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Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

Primary Purpose

Cutaneous Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cemiplimab
Placebo
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Squamous Cell Carcinoma focused on measuring High risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • For Japan only, men and women ≥21 years old
  • Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease
  • High risk CSCC, as defined in the protocol
  • Completion of curative intent post-operative radiation therapy (RT) within 2 to 10 weeks of randomization
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1
  • Adequate hepatic, renal, and bone marrow function as defined in the protocol

Key Exclusion Criteria:

  • Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
  • Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol
  • Patients with hematologic malignancies (note: patients with chronic lymphocytic leukemia (CLL) are not excluded if they have not required systemic therapy for CLL within 6 months of enrollment)
  • Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary)
  • Ongoing or recent (within 5 years of randomization date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
  • Has had prior systemic anti-cancer immunotherapy for CSCC

Note: Other protocol defined Inclusion/Exclusion criteria apply

Sites / Locations

  • Banner MD Anderson Cancer CenterRecruiting
  • Mayo Clinic HospitalRecruiting
  • Regeneron Study Site
  • The Angeles Clinic
  • University of Southern California (USC)Recruiting
  • University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
  • George Washington University School of Medicine and Health SciencesRecruiting
  • University of Florida Health
  • Sylvester Comprehensive Cancer Center
  • Miami Cancer Institute at Baptist Health, Inc.Recruiting
  • University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research InstituteRecruiting
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Massachusetts General Cancer CenterRecruiting
  • Dana Farber/Harvard Cancer CenterRecruiting
  • Michigan Medicine- University of MichiganRecruiting
  • University of Missouri Health Care - University Physicians - Medicine Specialty ClinicRecruiting
  • Washington University in Saint LouisRecruiting
  • Nebraska Methodist HospitalRecruiting
  • Memorial Sloan Kettering
  • Memorial Sloan Kettering
  • Memorial Sloan Kettering
  • Memorial Sloan Kettering
  • Memorial Sloan Kettering
  • Memorial Sloan Kettering
  • NYU Langone Health
  • Columbia UniversityRecruiting
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering
  • Regeneron Research Site
  • The Ohio State UniversityRecruiting
  • Penn State Hershey Children's HospitalRecruiting
  • University of PennsylvaniaRecruiting
  • Sarah Cannon Research Institute - Tennessee OncologyRecruiting
  • Texas Oncology - Baylor Charles A. Simmons Cancer Center
  • UT Southwestern Medical CenterRecruiting
  • University Of Virginia Health SystemRecruiting
  • The Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer CentreRecruiting
  • Coffs Harbour Health Campus
  • Central Coast Cancer Centre-Gosford and Wyong HospitalsRecruiting
  • St George HospitalRecruiting
  • North Shore Private HospitalRecruiting
  • Cancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC)Recruiting
  • Calvary Mater NewcastleRecruiting
  • Westmead HospitalRecruiting
  • Illawarra Cancer Care Centre (ICCC)Recruiting
  • Wide Bay Hospital and Health Service - Cancer Care ServicesRecruiting
  • Cairns HospitalRecruiting
  • The Royal Brisbane and Women's HospitalRecruiting
  • ICON Cancer CareRecruiting
  • Toowoomba HospitalRecruiting
  • Genesis Care Tugun - John Flynn Private HospitalRecruiting
  • Wide Bay Hospital and Health Service - Cancer Care Services - Hervey BayRecruiting
  • Princess Alexandra HospitalRecruiting
  • Ashford Cancer Centre Research-Adelaide Cancer CentreRecruiting
  • Royal Hobart Hospital-Hobart HospitalRecruiting
  • Royal Hobart HospitalRecruiting
  • Bendigo HealthRecruiting
  • St. Vincent's HospitalRecruiting
  • Olivia Newton -John Cancer Wellness & Research CentreRecruiting
  • Peter Maccallum Cancer Centre (PMCC)Recruiting
  • Sir Charles Gairdner HospitalRecruiting
  • Royal Adelaide HospitalRecruiting
  • Liverpool Cancer Therapy CenterRecruiting
  • University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy CentreRecruiting
  • The Townsville Hospital and Health ServiceRecruiting
  • Universitair Ziekenhuis Leuven Gasthuisberg CampusRecruiting
  • Cliniques Universitaires Saint-LucRecruiting
  • Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade IRecruiting
  • Fundacao Pio XII - Hospital de Cancer de BarretosRecruiting
  • Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCARecruiting
  • Hospital Sao Vicente de Paulo (HSVP)Recruiting
  • Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRSRecruiting
  • Centro De Novos Tratamentos ItajaiRecruiting
  • ANIMIRecruiting
  • Centro Oncologico Mogi das CruzesRecruiting
  • Hospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USPRecruiting
  • Ynova pesquisa clinicaRecruiting
  • Instituto do Cancer do Estado de Sao Paulo - ICESPRecruiting
  • University Health Network- Princess Margaret Cancer CenterRecruiting
  • Centre Hospitalier Universitaire (CHU) de Dijon - Hopital du BocageRecruiting
  • Hopital Saint Andre - CHU de BordeauxRecruiting
  • Hopital Ambroise PareRecruiting
  • Centre Hospitalier Universitaire De Grenoble- Hopital Albert MichallonRecruiting
  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude HuriezRecruiting
  • Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)Recruiting
  • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel DieuRecruiting
  • Centre Hospitalier Universitaire de Nice,Hopital l ArchetRecruiting
  • Hospital Saint-Louis - APHPRecruiting
  • CIC Cochin Pasteur, Hopital CochinRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Centre Hospitalier Universitaire de Rouen-Hopital Charles NicolleRecruiting
  • Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEPRecruiting
  • NCT Dermatoonkologie -Hautklinik HeidelbergRecruiting
  • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeRRecruiting
  • Charite- Universitaetsmedizin BerlinRecruiting
  • Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB), St. Josef HospitalRecruiting
  • Elbekliniken BuxtehudeRecruiting
  • University Hospital DresdenRecruiting
  • Universitaetsklinikum Essen (AoR)Recruiting
  • SLK-Kliniken Heilbronn GmbHRecruiting
  • Universitaetsklinikum Schleswig-Holstein, Campus KielRecruiting
  • Klinikum der Universitaet zu KoelnRecruiting
  • LMU MunchenRecruiting
  • University Hospital TuebingenRecruiting
  • University of Athens - Hospital of Venereology Dermatology Diseases Andreas SyggrosRecruiting
  • Office of Dr. Aimilios Lallas MDRecruiting
  • St. Vincent's University HospitalRecruiting
  • University College Cork-Cork University Maternity HospitalRecruiting
  • University Hospital GalwayRecruiting
  • ASST Papa Giovanni XXIIIRecruiting
  • Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of BolognaRecruiting
  • ASST Spedali Civili BresciaRecruiting
  • University of BresciaRecruiting
  • Universita di Firenze - Azienda Sanitaria FirenzeRecruiting
  • University L'AquilaRecruiting
  • IRCCS-Istituto Europeo di OncologiaRecruiting
  • U.O.S.C Di Oncologia Medica E Terapie InnovativeRecruiting
  • A. Gemelli University Hospital, Catholic University of the Sacred HeartRecruiting
  • AOU Citta della Salute e della Scienza di TorinoRecruiting
  • Sapporo Medical University HospitalRecruiting
  • Shizuoka Cancer Center - OncologyRecruiting
  • National Cancer Center Hospital - Gastrointestinal OncologyRecruiting
  • Niigata Cancer Center HospitalRecruiting
  • Osaka International Cancer Institute - Clinical OncologyRecruiting
  • Regeneron Study Site
  • Palmerston North HospitalRecruiting
  • Narodowy Instytut Onkologii im. Marii Sk¿odowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w GliwicachRecruiting
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyRecruiting
  • State Healthcare Institution Oncology Dispensary 2 Ministry of Healthcare of Krasnodar Region
  • SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary
  • Regeneron Study Site
  • N.N.Blokhin Cancer Research Center
  • Regeneron Research Site
  • Federal State Budgetary Institution Rostov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation
  • Regeneron Study Site
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Universitario Fundacion AlcorconRecruiting
  • Hospital Universitario de TorrejonRecruiting
  • Catalan institute of Oncology BadalonaRecruiting
  • Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)Recruiting
  • Genesis Care hospital San Francisco de AsisRecruiting
  • Hospital General Universitario Gregorio Maranon (HGUGM)Recruiting
  • Clinica Universidad de NavarraRecruiting
  • Hospital Universitario 12 de Octubre-Centro de Actividades AmbulatoriasRecruiting
  • Hospital Universitario Puerta de Hierro de MajadahondaRecruiting
  • Hospital Clinico Universitario de SalamancaRecruiting
  • Hospital Universitario Virgen Macarena-mergeRecruiting
  • Instituto Valenciano de OncologíaRecruiting
  • Hospital Universitario y Politecnico La Fe-mergeRecruiting
  • Derriford HospitalRecruiting
  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer InstituteRecruiting
  • Velindre NHS Trust, Velindre Cancer CentreRecruiting
  • The Lothian University Hospitals NHS Lothian - Western General Hospital (WGH)Recruiting
  • Beatson West of Scotland Cancer Centre - Greater Glasgow Health BoardRecruiting
  • St George's Hospital - St George's University Hospitals NHS Foundation Trust
  • The Christie - The Christie NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cemiplimab

Placebo

Arm Description

Outcomes

Primary Outcome Measures

DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause.
For patients who do not have a tumor recurrence or death, DFS will be censored on the date of last disease assessment.

