search
Back to results

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Primary Purpose

Advanced Cutaneous Squamous Cell Carcinoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cemiplimab
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cutaneous Squamous Cell Carcinoma focused on measuring Metastatic CSCC, Unresectable locally advanced CSCC

Eligibility Criteria

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

Key Inclusion Criteria:

  • At least 1 measurable lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Adequate bone marrow function
  • Adequate renal function
  • Adequate hepatic function
  • Archived or newly obtained tumor material
  • Patients must consent to undergo biopsies of CSCC lesions (Groups 2, 4, and 6)
  • Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
  • Prior treatment with an agent that blocks the PD-1/PD-L1pathway
  • Prior treatment with a BRAF inhibitor
  • Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab, or associated with immune-mediated adverse events that were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, or associated with toxicity that resulted in discontinuation of the immune-modulating agent. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.
  • Untreated brain metastasis(es) that may be considered active
  • Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab
  • Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus
  • History of non-infectious pneumonitis within the last 5 years
  • Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
  • Known allergy to doxycycline or tetracycline
  • Patients with a history of solid organ transplant
  • Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that renders the patient unsuitable

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • University of Arizona Cancer Center
  • Mayo Clinic
  • City of Hope Hospital
  • University of California, Los Angeles
  • Stanford University
  • University of California, San Diego
  • University of Colorado, Denver
  • Mount Sinai Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center
  • Northwestern University
  • Norton Cancer Institute
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Barbara Ann Karmanos Cancer Institute
  • St. Louis University
  • Washington University in St. Louis
  • Nebraska Methodist Hospital
  • New York University
  • Memorial Sloan Kettering Cancer Center
  • University of Rochester Medical Center
  • Cleveland Clinic
  • St. Luke's Hematology Oncology Specialists
  • Penn State Hershey Medical Center
  • Dermatology and Laser Center of Charleston
  • MD Anderson Cancer Center
  • Huntsman Cancer Institute
  • The Canberra Hospital
  • Gosford Hospital
  • Royal North Shore Hospital
  • Calvary Mater Newcastle
  • Royal Brisbane & Women's Hospital
  • Princess Alexandra Hospital
  • Adelaide Cancer Centre
  • Peter MacCallum Cancer Centre
  • Border Medical Oncology
  • Sir Charles Gairdner Hospital
  • Hospital de Clinicas de Porto Alegre
  • Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
  • Fundação São Francisco Xavier-Hospital Márcio Cunha
  • Animi
  • Instituto do Cancer do Estado de São Paulo ICESP
  • Fundação Antônio Prudente - AC Camargo Câncer Center
  • Hôpital Claude Huriez
  • Hopital Avicenne
  • Hôpital Saint-André
  • CHU Dijon Bourgogne
  • CHRU Grenoble
  • Hopitaux de La Timone
  • Centre Hospitalier Universitaire de Nantes
  • Hopital Cochin
  • Hôpital Saint Louis
  • Centre Hospitalier Lyon Sud
  • Institut Gustave Roussy
  • Universitätsklinikum Tübingen
  • LMU Klinikum der Universität München
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Essen
  • Universitätsklinikum Carl Gustav Carus
  • Universitatsklinikum Schleswig-Holstein
  • Charitè Campus Mitte
  • SRH Wald-Klinikum Gera
  • Andreas Sygros Hosptial-University of Athen
  • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
  • Istituto Oncologico Veneto - I.R.C.C.S.
  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
  • Ospedale San Salvatore
  • Istituto Europeo Di Oncologia
  • Fondazione Policlinico Universitario A Gemelli
  • ICO l'Hospitalet - Hospital Duran i Reynals
  • Hospital Clinic de Barcelona
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitario Germans Trias i Pujol
  • C.H. Regional Reina Sofia - PPDS
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario Fundacion Jimenez Diaz
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Marques de Valdecilla
  • Fundacion Instituto Valenciano de Oncología

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 6

Arm Description

Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously (IV) every 2 weeks (Q2W).

Patients with unresectable locally advanced CSCC. Cemiplimab administered IV Q2 weeks.

Patients with metastatic CSCC to distant sites or lymph nodes. Cemiplimab administered IV Q3 weeks.

Patients with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] Cemplimab administered IV Q4 weeks.

