Study NCT03132636
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
Submitted Date:  May 17, 2022 (v13)
Quality Control Review Has Not Concluded

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This submission includes brief standardized QC review comments added by the National Library of Medicine (NLM). These comments indicate the location of apparent errors, deficiencies, or inconsistencies. For more information, see the Final Rule (42 CFR Part 11) Information page.


Open or close this module Study Identification
Unique Protocol ID: R2810-ONC-1620
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
Secondary IDs: 2016-003122-16 [EudraCT Number]
Open or close this module Study Status
Record Verification: May 2022
Overall Status: Active, not recruiting
Study Start: June 29, 2017
Primary Completion: May 20, 2021 [Actual]
Study Completion: May 29, 2023 [Anticipated]
First Submitted: April 24, 2017
First Submitted that
Met QC Criteria:
April 24, 2017
First Posted: April 28, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: June 21, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Regeneron Pharmaceuticals
Responsible Party: Sponsor
Collaborators: Sanofi
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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
Detailed Description:
Open or close this module Conditions
Conditions: Carcinoma, Basal Cell
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 138 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1- metastatic BCC
Administration of cemiplimab in accordance with protocol dosing regimen
Drug: cemiplimab
Regimen as per protocol
Other Names:
  • REGN2810
  • Libtayo
Experimental: Group 2 - unresectable locally advanced BCC
Administration of cemiplimab in accordance with protocol dosing regimen
Drug: cemiplimab
Regimen as per protocol
Other Names:
  • REGN2810
  • Libtayo
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Objective Response Rates (ORR) as Assessed by Independent Central Review (ICR)
[ Time Frame: Up to 1422 days ]

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:
1. Duration of Response (DOR) Per ICR
[ Time Frame: Up to 40 months ]

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.
2. Duration of Response (DOR) Per Investigator Assessment
[ Time Frame: Up to 40 months ]

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.
3. Progression Free Survival (PFS) Determined by ICR
[ Time Frame: Up to 40 months ]

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.
4. Progression Free Survival (PFS) Determined by Investigator Assessment
[ Time Frame: Up to 40 months ]

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.
5. Overall Survival (OS)
[ Time Frame: Up to 40 months ]

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.
6. Percentage of Participants With Complete Response (CR) Rate Assessed by ICR
[ Time Frame: Up to 1422 days ]

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).
7. 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)
[ 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]) ]

EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, emotional, cognitive, social), symptoms (fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, and diarrhea) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate global health status and quality of life. All the scores and scales were transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. A negative change from baseline indicates a less improvement in the participants condition compared to the baseline.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
8. Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire
[ 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]) ]

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.
9. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
[ Time Frame: Up to 1422 days ]

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.
10. Serum Concentration at End of Infusion (Cmax) of Cemiplimab
[ 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) ]

Cmax of cemiplimab was reported.
11. Serum Concentration at Pre-infusion (Ctrough) of Cemiplimab
[ Time Frame: At pre-infusion on Cycle 1 Day 22 and Cycle 3 Day 1 (Each cycle of 9 weeks) ]

Ctrough of cemiplimab was reported.
12. Number of Participants With Anti-Drug Antibody (ADA) Status
[ Time Frame: Cycle 1: Days 1 and 43; Cycles 3 and 5: Day 1 (Each cycle of 9 weeks) ]

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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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