Secondary Outcome Measures

Overall survival (OS), defined as time from randomization to the date of death. A patient who has not died will be censored on the last known date as alive.
FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR). Patients who died without a preceding LRR will be censored on the date of death.
For patients who do not have a LRR or death, FFLRR will be censored on the date of last disease assessment.
Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death.
For patients who do not have a DR or death, FFDR will be censored on the date of last disease assessment.
Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study.
Incidence and severity of treatment-emergent adverse events (TEAE)
Incidence of deaths
Incidence of laboratory abnormalities
Cemiplimab concentrations in serum
Anti-drug antibodies (ADA) in serum

Full Information

First Posted
May 6, 2019
Last Updated
October 12, 2023
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03969004
Brief Title
Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
Official Title
A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
December 19, 2025 (Anticipated)
Study Completion Date
February 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi

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
The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT To assess cemiplimab pharmacokinetics and immunogenicity in human serum
Detailed Description
Cemiplimab is a monoclonal antibody. Antibodies are proteins naturally found in the blood. A monoclonal antibody is a special antibody that is manufactured as a medication to target specific proteins in the body that may be involved in cancer. Cemiplimab works by blocking programmed death-1 (PD-1), a cell receptor on immune cells. By blocking PD-1, it is expected that the immune cells will attack cancer cells. The study is being conducted in participants that have had surgery and radiation therapy for a type of skin cancer called cutaneous squamous cell cancer, and who have a risk that this cancer may come back. The main purpose of the study is to determine if cemiplimab will prevent cutaneous squamous cell cancer (CSCC) from returning after surgery and radiation. Currently, we know that certain types of CSCC have a high chance of coming back after surgery and radiation. At this time, there is no approved treatment to give patients after surgery and radiation to prevent high-risk CSCC from coming back. We are investigating if the addition of cemiplimab will decrease the chance of these high-risk cancers coming back. The study will also investigate if cemiplimab may help participants live for longer. The study has two parts. Part 1: participants will receive every 3 weeks via intravenous infusion (drip into a vein) either cemiplimab (study drug) or placebo (similar to the study drug but without active medicine). After 12 weeks of treatment, cemiplimab or placebo will be given every 6 weeks. Part 1 of the study includes a screening period (up to 28 days), a treatment period (approximately 48 weeks), an end of treatment visit (approximately 30 days after completion of study drug treatment period) and a post-treatment follow-up period (approximately up to 5 years or until skin cancer returns or the study ends). Part 2 of the study is optional and provides the participant with the option to receive cemiplimab if the cancer comes back if the participant was initially receiving placebo. There is no placebo in Part 2 of the study. If the cancer comes back, the study doctor will discuss with participants if they are eligible to participate in the optional part 2 of the study. Part 2 of the study includes a brief screening period, a treatment period (approximately 96 weeks) and an end of treatment visit (approximately 30 days after the completion of the study drug treatment period).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Squamous Cell Carcinoma
Keywords
High risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
412 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cemiplimab
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Other Intervention Name(s)
REGN2810, Libtayo
Intervention Description
Intravenous (IV) infusion over 30 minutes
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous (IV) infusion over 30 minutes
Primary Outcome Measure Information:
Title
DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause.
Description
For patients who do not have a tumor recurrence or death, DFS will be censored on the date of last disease assessment.
Time Frame
Up to 54 months
Secondary Outcome Measure Information:
Title
Overall survival (OS), defined as time from randomization to the date of death. A patient who has not died will be censored on the last known date as alive.
Time Frame
Up to 78 months
Title
FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR). Patients who died without a preceding LRR will be censored on the date of death.
Description
For patients who do not have a LRR or death, FFLRR will be censored on the date of last disease assessment.
Time Frame
Up to 54 months
Title
Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death.
Description
For patients who do not have a DR or death, FFDR will be censored on the date of last disease assessment.
Time Frame
Up to 54 months
Title
Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study.
Time Frame
Up to 54 months
Title
Incidence and severity of treatment-emergent adverse events (TEAE)
Time Frame
Up to 78 months
Title
Incidence of deaths
Time Frame
Up to 78 months
Title
Incidence of laboratory abnormalities
Time Frame
Up to 78 months
Title
Cemiplimab concentrations in serum
Time Frame
Up to 78 months
Title
Anti-drug antibodies (ADA) in serum
Time Frame
Up to 78 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: For Japan only, men and women ≥21 years old Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease High risk CSCC, as defined in the protocol Completion of curative intent post-operative radiation therapy (RT) within 2 to 10 weeks of randomization Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1 Adequate hepatic, renal, and bone marrow function as defined in the protocol Key Exclusion Criteria: Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol Patients with hematologic malignancies (note: patients with chronic lymphocytic leukemia (CLL) are not excluded if they have not required systemic therapy for CLL within 6 months of enrollment) Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary) Ongoing or recent (within 5 years of randomization date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment. Has had prior systemic anti-cancer immunotherapy for CSCC Note: Other protocol defined Inclusion/Exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Administrator
