kfar-Saba
ZIP/Postal Code
4428132
Country
Israel
Individual Site Status
Completed
Facility Name
Rabin Medical Center ( Site 0550)
City
Petah Tiqwa
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97239378004
Facility Name
Chaim Sheba Medical Center ( Site 0551)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Completed
Facility Name
Sourasky Medical Center ( Site 0554)
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Completed
Facility Name
Instituto Tumori Giovanni Paolo II ( Site 0604)
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390805555363
Facility Name
Azienda Ospedaliero Universitaria Pisana ( Site 0603)
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39050992466
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0600)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390223902150
Facility Name
Istituto Europeo di Oncologia ( Site 0602)
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3902574891094
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390815903752
Facility Name
San Lucas Cardiologica del Sureste S.A de C.V. ( Site 0722)
City
Tuxtla Gutierrez
State/Province
Chiapas
ZIP/Postal Code
29090
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5215543785105
Facility Name
Cimab SA de CV ( Site 0708)
City
Torreon
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
Individual Site Status
Completed
Facility Name
Centro de Investigación Clínica de Alta Especialidad ( Site 0715)
City
Torreón
State/Province
Coahuila
ZIP/Postal Code
27010
Country
Mexico
Individual Site Status
Completed
Facility Name
Onco-Hematologia de Occidente ( Site 0716)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44260
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3315145351
Facility Name
Hospital de Especialidades Centro Medico de Occidente ( Site 0704)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44349
Country
Mexico
Individual Site Status
Completed
Facility Name
Consultorios de Medicina Especializada del Sector Privado ( Site 0701)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44680
Country
Mexico
Individual Site Status
Completed
Facility Name
Centro de atencion e investigacion clinica en oncologia ( Site 0706)
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97134
Country
Mexico
Individual Site Status
Completed
Facility Name
Centro Estatal de Cancerologia de Chihuahua ( Site 0703)
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+526144106742
Facility Name
FAICIC Clinical Research ( Site 0700)
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+522299327808
Facility Name
New Zealand Clinical Research (Auckland) ( Site 0800)
City
Auckland
ZIP/Postal Code
0624
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6493733474
Facility Name
Haukeland sykehus ( Site 0851)
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4755974200
Facility Name
St. Olavs Hospital HF ( Site 0852)
City
Trondheim
State/Province
Sor-Trondelag
ZIP/Postal Code
7030
Country
Norway
Individual Site Status
Completed
Facility Name
Oslo Universitetssykehus Radiumhospitalet ( Site 0850)
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4722934000
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 0959)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-115
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48607941715
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0951)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48226439375
Facility Name
Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48583493190
Facility Name
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0958)
City
Gliwice
State/Province
Slaskie
ZIP/Postal Code
44101
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48784981888
Facility Name
Hospital Particular do Algarve ( Site 1005)
City
Faro
ZIP/Postal Code
8005-226
Country
Portugal
Individual Site Status
Completed
Facility Name
Instituto Portugues de Oncologia de Lisboa ( Site 1003)
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351217805000
Facility Name
Hospital CUF - Tejo ( Site 1004)
City
Lisboa
ZIP/Postal Code
1350-352
Country
Portugal
Individual Site Status
Completed
Facility Name
CHLN Hospital Santa Maria ( Site 1001)
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Completed
Facility Name
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1000)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351225084000
Facility Name
S C Pelican Impex SRL ( Site 1108)
City
Oradea
State/Province
Bihor
ZIP/Postal Code
410469
Country
Romania
Individual Site Status
Completed
Facility Name
Hifu Terramed Conformal SRL ( Site 1111)
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
031864
Country
Romania
Individual Site Status
Completed
Facility Name
Cardiomed SRL Cluj-Napoca ( Site 1104)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40724543672
Facility Name
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1113)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4026459831
Facility Name
Spitalul Universitar CF Cluj-Napoca ( Site 1103)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40724283983
Facility Name
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1101)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200347
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40727774974
Facility Name
S C Oncocenter Oncologie Medicala S R L ( Site 1106)
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300166
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40356464000
Facility Name
Policlinica Oncomed SRL ( Site 1105)
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40745100495
Facility Name
S.C.Focus Lab Plus S.R.L ( Site 1107)
City
Bucuresti
ZIP/Postal Code
022548
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40721298677
Facility Name
Spitalul de Psihiatrie Titan Dr. Constantin Gorgos ( Site 1112)
City
Bucuresti
ZIP/Postal Code
030447
Country
Romania
Individual Site Status
Completed
Facility Name
Altay Regional Oncology Dispensary ( Site 1168)
City
WBarnaularsaw
State/Province
Altayskiy Kray
ZIP/Postal Code
656045
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1171)
City
Ufa
State/Province
Baskortostan, Respublika
ZIP/Postal Code
450054
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological
City
Obninsk
State/Province
Kaluzskaja Oblast
ZIP/Postal Code
249036
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159)
City
Sochi
State/Province
Krasnodarskiy Kray
ZIP/Postal Code
354057
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Hadassah Medical-Oncology department ( Site 1173)
City
Moscow
State/Province
Moskovskaya Oblast
ZIP/Postal Code
121205
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
N.N. Blokhin NMRCO ( Site 1153)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Completed
Facility Name
FSCC FMBA of Russia ( Site 1163)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115682
Country
Russian Federation
Individual Site Status
Completed
Facility Name
First Moscow State Medical University n.a. I.M.Sechenov ( Site 1164)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169)
City
Nizhny Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603126
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Railway Hospital of OJSC ( Site 1161)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
195271
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158)
City
Izhevsk
State/Province
Udmurtskaya Respublika
ZIP/Postal Code
426009
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152)
City
Yaroslavl
State/Province
Yaroslavskaya Oblast
ZIP/Postal Code
150054
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Hospital Duran i Reynals ( Site 1254)
City
Hospitalet del Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Marques de Valdecilla ( Site 1256)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Clinic i Provincial Barcelona ( Site 1253)
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932275402
Facility Name
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1258)
City
Doniostia - San Sebastian
State/Province
Gipuzkoa
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34943328315
Facility Name
Hospital General Universitari Vall d Hebron ( Site 1252)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+349327460004350
Facility Name
Hospital Universitario Ramon y Cajal ( Site 1251)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34913368263
Facility Name
Hospital Universitario Carlos Haya ( Site 1255)
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34951291165
Facility Name
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76018
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1450)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61103
Country
Ukraine
Individual Site Status
Completed
Facility Name
Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 1451)
City
Kropyvnytskyi
State/Province
Kirovohradska Oblast
ZIP/Postal Code
25011
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 1452)
City
Sumy
State/Province
Sumska Oblast
ZIP/Postal Code
40022
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Universal Clinic Oberig-Oncology Center ( Site 1461)
City
Kyiv
ZIP/Postal Code
03057
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Royal Cornwall Hospitals NHS Trust ( Site 1402)
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441872258310
Facility Name
University College Hospital London ( Site 1400)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4402034475085
Facility Name
Guy s & St Thomas NHS Foundation Trust ( Site 1407)
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4402071887188
Facility Name
The Royal Marsden Hospital-Institute of Cancer Research ( Site 1406)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442078082132
Facility Name
Royal Marsden NHS Foundation Trust ( Site 1408)
City
Sutton
State/Province
London, City Of
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Churchill Hospital ( Site 1404)
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Completed
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trial Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-630&kw=3475-630
Description
Plain Language Summary
Learn more about this trial
Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
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