Patients with advanced CSCC (metastatic [nodal or distant] or locally advanced) who received cemiplimab IV Q3W for at least 27 weeks without experiencing disease progression, will have the option to receive cemiplimab by subcutaneous (SC) injection Q3W (first 12 patients) or Q6W (next ≥ 6 patients) basis.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
Groups 1, 3, 4, and 6: Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 will be used to determine ORR. Group 2: Clinical response criteria will be used to determine ORR

Secondary Outcome Measures

Investigator Assessments of ORR
Groups 1-4, and 6
Duration of response
Groups 1-4, and 6
PFS (progression-free survival)
Groups 1-4, and 6
Overall Survival
Groups 1-4, and 6
Complete Response (CR) Rate
Groups 1-4, and 6
Change in scores of patient reported outcomes on EORTC QLQ-C30
Except Group 6
Incidence of Treatment Emergent Adverse Events (TEAEs)
Cemiplimab PK: Concentration at end-of-infusion (Ceoi) (IV)
Cemiplimab PK: Peak concentrations (Cmax) (SC)
Cemiplimab PK: Pre-infusion concentration (Ctrough)
Cemiplimab PK: Time of end-of-infusion (teoi)
Cemiplimab PK: Time to peak concentration (tmax) (SC)
Cemiplimab PK: Area under the plasma concentration-time curve after the first SC or IV dose
Cemiplimab PK: Absolute bioavailability after SC administration
Anti-cemiplimab antibodies
Immunohistochemistry (IHC) assessment of correlation between PD-L1 status and ORR
Group 6
IHC assessment of correlation between PD-L1 and DOR
Group 6
IHC assessment of correlation between PD-L1 and PFS
Group 6

Full Information

First Posted
April 8, 2016
Last Updated
January 4, 2023
Sponsor
Regeneron Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT02760498
Brief Title
Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Official Title
A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 7, 2016 (Actual)
Primary Completion Date
October 19, 2023 (Anticipated)
Study Completion Date
October 19, 2023 (Anticipated)

3. Sponsor/Collaborators

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

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
Groups 1 to 4 To estimate the clinical benefit of cemiplimab monotherapy for patients with: metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC Group 6 To provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced treated with cemiplimab