Open or close this module Contacts/Locations
Study Officials: Clinical Trial Management
Study Director
Regeneron Pharmaceuticals
Locations: United States, Arizona
The University of Arizona Cancer Centre at Dignity Health
Phoenix, Arizona, United States, 85004
Mayo Clinic Arizona - Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, California
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
Redwood City, California, United States, 94063-3132
UCSF Helen Dillion Family Cancer Care Center
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Hospital, Anschutz Outpatient Pavilion
Denver, Colorado, United States, 80045
United States, Florida
Mount Sinai Comprehensive Cancer Center
Miami, Florida, United States, 33140
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey, United States, 07962
Overlook Medical Center
Summit, New Jersey, United States, 07901
United States, New York
New York University School Of Medicine, Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Mount Sinai Hospital
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States, 29407
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Austria
Medizinische Universitaet Innsbruck, Universitaetsklinik fuer Dermatologie, Venerologie und Allergologie
Innsbruck, Austria, 6020
Austria, Steiermark
LKH - Universitaetsklinikum Graz
Graz, Steiermark, Austria, 8036
Belgium
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Odette Cancer Center-Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network
Toronto, Ontario, Canada, M5G 2M9
London Regional Cancer Program, London Hsc
Toronto, Ontario, Canada, N6A 4L6
France
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-André - Hôpital Saint-André
Bordeaux, France, 33000
Hopital Ambroise Pare
Boulogne Billancourt, France, 92100
Centre Hospitalier Universitaire de Grenoble
La Tronche, France, 38700
Hopital Huriez - CHRU de Lille
Lille Cedex, France, 59037
Centre Leon-Berard (CLB)
Lyon, France, 69008
CHU Hotel Dieu
Nantes, France, 44093
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
Rouen cedex, France, 76031
Institut Claudius Regaud
Toulouse Cedex, France, 31059
Institut Gustave Roussy
Villejuif Cedex, France, 94805
France, Cedex
CHU de Dijon - Hopital du Bocage
Dijon, Cedex, France, 21000
France, Europe
Hopital Saint Louis
Paris, Europe, France, 75010
France, Paris
Centre Hospitalier Lyon-Sud -Hospices Civils de Lyon Groupement Hospitalier Sud
Pierre Benite Cedex, Paris, France, 69495
Germany
Hauttumorcentrum der Charite (HTCC)-Charite Universitatsmedizin Berlin
Berlin, Germany, C-10117
Elbekliniken Buxtehude
Buxtehude, Germany, 21614
University Hospital Dresden
Dresden, Germany, 01307
Universitaetsklinik Essen
Essen, Germany, 45147
SRH Wald-Kliniken Gera GmbH
Gera, Germany, 07548
Hannover Medical School
Hannover, Germany, 30625
NCT Dermatoonkologie
Heidelberg, Germany, 69120
University of Kiel
Kiel, Germany, 24105
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Germany, 55131
Klinik Fur Dermatologie Und Allergollogie
Quedlinburg, Germany, 06484
University Hospital Tubingen
Tübingen, Germany, 72076
Germany, Hessen/Germany
University Hospital Frankfurt
Frankfurt, Hessen/Germany, Germany, 60590
Greece
National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
Athens, Greece, 115 27
National and Kapodistrian University of Athens - School of Health Sciences
Athens, Greece, 11527
Andreas Sygros Hosptial-University of Athen
Athens, Greece, 16121
University General Hospital of Ioannina - Dermatology and Venereology Department
Ioánnina, Greece, 45110
Italy
U.O.Dermatologia Azienda Sanitaria Firenze Universita' Firenze
Firenze, Italy, 50132
University L'Aquila
L'Aquila, Italy, 67100
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy, 20133
U.O.S.C Di Oncologia Medica E Terapie Innovative
Napoli, Italy, 80131
Catholic University of the S.Heart
Roma, Italy, 168
Italy, Bo
Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna
Bologna, Bo, Italy, 40138
Italy, Province Of Brescia
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
Brescia, Province Of Brescia, Italy, 25123
Spain
Catalan Institute of Oncology Badalona
Badalona, Spain, 08916
Hospital Clinic I Provincialde Barcelona
Barcelona, Spain, 08036
Hospital Universitario de Torrejon
Madrid, Spain, 28850
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Switzerland
University Hospital Zurich Usz
Zürich, Switzerland, 8091
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: July 29, 2019
Uploaded: 05/17/2022 15:56
File Name: Prot_000.pdf
Statistical Analysis Plan
Document Date: February 7, 2020
Uploaded: 05/17/2022 15:56
File Name: SAP_001.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details
Pre-assignment Details 138 of the 170 screened participants, were enrolled & treated. Eligible participants were enrolled into 2 groups. Group 1: participants with metastatic Basal Cell Carcinoma (mBCC). Group 2: participants with unresectable locally advanced BCC (laBCC) who experienced progression of disease on Hedgehog inhibitor (HHI) therapy, or response no better than stable disease for at least 9 months or were intolerant of prior HHI therapy. Results presented here based on primary analysis cut-off (20May2021).
 
Arm/Group Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group Description Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR. Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Period Title: Overall Study
Started 54 84
Completed 1 9
Not Completed 53 75
Reason Not Completed
Adverse Event 1 2
Death 4 7
Lost to Follow-up 2 2
Protocol Violation 1 1
Participant Decision 1 9
Sponsor Decision 0 1
Progressive disease 32 36
Withdrawal of consent 2 5
Study ongoing 9 10
Other 1 2
Open or close this module Baseline Characteristics
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)Total
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.Total of all reporting groups
Overall Number of Baseline Participants 54 84 138
Baseline Analysis Population Description
Age, Continuous
Mean (Standard Deviation)
Unit of measure: Years
Number Analyzed54 Participants84 Participants138 Participants
63.8(11.09)69.1(12.84)67.0(12.42)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed54 Participants84 Participants138 Participants
Female
16
29.63%
28
33.33%
44
31.88%
Male
38
70.37%
56
66.67%
94
68.12%
Race/Ethnicity, Customized
Measure Type: Number
Unit of measure: Participants
Number Analyzed54 Participants84 Participants138 Participants
Race : White
4757104
Race : Not Reported
101
Race : Missing
62733
Race/Ethnicity, Customized
Measure Type: Number
Unit of measure: Participants
Number Analyzed54 Participants84 Participants138 Participants
Ethnicity : Not Hispanic or Latino
4656102
Ethnicity : Hispanic or Latino
213
Ethnicity : Missing
62733
Open or close this module Outcome Measures
1. Primary Outcome:
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
Outcome Measure Data
Analysis Population Description
The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study.
 
