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PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

Primary Purpose

Carcinoma, Basal Cell

Status
Completed
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 Carcinoma, Basal Cell

Eligibility Criteria

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

Key Inclusion Criteria:

  • Confirmed diagnosis of invasive BCC
  • Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI therapy
  • At least 1 measurable lesion
  • ≥18 years of age
  • Hepatic function, renal function, bone marrow function in defined lab-value-ranges
  • Anticipated life expectancy >12 weeks
  • Consent to provide archived tumor biopsy material (all patients)
  • Group 2: consent to undergo research biopsies
  • Group 2: must not be a candidate for radiation therapy or surgery
  • Comply with study procedures and site visits
  • Sign Subject Information Sheet and Informed Consent Form

Key Exclusion Criteria:

  • Ongoing or recent significant autoimmune disease
  • Prior treatment with specific pathway-blockers (PD-1/PD-L1)
  • Prior treatment with immune-modulating agents within 28 days before cemiplimab
  • Untreated brain metastasis that may be considered active
  • Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to treatment with cemiplimab
  • Active infections requiring therapy, including HIV, hepatitis
  • Pneumonitis within the last 5 years
  • Cancer treatment other than radiation therapy, including investigational or standard of care, within 30 days prior to treatment with cemiplimab
  • Documented allergic reactions or similar to antibody treatments
  • Concurrent malignancies other than BCC, other than those with negligible risk of metastases or death
  • Any acute or chronic psychiatric problems
  • Having received a solid organ transplantation
  • Inability to undergo contrast radiological assessments
  • Breastfeeding, pregnant, women of childbearing potential not using contraception

Note: Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • The University of Arizona Cancer Centre at Dignity Health
  • Mayo Clinic Arizona - Mayo Clinic Hospital
  • UC San Diego Moores Cancer Center
  • Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
  • UCSF Helen Dillion Family Cancer Care Center
  • University of Colorado Hospital, Anschutz Outpatient Pavilion
  • Mount Sinai Comprehensive Cancer Center
  • H Lee Moffitt Cancer Center and Research Institute
  • Northwestern Medical Faculty Foundation
  • Norton Cancer Institute
  • Massachusetts General Hospital
  • Dana Farber Cancer Institute (DFCI)
  • Washington University School of Medicine
  • Atlantic Health System / Morristown Medical Center
  • Overlook Medical Center
  • New York University School Of Medicine, Kaplan Comprehensive Cancer Center
  • Mount Sinai Hospital
  • Memorial Sloan Kettering Cancer Center
  • James Cancer Hospital and Solove Research Institute
  • Penn State Hershey Medical Center
  • Clinical Research Center of the Carolinas
  • University of Texas MD Anderson Cancer Center
  • Huntsman Cancer Institute
  • LKH - Universitaetsklinikum Graz
  • Medizinische Universitaet Innsbruck, Universitaetsklinik fuer Dermatologie, Venerologie und Allergologie
  • Cliniques Universitaires Saint-Luc
  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • Cross Cancer Institute
  • Odette Cancer Center-Sunnybrook Health Sciences Centre
  • University Health Network
  • London Regional Cancer Program, London Hsc
  • CHU de Dijon - Hopital du Bocage
  • Hopital Saint Louis
  • Centre Hospitalier Lyon-Sud -Hospices Civils de Lyon Groupement Hospitalier Sud
  • Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-André - Hôpital Saint-André
  • Hopital Ambroise Pare
  • Centre Hospitalier Universitaire de Grenoble
  • Hopital Huriez - CHRU de Lille
  • Centre Leon-Berard (CLB)
  • CHU Hotel Dieu
  • Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
  • Institut Claudius Regaud
  • Institut Gustave Roussy
  • University Hospital Frankfurt
  • Hauttumorcentrum der Charite (HTCC)-Charite Universitatsmedizin Berlin
  • Elbekliniken Buxtehude
  • University Hospital Dresden
  • Universitaetsklinik Essen
  • SRH Wald-Kliniken Gera GmbH
  • Hannover Medical School
  • NCT Dermatoonkologie
  • University of Kiel
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Klinik Fur Dermatologie Und Allergollogie
  • University Hospital Tubingen
  • National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
  • National and Kapodistrian University of Athens - School of Health Sciences
  • Andreas Sygros Hosptial-University of Athen
  • University General Hospital of Ioannina - Dermatology and Venereology Department
  • Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna
  • Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
  • U.O.Dermatologia Azienda Sanitaria Firenze Universita' Firenze
  • University L'Aquila
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • U.O.S.C Di Oncologia Medica E Terapie Innovative
  • Catholic University of the S.Heart
  • Catalan Institute of Oncology Badalona
  • Hospital Clinic I Provincialde Barcelona
  • Hospital Universitario de Torrejon
  • Hospital Universitario Virgen Macarena
  • University Hospital Zurich Usz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1- metastatic BCC

Group 2 - unresectable locally advanced BCC

Arm Description

Administration of cemiplimab in accordance with protocol dosing regimen

Administration of cemiplimab in accordance with protocol dosing regimen

Outcomes

Primary Outcome Measures

Objective Response Rates (ORR) as Assessed by Independent Central Review (ICR)
ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 assessed as per ICR assessment. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm) (< 1 centimeter [cm]). PR: At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. ORR was determined by Clopper-Pearson method.