Phone
844-734-6643
Email
clinicaltrials@regeneron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
Regeneron Study Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Individual Site Status
Completed
Facility Name
The Angeles Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Completed
Facility Name
University of Southern California (USC)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0981
Country
United States
Individual Site Status
Completed
Facility Name
George Washington University School of Medicine and Health Sciences
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
032608
Country
United States
Individual Site Status
Completed
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Completed
Facility Name
Miami Cancer Institute at Baptist Health, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Regeneron Study Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Completed
Facility Name
Regeneron Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Completed
Facility Name
Regeneron Study Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Completed
Facility Name
Regeneron Study Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Completed
Facility Name
Massachusetts General Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber/Harvard Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Medicine- University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Missouri Health Care - University Physicians - Medicine Specialty Clinic
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University in Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Completed
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Regeneron Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Completed
Facility Name
The Ohio State University
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn State Hershey Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17025
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute - Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Baylor Charles A. Simmons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Completed
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
University Of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Name
The Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Individual Site Status
Recruiting
Facility Name
Coffs Harbour Health Campus
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Central Coast Cancer Centre-Gosford and Wyong Hospitals
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Individual Site Status
Recruiting
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Name
North Shore Private Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC)
City
Wagga Wagga
State/Province
New South Wales
ZIP/Postal Code
2650
Country
Australia
Individual Site Status
Recruiting
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Illawarra Cancer Care Centre (ICCC)
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Name
Wide Bay Hospital and Health Service - Cancer Care Services
City
Bundaberg
State/Province
Queensland
ZIP/Postal Code
4670
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cairns Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Recruiting
Facility Name
ICON Cancer Care
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Name
Toowoomba Hospital
City
Toowoomba
State/Province
Queensland
ZIP/Postal Code
4350
Country
Australia
Individual Site Status
Recruiting
Facility Name
Genesis Care Tugun - John Flynn Private Hospital
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Individual Site Status
Recruiting
Facility Name
Wide Bay Hospital and Health Service - Cancer Care Services - Hervey Bay
City
Urraween
State/Province
Queensland
ZIP/Postal Code
4655
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Ashford Cancer Centre Research-Adelaide Cancer Centre
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Hobart Hospital-Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Bendigo Health
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Individual Site Status
Recruiting
Facility Name
St. Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Olivia Newton -John Cancer Wellness & Research Centre
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter Maccallum Cancer Centre (PMCC)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Liverpool Cancer Therapy Center
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Townsville Hospital and Health Service
City
Townsville
ZIP/Postal Code
4814
Country
Australia
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Leuven Gasthuisberg Campus
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I
City
Ipatinga
State/Province
Minas Gerais
ZIP/Postal Code
35160-158
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos
City
Barretos
State/Province
Porte Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA
City
Santo Cristo
State/Province
Rio De Janiero
ZIP/Postal Code
20220-410
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Vicente de Paulo (HSVP)
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro De Novos Tratamentos Itajai
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Individual Site Status
Recruiting
Facility Name
ANIMI
City
Lajes
State/Province
Santa Catarina
ZIP/Postal Code
88501-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro Oncologico Mogi das Cruzes
City
Mogi das Cruzes
State/Province
Sao Paulo
ZIP/Postal Code
08730-500
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USP
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14049-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Ynova pesquisa clinica
City
Florianopolis
ZIP/Postal Code
88020-210
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
University Health Network- Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire (CHU) de Dijon - Hopital du Bocage
City
Dijon
State/Province