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed54 84
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
24.1(13.5 to 37.6) 32.1(22.4 to 43.2)
2. Secondary Outcome:
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
Outcome Measure Data
Analysis Population Description
The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
 
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed13 27
Median (95% Confidence Interval)
Unit of Measure: Months
16.7(9.8 to NA) [1] NA(15.5 to NA) [1]
[1]NA Explanation: Data could not be estimated due to higher number (>50%) of censored participants.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The explanation provided is not sufficient to understand why one or more values are not available.
3. Secondary Outcome:
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
Outcome Measure Data
Analysis Population Description
The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
 
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed14 31
Median (95% Confidence Interval)
Unit of Measure: Months
19.3(9.8 to NA) [1] 19.6(16.7 to NA) [1]
[1]NA Explanation: Data could not be estimated due to higher number (>50%) of censored participants.
4. Secondary Outcome:
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
Outcome Measure Data
Analysis Population Description
The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
 
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed34 46
Median (95% Confidence Interval)
Unit of Measure: Months
8.3(4.2 to 15.9) 16.5(8.6 to 21.4)
5. Secondary Outcome:
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
Outcome Measure Data
Analysis Population Description
The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
 
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed41 52
Median (95% Confidence Interval)
Unit of Measure: Months
6.6(4.2 to 8.3) 17.1(10.3 to 19.8)
6. Secondary Outcome:
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
Outcome Measure Data
Analysis Population Description
The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study.
 
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed54 84
Median (95% Confidence Interval)
Unit of Measure: Months
NA(25.7 to NA) [1] NA(NA to NA) [1]
[1]NA Explanation: Data could not be estimated due to higher number (>50%) of censored participants.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The explanation provided is not sufficient to understand why one or more values are not available.
7. Secondary Outcome:
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
Outcome Measure Data
Analysis Population Description
The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study.
 
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed54 84
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
1.9(0.0 to 9.9) 7.1(2.7 to 14.9)
8. Secondary Outcome:
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 EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, emotional, cognitive, social), symptoms (fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, and diarrhea) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate global health status and quality of life. All the scores and scales were transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. A negative change from baseline indicates a less 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])

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
Outcome Measure Data
Analysis Population Description
The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at specific time points.
 