Secondary Outcome Measures

Duration of Response (DOR) Per ICR
DOR per ICR was determined for participants with best overall response of CR or PR. DOR was measured from the time measurement criteria are first met for CR/PR (whichever was first recorded) until the first date of recurrent or progressive disease (PD) (photographic or radiographic), or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). DOR was determined by Kaplan-Meier estimate.
Duration of Response (DOR) Per Investigator Assessment
DOR per investigator assessment was determined for participants with best overall response of CR or PR. DOR was measured from the time measurement criteria are first met for CR/PR (whichever was first recorded) until the first date of recurrent or progressive disease (PD) (photographic or radiographic), or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). DOR was determined by Kaplan-Meier estimate.
Progression Free Survival (PFS) Determined by ICR
PFS was defined as the time from start of treatment until the first date of recurrent or PD (photographic or radiographic), or death due to any cause, whichever occurred first, was determined by IRC. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). PFS was determined by Kaplan-Meier estimate.
Progression Free Survival (PFS) Determined by Investigator Assessment
PFS was defined as the time from start of treatment until the first date of recurrent or PD (photographic or radiographic), or death due to any cause, whichever occurred first, was determined by IRC. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). PFS was determined by Kaplan-Meier estimate.
Overall Survival (OS)
OS was measured as time from the start of treatment until death due to any cause. Participants who do not die was censored at the last date that participant was documented to be alive. OS was calculated based on Kaplan-Meier method.
Percentage of Participants With Complete Response (CR) Rate Assessed by ICR
CR rate by ICR was determined by the percentage of participants with best overall response of CR. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm).
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall QoL in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the GHS/QoL, which are scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a higher score indicates higher ("better") quality of life/functioning and a positive change from baseline indicates improvement. For the symptom scales/items, a higher score indicates a higher ("worse") level of symptoms/problems, and a negative change from baseline indicates improvement.
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire
Skindex-16 questionnaire contains 16 questions related to quality of life in cancer participants. It consisted of a short 16-item assessment completed by the participant, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional & functional; their respective scores are expressed in a linear scale from 0 to 100. Symptoms scale score was an average of items 1 to 4 expressed in a linear scale from 0 to 100, Emotions scale score was an average of items 5 to 11 expressed in a linear scale from 0 to 100 and Functioning scale score was an average of items 12 to 16 expressed in a linear scale from 0 to 100. A negative change from baseline indicates an improvement in the participants condition compared to the baseline.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as AEs that developed or worsened during the on-treatment period and treatment-related AEs that occur during post-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs.
Serum Concentration at End of Infusion (Cmax) of Cemiplimab
Cmax of cemiplimab was reported.
Serum Concentration at Pre-infusion (Ctrough) of Cemiplimab
Ctrough of cemiplimab was reported.
Number of Participants With Anti-Drug Antibody (ADA) Status
Immunogenicity was characterized by ADA responses & titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses < 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, ≥ 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the cemiplimab ADA assay post first dose when baseline results = negative or missing.

Full Information

First Posted
April 24, 2017
Last Updated
June 14, 2023
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03132636
Brief Title
PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
Official Title
A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
April 27, 2023 (Actual)

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 is to estimate the objective response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with cemiplimab as a monotherapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Basal Cell