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Saint Andre - CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Ambroise Pare
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Nice,Hopital l Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
Hospital Saint-Louis - APHP
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Name
CIC Cochin Pasteur, Hopital Cochin
City
Paris
ZIP/Postal Code
7504
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
City
Rouen cedex
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
NCT Dermatoonkologie -Hautklinik Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite- Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB), St. Josef Hospital
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Name
Elbekliniken Buxtehude
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Essen (AoR)
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
SLK-Kliniken Heilbronn GmbH
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der Universitaet zu Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
LMU Munchen
City
Muenchen
ZIP/Postal Code
80337
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
University of Athens - Hospital of Venereology Dermatology Diseases Andreas Syggros
City
Athens
State/Province
Attiki
ZIP/Postal Code
16121
Country
Greece
Individual Site Status
Recruiting
Facility Name
Office of Dr. Aimilios Lallas MD
City
Thessaloniki
ZIP/Postal Code
546 23
Country
Greece
Individual Site Status
Recruiting
Facility Name
St. Vincent's University Hospital
City
Dublin
State/Province
Leinster
ZIP/Postal Code
DO4 YN63
Country
Ireland
Individual Site Status
Recruiting
Facility Name
University College Cork-Cork University Maternity Hospital
City
Cork
Country
Ireland
Individual Site Status
Recruiting
Facility Name
University Hospital Galway
City
Galway
ZIP/Postal Code
H91 YR71
Country
Ireland
Individual Site Status
Recruiting
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Spedali Civili Brescia
City
Brescia
ZIP/Postal Code
089263
Country
Italy
Individual Site Status
Recruiting
Facility Name
University of Brescia
City
Brescia
ZIP/Postal Code
25121
Country
Italy
Individual Site Status
Recruiting
Facility Name
Universita di Firenze - Azienda Sanitaria Firenze
City
Firenze
ZIP/Postal Code
50125
Country
Italy
Individual Site Status
Recruiting
Facility Name
University L'Aquila
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS-Istituto Europeo di Oncologia
City
Milan
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
U.O.S.C Di Oncologia Medica E Terapie Innovative
City
Napoli
ZIP/Postal Code
43100
Country
Italy
Individual Site Status
Recruiting
Facility Name
A. Gemelli University Hospital, Catholic University of the Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Citta della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shizuoka Cancer Center - Oncology
City
Nagaizumi-Cho
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital - Gastrointestinal Oncology
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka International Cancer Institute - Clinical Oncology
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Regeneron Study Site
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Completed
Facility Name
Palmerston North Hospital
City
Palmerston North
ZIP/Postal Code
4410
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Sk¿odowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach
City
Gliwice
ZIP/Postal Code
44-102
Country
Poland
Individual Site Status
Recruiting
Facility Name
Regeneron Study Site
City
Krakow
ZIP/Postal Code
30-820
Country
Poland
Individual Site Status
Completed
Facility Name
Regeneron Study Site
City
Poznan
ZIP/Postal Code
61-306
Country
Poland
Individual Site Status
Completed
Facility Name
Regeneron Study Site
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Completed
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
20-090
Country
Poland
Individual Site Status
Recruiting
Facility Name
State Healthcare Institution Oncology Dispensary 2 Ministry of Healthcare of Krasnodar Region
City
Sochi
State/Province
Krasnodar Krai
ZIP/Postal Code
354057
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary
City
Pyatigorsk
State/Province
Stavropol Region
ZIP/Postal Code
357502
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Regeneron Study Site
City
Magnitogorsk
ZIP/Postal Code
455001
Country
Russian Federation
Individual Site Status
Completed
Facility Name
N.N.Blokhin Cancer Research Center
City
Moscow
ZIP/Postal Code
33756
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Regeneron Research Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Federal State Budgetary Institution Rostov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation
City
Rostov-Na-Donu
ZIP/Postal Code
344037
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Regeneron Study Site
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Torrejon
City
Torrejon de Ardoz
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain
Individual Site Status
Recruiting
Facility Name
Catalan institute of Oncology Badalona
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Genesis Care hospital San Francisco de Asis
City
Madrid
ZIP/Postal Code
28002
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon (HGUGM)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro de Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena-merge
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario y Politecnico La Fe-merge
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Derriford Hospital
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute
City
Bristol
State/Province
Somerset
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Velindre NHS Trust, Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Lothian University Hospitals NHS Lothian - Western General Hospital (WGH)
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St George's Hospital - St George's University Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Individual Site Status
Completed
Facility Name
The Christie - The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4QL
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing Time Frame
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
IPD Sharing URL
https://vivli.org/

Learn more about this trial

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

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