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed43 75
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Physical Functioning: Change at Cycle 2 Day 1
-4.88(14.274) -1.55(12.101)
Physical Functioning: Change at Cycle 3 Day 1
-1.78(13.481) -0.56(15.947)
Physical Functioning: Change at Cycle 4 Day 1
-6.60(12.828) -3.79(17.814)
Physical Functioning: Change at Cycle 5 Day 1
1.08(10.033) -2.86(17.063)
Physical Functioning: Change at Cycle 6 Day 1
-1.67(9.734) 0.33(12.073)
Physical Functioning: Change at Cycle 7 Day 1
-0.38(11.142) -0.20(15.410)
Physical Functioning: Change at Cycle 8 Day 1
-3.33(12.344) -3.03(13.549)
Physical Functioning: Change at Cycle 9 Day 1
-1.83(9.110) -5.06(20.444)
Role Functioning: Change at Cycle 2 Day 1
-2.71(27.442) -3.11(20.264)
Role Functioning: Change at Cycle 3 Day 1
5.17(27.854) -4.87(25.297)
Role Functioning: Change at Cycle 4 Day 1
-3.21(25.394) -6.06(26.326)
Role Functioning: Change at Cycle 5 Day 1
5.00(22.361) -5.33(26.393)
Role Functioning: Change at Cycle 6 Day 1
6.14(21.667) -3.33(16.963)
Role Functioning: Change at Cycle 7 Day 1
12.82(24.677) -7.07(16.682)
Role Functioning: Change at Cycle 8 Day 1
10.42(19.796) -4.04(19.557)
Role Functioning: Change at Cycle 9 Day 1
10.00(23.831) -9.77(30.052)
Emotional Functioning: Change at Cycle 2 Day 1
3.17(19.638) 1.95(20.483)
Emotional Functioning: Change at Cycle 3 Day 1
1.15(18.730) 1.56(18.538)
Emotional Functioning: Change at Cycle 4 Day 1
3.53(22.007) 1.39(21.277)
Emotional Functioning: Change at Cycle 5 Day 1
5.83(24.046) -4.59(19.622)
Emotional Functioning: Change at Cycle 6 Day 1
7.02(20.650) 1.04(19.809)
Emotional Functioning: Change at Cycle 7 Day 1
3.85(18.199) -4.63(19.576)
Emotional Functioning: Change at Cycle 8 Day 1
20.37(26.389) 3.11(19.810)
Emotional Functioning: Change at Cycle 9 Day 1
5.83(18.023) 2.11(17.246)
Cognitive Functioning: Change at Cycle 2 Day 1
0.78(13.586) -2.48(26.985)
Cognitive Functioning: Change at Cycle 3 Day 1
-1.72(16.871) -4.17(23.382)
Cognitive Functioning: Change at Cycle 4 Day 1
-0.64(15.261) -4.94(21.385)
Cognitive Functioning: Change at Cycle 5 Day 1
-4.17(14.178) -6.46(25.188)
Cognitive Functioning: Change at Cycle 6 Day 1
-0.88(12.998) -1.25(19.017)
Cognitive Functioning: Change at Cycle 7 Day 1
-2.56(11.479) -5.56(18.942)
Cognitive Functioning: Change at Cycle 8 Day 1
-7.41(12.108) 1.52(17.362)
Cognitive Functioning: Change at Cycle 9 Day 1
-11.67(26.117) -2.30(23.873)
Social Functioning: Change at Cycle 2 Day 1
0.39(19.412) 4.50(21.422)
Social Functioning: Change at Cycle 3 Day 1
3.45(16.891) 0.78(21.088)
Social Functioning: Change at Cycle 4 Day 1
3.85(24.179) 1.85(23.272)
Social Functioning: Change at Cycle 5 Day 1
3.33(22.685) 0.34(23.445)
Social Functioning: Change at Cycle 6 Day 1
10.53(16.860) 0.00(24.749)
Social Functioning: Change at Cycle 7 Day 1
12.82(22.724) 0.00(18.162)
Social Functioning: Change at Cycle 8 Day 1
12.96(16.197) 2.02(23.848)
Social Functioning: Change at Cycle 9 Day 1
10.00(14.055) -2.30(27.359)
Fatigue: Change at Cycle 2 Day 1
5.17(22.919) 6.44(24.542)
Fatigue: Change at Cycle 3 Day 1
1.92(18.322) 6.58(24.901)
Fatigue: Change at Cycle 4 Day 1
-2.56(21.154) 7.58(25.912)
Fatigue: Change at Cycle 5 Day 1
-5.56(24.048) 9.67(23.404)
Fatigue: Change at Cycle 6 Day 1
-5.85(19.376) 7.78(17.649)
Fatigue: Change at Cycle 7 Day 1
-1.71(19.692) 14.14(20.838)
Fatigue: Change at Cycle 8 Day 1
-12.50(22.567) 9.09(19.534)
Fatigue: Change at Cycle 9 Day 1
-1.11(16.932) 12.64(20.080)
Nausea/Vomiting: Change at Cycle 2 Day 1
-0.78(8.095) 0.22(12.703)
Nausea/Vomiting: Change at Cycle 3 Day 1
0.00(13.363) -1.79(12.884)
Nausea/Vomiting: Change at Cycle 4 Day 1
0.00(16.330) 0.30(13.414)
Nausea/Vomiting: Change at Cycle 5 Day 1
0.83(10.080) 1.00(13.640)
Nausea/Vomiting: Change at Cycle 6 Day 1
-0.88(3.824) 1.67(13.503)
Nausea/Vomiting: Change at Cycle 7 Day 1
-1.28(14.372) 3.03(13.472)
Nausea/Vomiting: Change at Cycle 8 Day 1
0.00(0.000) 0.51(12.832)
Nausea/Vomiting: Change at Cycle 9 Day 1
0.00(0.000) -2.30(13.890)
Pain: Change at Cycle 2 Day 1
-2.33(30.338) -0.22(26.351)
Pain: Change at Cycle 3 Day 1
-9.77(22.056) -1.54(30.151)
Pain: Change at Cycle 4 Day 1
0.00(29.439) -4.85(25.795)