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group 1- metastatic BCC
Arm Type
Experimental
Arm Description
Administration of cemiplimab in accordance with protocol dosing regimen
Arm Title
Group 2 - unresectable locally advanced BCC
Arm Type
Experimental
Arm Description
Administration of cemiplimab in accordance with protocol dosing regimen
Intervention Type
Drug
Intervention Name(s)
cemiplimab
Other Intervention Name(s)
REGN2810, Libtayo
Intervention Description
Regimen as per protocol
Primary Outcome Measure Information:
Title
Objective Response Rates (ORR) as Assessed by Independent Central Review (ICR)
Description
ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 assessed as per ICR assessment. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm) (< 1 centimeter [cm]). PR: At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. ORR was determined by Clopper-Pearson method.
Time Frame
Up to 1422 days
Secondary Outcome Measure Information:
Title
Duration of Response (DOR) Per ICR
Description
DOR per ICR was determined for participants with best overall response of CR or PR. DOR was measured from the time measurement criteria are first met for CR/PR (whichever was first recorded) until the first date of recurrent or progressive disease (PD) (photographic or radiographic), or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). DOR was determined by Kaplan-Meier estimate.
Time Frame
Up to 40 months
Title
Duration of Response (DOR) Per Investigator Assessment
Description
DOR per investigator assessment was determined for participants with best overall response of CR or PR. DOR was measured from the time measurement criteria are first met for CR/PR (whichever was first recorded) until the first date of recurrent or progressive disease (PD) (photographic or radiographic), or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). DOR was determined by Kaplan-Meier estimate.
Time Frame
Up to 40 months
Title
Progression Free Survival (PFS) Determined by ICR
Description
PFS was defined as the time from start of treatment until the first date of recurrent or PD (photographic or radiographic), or death due to any cause, whichever occurred first, was determined by IRC. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). PFS was determined by Kaplan-Meier estimate.
Time Frame
Up to 40 months
Title
Progression Free Survival (PFS) Determined by Investigator Assessment
Description
PFS was defined as the time from start of treatment until the first date of recurrent or PD (photographic or radiographic), or death due to any cause, whichever occurred first, was determined by IRC. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). PFS was determined by Kaplan-Meier estimate.
Time Frame
Up to 40 months
Title
Overall Survival (OS)
Description
OS was measured as time from the start of treatment until death due to any cause. Participants who do not die was censored at the last date that participant was documented to be alive. OS was calculated based on Kaplan-Meier method.
Time Frame
Up to 40 months
Title
Percentage of Participants With Complete Response (CR) Rate Assessed by ICR
Description
CR rate by ICR was determined by the percentage of participants with best overall response of CR. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm).
Time Frame
Up to 1422 days
Title
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Description
The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall QoL in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the GHS/QoL, which are scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a higher score indicates higher ("better") quality of life/functioning and a positive change from baseline indicates improvement. For the symptom scales/items, a higher score indicates a higher ("worse") level of symptoms/problems, and a negative change from baseline indicates improvement.
Time Frame
Baseline (Day 1 of Cycle 1); Day 1 of Cycles 2 to 9 (Cycles 1-5 [Each cycle of 9 weeks], Cycles 6 to 9 [Each cycle of 12 weeks])
Title
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire
Description
Skindex-16 questionnaire contains 16 questions related to quality of life in cancer participants. It consisted of a short 16-item assessment completed by the participant, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional & functional; their respective scores are expressed in a linear scale from 0 to 100. Symptoms scale score was an average of items 1 to 4 expressed in a linear scale from 0 to 100, Emotions scale score was an average of items 5 to 11 expressed in a linear scale from 0 to 100 and Functioning scale score was an average of items 12 to 16 expressed in a linear scale from 0 to 100. A negative change from baseline indicates an improvement in the participants condition compared to the baseline.
Time Frame
Baseline (Day 1 of Cycle 1); Day 1 of Cycles 2 to 9 (Cycles 1-5 [Each cycle of 9 weeks], Cycles 6 to 9 [Each cycle of 12 weeks])
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Description
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as AEs that developed or worsened during the on-treatment period and treatment-related AEs that occur during post-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs.
Time Frame
Up to 1422 days
Title
Serum Concentration at End of Infusion (Cmax) of Cemiplimab
Description
Cmax of cemiplimab was reported.
Time Frame
At end-of-infusion (within 10 minutes after the end of infusion) on Cycle 1 Day 1 and Cycle 3 Day 1 (Each cycle of 9 weeks)
Title
Serum Concentration at Pre-infusion (Ctrough) of Cemiplimab
Description
Ctrough of cemiplimab was reported.
Time Frame
At pre-infusion on Cycle 1 Day 22 and Cycle 3 Day 1 (Each cycle of 9 weeks)
Title
Number of Participants With Anti-Drug Antibody (ADA) Status
Description
Immunogenicity was characterized by ADA responses & titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses < 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, ≥ 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the cemiplimab ADA assay post first dose when baseline results = negative or missing.
Time Frame