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cutaneous Squamous Cell Carcinoma
Keywords
Metastatic CSCC, Unresectable locally advanced CSCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously (IV) every 2 weeks (Q2W).
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Patients with unresectable locally advanced CSCC. Cemiplimab administered IV Q2 weeks.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Patients with metastatic CSCC to distant sites or lymph nodes. Cemiplimab administered IV Q3 weeks.
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Patients with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] Cemplimab administered IV Q4 weeks.
Arm Title
Group 6
Arm Type
Experimental
Arm Description
Patients with advanced CSCC (metastatic [nodal or distant] or locally advanced) who received cemiplimab IV Q3W for at least 27 weeks without experiencing disease progression, will have the option to receive cemiplimab by subcutaneous (SC) injection Q3W (first 12 patients) or Q6W (next ≥ 6 patients) basis.
Intervention Type
Drug
Intervention Name(s)
cemiplimab
Other Intervention Name(s)
REGN2810, Libtayo
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Groups 1, 3, 4, and 6: Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 will be used to determine ORR. Group 2: Clinical response criteria will be used to determine ORR
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Investigator Assessments of ORR
Description
Groups 1-4, and 6
Time Frame
Up to 30 months
Title
Duration of response
Description
Groups 1-4, and 6
Time Frame
Up to 30 months
Title
PFS (progression-free survival)
Description
Groups 1-4, and 6
Time Frame
Up to 30 months
Title
Overall Survival
Description
Groups 1-4, and 6
Time Frame
Up to 30 months
Title
Complete Response (CR) Rate
Description
Groups 1-4, and 6
Time Frame
Up to 30 months
Title
Change in scores of patient reported outcomes on EORTC QLQ-C30
Description
Except Group 6
Time Frame
Up to 30 months
Title
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame
Up to 30 months
Title
Cemiplimab PK: Concentration at end-of-infusion (Ceoi) (IV)
Time Frame
Up to 24 months
Title
Cemiplimab PK: Peak concentrations (Cmax) (SC)
Time Frame
Up to 24 months
Title
Cemiplimab PK: Pre-infusion concentration (Ctrough)
Time Frame
Up to 24 months
Title
Cemiplimab PK: Time of end-of-infusion (teoi)
Time Frame
Up to 24 months
Title
Cemiplimab PK: Time to peak concentration (tmax) (SC)
Time Frame
Up to 24 months
Title
Cemiplimab PK: Area under the plasma concentration-time curve after the first SC or IV dose
Time Frame
Up to 24 months
Title
Cemiplimab PK: Absolute bioavailability after SC administration
Time Frame
Up to 24 months
Title
Anti-cemiplimab antibodies
Time Frame
Up to 30 months
Title
Immunohistochemistry (IHC) assessment of correlation between PD-L1 status and ORR
Description
Group 6
Time Frame
Up to 30 months
Title
IHC assessment of correlation between PD-L1 and DOR
Description
Group 6
Time Frame
Up to 30 months
Title
IHC assessment of correlation between PD-L1 and PFS
Description
Group 6
Time Frame
Up to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: At least 1 measurable lesion Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Adequate bone marrow function Adequate renal function Adequate hepatic function Archived or newly obtained tumor material Patients must consent to undergo biopsies of CSCC lesions (Groups 2, 4, and 6) Surgical or radiological treatment of lesions contraindicated Key Exclusion Criteria: Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events Prior treatment with an agent that blocks the PD-1/PD-L1pathway Prior treatment with a BRAF inhibitor Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab, or associated with immune-mediated adverse events that were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, or associated with toxicity that resulted in discontinuation of the immune-modulating agent. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40. Untreated brain metastasis(es) that may be considered active Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus History of non-infectious pneumonitis within the last 5 years Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments Known allergy to doxycycline or tetracycline Patients with a history of solid organ transplant Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that renders the patient unsuitable Other protocol-defined inclusion/exclusion criteria apply
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
University of Arizona Cancer Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
City of Hope Hospital
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
University of Colorado, Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St. Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
St. Luke's Hematology Oncology Specialists
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Dermatology and Laser Center of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Gosford Hospital
City
Gosford
State/Province
New South Wales
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Adelaide Cancer Centre
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Border Medical Oncology
City
Wodonga
State/Province
Victoria
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
City
Curitiba
Country
Brazil
Facility Name
Fundação São Francisco Xavier-Hospital Márcio Cunha
City
Ipatinga
Country
Brazil
Facility Name
Animi
City
Lages
Country
Brazil
Facility Name
Instituto do Cancer do Estado de São Paulo ICESP
City
Sao Paulo
Country
Brazil
Facility Name
Fundação Antônio Prudente - AC Camargo Câncer Center
City
São Paulo
Country
Brazil
Facility Name
Hôpital Claude Huriez
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Hôpital Saint-André
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHRU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopitaux de La Timone
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94085
Country
France
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
LMU Klinikum der Universität München
City
Munich
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Charitè Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
SRH Wald-Klinikum Gera
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Andreas Sygros Hosptial-University of Athen
City
Athens
ZIP/Postal Code
16121
Country
Greece
Facility Name
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
City
Napoli
State/Province
Campania
Country
Italy
Facility Name
Istituto Oncologico Veneto - I.R.C.C.S.
City
Padova
State/Province
Veneto
Country
Italy
Facility Name
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
Ospedale San Salvatore
City
L'Aquila
Country
Italy
Facility Name
Istituto Europeo Di Oncologia
City
Milan
Country
Italy
Facility Name
Fondazione Policlinico Universitario A Gemelli
City
Roma
Country
Italy
Facility Name
ICO l'Hospitalet - Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
State/Province
Barelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
C.H. Regional Reina Sofia - PPDS
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Fundacion Instituto Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
34413166
Citation
Rischin D, Khushalani NI, Schmults CD, Guminski A, Chang ALS, Lewis KD, Lim AM, Hernandez-Aya L, Hughes BGM, Schadendorf D, Hauschild A, Thai AA, Stankevich E, Booth J, Yoo SY, Li S, Chen Z, Okoye E, Chen CI, Mastey V, Sasane M, Lowy I, Fury MG, Migden MR. Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis. J Immunother Cancer. 2021 Aug;9(8):e002757. doi: 10.1136/jitc-2021-002757.
Results Reference
derived
PubMed Identifier
33768419
Citation
Paccaly AJ, Migden MR, Papadopoulos KP, Yang F, Davis JD, Rippley RK, Lowy I, Fury MG, Stankevich E, Rischin D. Fixed Dose of Cemiplimab in Patients with Advanced Malignancies Based on Population Pharmacokinetic Analysis. Adv Ther. 2021 May;38(5):2365-2378. doi: 10.1007/s12325-021-01638-5. Epub 2021 Mar 25.
Results Reference
derived
PubMed Identifier
32554615
Citation
Rischin D, Migden MR, Lim AM, Schmults CD, Khushalani NI, Hughes BGM, Schadendorf D, Dunn LA, Hernandez-Aya L, Chang ALS, Modi B, Hauschild A, Ulrich C, Eigentler T, Stein B, Pavlick AC, Geiger JL, Gutzmer R, Alam M, Okoye E, Mathias M, Jankovic V, Stankevich E, Booth J, Li S, Lowy I, Fury MG, Guminski A. Phase 2 study of cemiplimab in patients with metastatic cutaneous squamous cell carcinoma: primary analysis of fixed-dosing, long-term outcome of weight-based dosing. J Immunother Cancer. 2020 Jun;8(1):e000775. doi: 10.1136/jitc-2020-000775.
Results Reference
derived
PubMed Identifier
31952975
Citation
Migden MR, Khushalani NI, Chang ALS, Lewis KD, Schmults CD, Hernandez-Aya L, Meier F, Schadendorf D, Guminski A, Hauschild A, Wong DJ, Daniels GA, Berking C, Jankovic V, Stankevich E, Booth J, Li S, Weinreich DM, Yancopoulos GD, Lowy I, Fury MG, Rischin D. Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. Lancet Oncol. 2020 Feb;21(2):294-305. doi: 10.1016/S1470-2045(19)30728-4. Epub 2020 Jan 14.
Results Reference
derived
PubMed Identifier
29863979
Citation
Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.
Results Reference
derived

Learn more about this trial

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

We'll reach out to this number within 24 hrs