Pain: Change at Cycle 5 Day 1
-4.17(25.291) -4.00(25.098)
Pain: Change at Cycle 6 Day 1
-14.04(29.535) -2.92(24.427)
Pain: Change at Cycle 7 Day 1
-21.79(29.174) -4.04(24.661)
Pain: Change at Cycle 8 Day 1
-14.81(28.191) -7.58(25.716)
Pain: Change at Cycle 9 Day 1
-21.67(28.382) -5.17(24.030)
Dyspnoea: Change at Cycle 2 Day 1
2.38(17.097) 1.33(24.162)
Dyspnoea: Change at Cycle 3 Day 1
3.57(16.578) -0.51(23.930)
Dyspnoea: Change at Cycle 4 Day 1
0.00(16.667) 2.42(24.724)
Dyspnoea: Change at Cycle 5 Day 1
3.51(21.928) 0.00(28.054)
Dyspnoea: Change at Cycle 6 Day 1
1.85(13.873) -1.67(19.900)
Dyspnoea: Change at Cycle 7 Day 1
2.78(30.011) 2.02(21.952)
Dyspnoea: Change at Cycle 8 Day 1
8.33(23.570) 2.02(21.952)
Dyspnoea: Change at Cycle 9 Day 1
7.41(27.778) 2.30(17.663)
Insomnia: Change at Cycle 2 Day 1
-2.33(26.622) 0.44(24.195)
Insomnia: Change at Cycle 3 Day 1
-6.90(24.200) -0.51(26.016)
Insomnia: Change at Cycle 4 Day 1
-10.26(29.468) -1.82(19.687)
Insomnia: Change at Cycle 5 Day 1
-15.00(31.484) 1.33(30.087)
Insomnia: Change at Cycle 6 Day 1
-17.54(32.142) -4.17(24.093)
Insomnia: Change at Cycle 7 Day 1
-7.69(41.172) 1.01(28.241)
Insomnia: Change at Cycle 8 Day 1
-25.00(52.705) 3.03(25.500)
Insomnia: Change at Cycle 9 Day 1
-6.67(40.976) 5.75(25.306)
Appetite loss: Change at Cycle 2 Day 1
4.65(26.807) -2.25(27.215)
Appetite loss: Change at Cycle 3 Day 1
-2.30(15.252) -4.30(22.163)
Appetite loss: Change at Cycle 4 Day 1
-1.28(30.523) -3.09(26.117)
Appetite loss: Change at Cycle 5 Day 1
3.33(21.357) -1.36(30.398)
Appetite loss: Change at Cycle 6 Day 1
-1.75(17.476) -2.56(29.004)
Appetite loss: Change at Cycle 7 Day 1
-5.13(12.518) -1.01(30.601)
Appetite loss: Change at Cycle 8 Day 1
-4.17(11.785) -2.08(31.609)
Appetite loss: Change at Cycle 9 Day 1
-3.33(18.922) 1.19(30.741)
Constipation: Change at Cycle 2 Day 1
1.55(19.181) 2.25(21.603)
Constipation: Change at Cycle 3 Day 1
0.00(21.822) 1.06(20.712)
Constipation: Change at Cycle 4 Day 1
-2.56(18.674) 1.23(21.440)
Constipation: Change at Cycle 5 Day 1
5.00(16.312) -0.68(22.037)
Constipation: Change at Cycle 6 Day 1
0.00(15.713) -1.67(18.413)
Constipation: Change at Cycle 7 Day 1
5.13(18.490) 4.04(13.838)
Constipation: Change at Cycle 8 Day 1
8.33(15.430) -2.02(16.540)
Constipation: Change at Cycle 9 Day 1
0.00(15.713) 1.15(22.683)
Diarrhea: Change at Cycle 2 Day 1
3.88(14.924) 0.45(24.360)
Diarrhea: Change at Cycle 3 Day 1
1.15(14.037) -1.04(20.547)
Diarrhea: Change at Cycle 4 Day 1
3.85(23.715) -1.85(19.870)
Diarrhea: Change at Cycle 5 Day 1
6.67(20.520) -0.68(23.064)
Diarrhea: Change at Cycle 6 Day 1
3.51(18.904) -1.67(18.413)
Diarrhea: Change at Cycle 7 Day 1
0.00(13.608) 1.01(19.516)
Diarrhea: Change at Cycle 8 Day 1
3.70(11.111) -1.01(19.516)
Diarrhea: Change at Cycle 9 Day 1
3.33(10.541) -2.30(21.696)
Financial Problems: Change at Cycle 2 Day 1
-3.10(17.539) -3.15(25.385)
Financial Problems: Change at Cycle 3 Day 1
0.00(18.144) -4.23(24.313)
Financial Problems: Change at Cycle 4 Day 1
-5.13(22.494) -4.94(23.710)
Financial Problems: Change at Cycle 5 Day 1
0.00(18.732) -6.80(22.546)
Financial Problems: Change at Cycle 6 Day 1
-1.75(23.501) -5.83(27.099)
Financial Problems: Change at Cycle 7 Day 1
-2.56(21.350) 1.01(19.516)
Financial Problems: Change at Cycle 8 Day 1
-3.70(20.031) 1.01(19.516)
Financial Problems: Change at Cycle 9 Day 1
-10.00(16.102) -2.30(23.454)
Global health status/QoL: Change at Cycle 2 Day 1
-3.68(21.845) 2.55(15.298)
Global health status/QoL: Change at Cycle 3 Day 1
3.74(14.362) -2.55(19.823)
Global health status/QoL: Change at Cycle 4 Day 1
-2.24(14.636) -0.49(18.136)
Global health status/QoL: Change at Cycle 5 Day 1
7.50(14.023) -1.91(21.210)
Global health status/QoL: Change at Cycle 6 Day 1
10.96(11.802) 4.17(19.447)
Global health status/QoL: Change at Cycle 7 Day 1
16.03(22.428) -3.13(19.715)
Global health status/QoL: Change at Cycle 8 Day 1
7.41(14.096) 2.15(21.727)
Global health status/QoL: Change at Cycle 9 Day 1
6.67(20.713) -7.14(28.211)
9. Secondary Outcome:
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])
Outcome Measure Data
Analysis Population Description
The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at specific time points.
   