Cycle 1: Days 1 and 43; Cycles 3 and 5: Day 1 (Each cycle of 9 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Confirmed diagnosis of invasive BCC Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI therapy At least 1 measurable lesion ≥18 years of age Hepatic function, renal function, bone marrow function in defined lab-value-ranges Anticipated life expectancy >12 weeks Consent to provide archived tumor biopsy material (all patients) Group 2: consent to undergo research biopsies Group 2: must not be a candidate for radiation therapy or surgery Comply with study procedures and site visits Sign Subject Information Sheet and Informed Consent Form Key Exclusion Criteria: Ongoing or recent significant autoimmune disease Prior treatment with specific pathway-blockers (PD-1/PD-L1) Prior treatment with immune-modulating agents within 28 days before cemiplimab Untreated brain metastasis that may be considered active Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to treatment with cemiplimab Active infections requiring therapy, including HIV, hepatitis Pneumonitis within the last 5 years Cancer treatment other than radiation therapy, including investigational or standard of care, within 30 days prior to treatment with cemiplimab Documented allergic reactions or similar to antibody treatments Concurrent malignancies other than BCC, other than those with negligible risk of metastases or death Any acute or chronic psychiatric problems Having received a solid organ transplantation Inability to undergo contrast radiological assessments Breastfeeding, pregnant, women of childbearing potential not using contraception Note: 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
The University of Arizona Cancer Centre at Dignity Health
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Mayo Clinic Arizona - Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
City
Redwood City
State/Province
California
ZIP/Postal Code
94063-3132
Country
United States
Facility Name
UCSF Helen Dillion Family Cancer Care Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado Hospital, Anschutz Outpatient Pavilion
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
H Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern Medical Faculty Foundation
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 (DFCI)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Atlantic Health System / Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Overlook Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
New York University School Of Medicine, Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
James Cancer Hospital and Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Clinical Research Center of the Carolinas
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
University of Texas 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
LKH - Universitaetsklinikum Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universitaet Innsbruck, Universitaetsklinik fuer Dermatologie, Venerologie und Allergologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Odette Cancer Center-Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
London Regional Cancer Program, London Hsc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
CHU de Dijon - Hopital du Bocage
City
Dijon
State/Province
Cedex
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Saint Louis
City
Paris
State/Province
Europe
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Hospitalier Lyon-Sud -Hospices Civils de Lyon Groupement Hospitalier Sud
City
Pierre Benite Cedex
State/Province
Paris
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-André - Hôpital Saint-André
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hopital Ambroise Pare
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Centre Hospitalier Universitaire de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hopital Huriez - CHRU de Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Leon-Berard (CLB)
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
CHU Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
City
Rouen cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse Cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
University Hospital Frankfurt
City
Frankfurt
State/Province
Hessen/Germany
ZIP/Postal Code
60590
Country
Germany
Facility Name
Hauttumorcentrum der Charite (HTCC)-Charite Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
C-10117
Country
Germany
Facility Name
Elbekliniken Buxtehude
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
University Hospital Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinik Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
SRH Wald-Kliniken Gera GmbH
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Hannover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
NCT Dermatoonkologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University of Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinik Fur Dermatologie Und Allergollogie
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Facility Name
University Hospital Tubingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
National and Kapodistrian University of Athens - School of Health Sciences
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Andreas Sygros Hosptial-University of Athen
City
Athens
ZIP/Postal Code
16121
Country
Greece
Facility Name
University General Hospital of Ioannina - Dermatology and Venereology Department
City
Ioánnina
ZIP/Postal Code
45110
Country
Greece
Facility Name
Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna
City
Bologna
State/Province
Bo
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
City
Brescia
State/Province
Province Of Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
U.O.Dermatologia Azienda Sanitaria Firenze Universita' Firenze
City
Firenze
ZIP/Postal Code
50132
Country
Italy
Facility Name
University L'Aquila
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
U.O.S.C Di Oncologia Medica E Terapie Innovative
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Catholic University of the S.Heart
City
Roma
ZIP/Postal Code
168
Country
Italy
Facility Name
Catalan Institute of Oncology Badalona
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clinic I Provincialde Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de Torrejon
City
Madrid
ZIP/Postal Code
28850
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
University Hospital Zurich Usz
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34000246
Citation
Stratigos AJ, Sekulic A, Peris K, Bechter O, Prey S, Kaatz M, Lewis KD, Basset-Seguin N, Chang ALS, Dalle S, Orland AF, Licitra L, Robert C, Ulrich C, Hauschild A, Migden MR, Dummer R, Li S, Yoo SY, Mohan K, Coates E, Jankovic V, Fiaschi N, Okoye E, Bassukas ID, Loquai C, De Giorgi V, Eroglu Z, Gutzmer R, Ulrich J, Puig S, Seebach F, Thurston G, Weinreich DM, Yancopoulos GD, Lowy I, Bowler T, Fury MG. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):848-857. doi: 10.1016/S1470-2045(21)00126-1. Epub 2021 May 14.
Results Reference
derived
PubMed Identifier
31585957
Citation
Li R, Lee G, Huang M, El-Sherief A. Rare basal cell metastasis of a basal-squamous skin collision tumour to the lung and axillary lymph node. BMJ Case Rep. 2019 Oct 3;12(10):e231487. doi: 10.1136/bcr-2019-231487.
Results Reference
derived

Learn more about this trial

PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

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