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed42 71
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
 
Emotions: Change at Cycle 2 Day 1
Number Analyzed Participants Participants
-6.90(24.422) -8.93(27.767)
Emotions: Change at Cycle 3 Day 1
Number Analyzed Participants Participants
-7.92(18.033) -8.60(25.641)
Emotions: Change at Cycle 4 Day 1
Number Analyzed Participants Participants
-3.97(17.175) -11.45(24.215)
Emotions: Change at Cycle 5 Day 1
Number Analyzed Participants Participants
-0.14(12.835) -10.25(24.646)
Emotions: Change at Cycle 6 Day 1
Number Analyzed Participants Participants
-9.08(22.824) -19.73(27.304)
Emotions: Change at Cycle 7 Day 1
Number Analyzed Participants Participants
6.55(17.053) -13.65(27.132)
Emotions: Change at Cycle 8 Day 1
Number Analyzed Participants Participants
2.38(5.247) -13.97(25.001)
Emotions: Change at Cycle 9 Day 1
Number Analyzed Participants Participants
8.17(12.868) -15.08(31.843)
Symptoms: Change at Cycle 2 Day 1
Number Analyzed Participants Participants
0.99(18.788) -1.31(21.607)
Symptoms: Change at Cycle 3 Day 1
Number Analyzed Participants Participants
3.85(16.580) -0.26(24.158)
Symptoms: Change at Cycle 4 Day 1
Number Analyzed Participants Participants
5.30(18.464) -6.62(23.917)
Symptoms: Change at Cycle 5 Day 1
Number Analyzed Participants Participants
-0.98(15.205) -4.11(18.062)
Symptoms: Change at Cycle 6 Day 1
Number Analyzed Participants Participants
-1.56(16.307) -1.85(21.419)
Symptoms: Change at Cycle 7 Day 1
Number Analyzed Participants Participants
4.17(23.233) 0.69(24.518)
Symptoms: Change at Cycle 8 Day 1
Number Analyzed Participants Participants
6.77(18.222) -2.96(24.395)
Symptoms: Change at Cycle 9 Day 1
Number Analyzed Participants Participants
10.42(21.178) -3.42(24.455)
Functioning: Change at Cycle 2 Day 1
Number Analyzed Participants Participants
-3.49(19.183) -4.98(23.650)
Functioning: Change at Cycle 3 Day 1
Number Analyzed Participants Participants
-5.00(18.166) -4.76(20.203)
Functioning: Change at Cycle 4 Day 1
Number Analyzed Participants Participants
-8.18(24.119) -5.82(23.275)
Functioning: Change at Cycle 5 Day 1
Number Analyzed Participants Participants
-7.06(20.746) -3.76(16.369)
Functioning: Change at Cycle 6 Day 1
Number Analyzed Participants Participants
-12.08(27.022) -11.14(18.113)
Functioning: Change at Cycle 7 Day 1
Number Analyzed Participants Participants
-3.89(19.583) -6.00(15.767)
Functioning: Change at Cycle 8 Day 1
Number Analyzed Participants Participants
-8.33(26.367) -7.00(17.926)
Functioning: Change at Cycle 9 Day 1
Number Analyzed Participants Participants
-9.67(22.192) -5.60(20.965)
10. Secondary Outcome:
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
Outcome Measure Data
Analysis Population Description
The safety analysis set (SAF) included all enrolled participants who received any study drug for each group.
 
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed54 84
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with any TEAEs
51
94.4%
83
98.8%
Participants with any Serious TEAEs
16
29.6%
31
36.9%
11. Secondary Outcome:
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)
Outcome Measure Data
Analysis Population Description
The pharmacokinetics (PK) analysis set included all participants who received any cemiplimab and had at least one non-missing post-baseline measurement of cemiplimab concentration in serum. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
 
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed30 61
Mean (Standard Deviation)
Unit of Measure: Milligram per Liter (mg/L)
160(52.7) 192(91.6)
12. Secondary Outcome:
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)
Outcome Measure Data
Analysis Population Description
The PK analysis set included all participants who received any cemiplimab and had at least one non-missing post-baseline measurement of cemiplimab concentration in serum. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
 
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed32 66
Mean (Standard Deviation)
Unit of Measure: mg/L
60.6(28.2) 68.6(32.8)
13. Secondary Outcome:
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)
Outcome Measure Data
Analysis Population Description
The anti-drug antibody set included all participants who received cemiplimab and who had at least 1 non-missing result in the ADA assay after the first dose of the study drug.
 
Arm/Group TitleGroup 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group DescriptionParticipants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Number of Participants Analyzed52 81
Measure Type: Count of Participants
Unit of Measure: Participants
Negative ADA
50
96.2%
75
92.6%
Pre-Existing ADA
2
3.8%
2
2.5%
Treatment-emergent ADA
0
0%
4
4.9%
Open or close this module Adverse Events
 
Time Frame All Adverse Events (AEs) were collected from signature of the informed consent form up to 1422 days.
Adverse Event Reporting Description [Not specified]
 
Arm/Group Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Arm/Group Description Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or CR. Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 [each cycle of 9 weeks] followed by cycles 6-9 [each cycle of 12 weeks]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
All-Cause Mortality
  Group 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 16 / 54 (29.63%)17 / 84 (20.24%)
Serious Adverse Events
  Group 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 16 / 54 (29.63%)32 / 84 (38.1%)
Blood and lymphatic system disorders
Anaemia † A 0 / 54 (0%)02 / 84 (2.38%)3
Lymphadenopathy mediastinal † A 1 / 54 (1.85%)10 / 84 (0%)0
Pancytopenia † A 1 / 54 (1.85%)10 / 84 (0%)0
Cardiac disorders
Acute coronary syndrome † A 1 / 54 (1.85%)10 / 84 (0%)0
Atrial fibrillation † A 1 / 54 (1.85%)10 / 84 (0%)0
Autoimmune myocarditis † A 1 / 54 (1.85%)10 / 84 (0%)0
Autoimmune pericarditis † A 1 / 54 (1.85%)10 / 84 (0%)0
Cardiac failure † A 0 / 54 (0%)01 / 84 (1.19%)1
Immune-mediated myocarditis † A 1 / 54 (1.85%)10 / 84 (0%)0
Myocardial infarction † A 0 / 54 (0%)02 / 84 (2.38%)2
Supraventricular tachycardia † A 0 / 54 (0%)01 / 84 (1.19%)1
Ear and labyrinth disorders
Ear disorder † A 0 / 54 (0%)01 / 84 (1.19%)1
Endocrine disorders
Adrenal insufficiency † A 0 / 54 (0%)02 / 84 (2.38%)2
Hypophysitis † A 0 / 54 (0%)01 / 84 (1.19%)1
Gastrointestinal disorders
Autoimmune colitis † A 0 / 54 (0%)01 / 84 (1.19%)1
Colitis † A 2 / 54 (3.7%)22 / 84 (2.38%)2
Constipation † A 0 / 54 (0%)01 / 84 (1.19%)1
Erosive oesophagitis † A 0 / 54 (0%)01 / 84 (1.19%)1
General disorders
Fatigue † A 0 / 54 (0%)01 / 84 (1.19%)1
General physical health deterioration † A 1 / 54 (1.85%)10 / 84 (0%)0
Pyrexia † A 1 / 54 (1.85%)10 / 84 (0%)0
Hepatobiliary disorders
Autoimmune hepatitis † A 1 / 54 (1.85%)10 / 84 (0%)0
Immune-mediated hepatitis † A 0 / 54 (0%)01 / 84 (1.19%)1
Immune system disorders
Sarcoidosis † A 0 / 54 (0%)01 / 84 (1.19%)2
Infections and infestations
Arthritis bacterial † A 1 / 54 (1.85%)10 / 84 (0%)0
Atypical pneumonia † A 1 / 54 (1.85%)10 / 84 (0%)0
Clostridium difficile colitis † A 1 / 54 (1.85%)10 / 84 (0%)0
Clostridium difficile infection † A 1 / 54 (1.85%)10 / 84 (0%)0
Hepatitis C † A 0 / 54 (0%)01 / 84 (1.19%)1
Infection † A 1 / 54 (1.85%)10 / 84 (0%)0
Influenza † A 0 / 54 (0%)01 / 84 (1.19%)1
Lower respiratory tract infection † A 0 / 54 (0%)01 / 84 (1.19%)1
Oral candidiasis † A 0 / 54 (0%)01 / 84 (1.19%)1
Pneumonia † A 1 / 54 (1.85%)10 / 84 (0%)0
Pneumonia staphylococcal † A 1 / 54 (1.85%)10 / 84 (0%)0
Skin infection † A 1 / 54 (1.85%)10 / 84 (0%)0
Soft tissue infection † A 0 / 54 (0%)01 / 84 (1.19%)1
Subcutaneous abscess † A 0 / 54 (0%)01 / 84 (1.19%)1
Urinary tract infection † A 1 / 54 (1.85%)14 / 84 (4.76%)4
Wound infection staphylococcal † A 0 / 54 (0%)01 / 84 (1.19%)1
Injury, poisoning and procedural complications
Fall † A 1 / 54 (1.85%)10 / 84 (0%)0
Infusion related reaction † A 1 / 54 (1.85%)10 / 84 (0%)0
Multiple fractures † A 1 / 54 (1.85%)10 / 84 (0%)0
Procedural pain † A 1 / 54 (1.85%)10 / 84 (0%)0
Radial head dislocation † A 0 / 54 (0%)01 / 84 (1.19%)1
Tibia fracture † A 1 / 54 (1.85%)10 / 84 (0%)0
Upper limb fracture † A 0 / 54 (0%)01 / 84 (1.19%)1
Wound haemorrhage † A 1 / 54 (1.85%)10 / 84 (0%)0
Investigations
Weight decreased † A 0 / 54 (0%)01 / 84 (1.19%)1
Metabolism and nutrition disorders
Cachexia † A 0 / 54 (0%)01 / 84 (1.19%)2
Musculoskeletal and connective tissue disorders
Back pain † A 0 / 54 (0%)01 / 84 (1.19%)1
Dupuytren's contracture † A 0 / 54 (0%)01 / 84 (1.19%)1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma † A 0 / 54 (0%)01 / 84 (1.19%)1
Brain neoplasm malignant † A 0 / 54 (0%)01 / 84 (1.19%)1
Infected neoplasm † A 0 / 54 (0%)02 / 84 (2.38%)2
Lymphoproliferative disorder † A 1 / 54 (1.85%)10 / 84 (0%)0
Meningioma † A 0 / 54 (0%)01 / 84 (1.19%)1
Nervous system disorders
Brain oedema † A 0 / 54 (0%)01 / 84 (1.19%)1
Cerebrospinal fluid leakage † A 0 / 54 (0%)01 / 84 (1.19%)1
Cerebrovascular accident † A 0 / 54 (0%)01 / 84 (1.19%)1
Dizziness † A 0 / 54 (0%)01 / 84 (1.19%)1
Facial paralysis † A 1 / 54 (1.85%)10 / 84 (0%)0
Haemorrhage intracranial † A 0 / 54 (0%)01 / 84 (1.19%)1
Headache † A 1 / 54 (1.85%)10 / 84 (0%)0
Somnolence † A 1 / 54 (1.85%)21 / 84 (1.19%)1
Psychiatric disorders
Delirium † A 0 / 54 (0%)01 / 84 (1.19%)1
Renal and urinary disorders
Acute kidney injury † A 0 / 54 (0%)02 / 84 (2.38%)2
Urinary retention † A 1 / 54 (1.85%)10 / 84 (0%)0
Respiratory, thoracic and mediastinal disorders
Haemoptysis † A 1 / 54 (1.85%)10 / 84 (0%)0
Pleural effusion † A 1 / 54 (1.85%)10 / 84 (0%)0
Pneumonitis † A 1 / 54 (1.85%)10 / 84 (0%)0
Pulmonary oedema † A 0 / 54 (0%)01 / 84 (1.19%)1
Respiratory failure † A 1 / 54 (1.85%)10 / 84 (0%)0
Skin and subcutaneous tissue disorders
Dermal cyst † A 0 / 54 (0%)01 / 84 (1.19%)1
Vascular disorders
Hypertensive crisis † A 0 / 54 (0%)01 / 84 (1.19%)2
Hypotension † A 0 / 54 (0%)01 / 84 (1.19%)1
Peripheral ischaemia † A 0 / 54 (0%)01 / 84 (1.19%)1
Phlebitis † A 0 / 54 (0%)01 / 84 (1.19%)1
Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA 23.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
  Group 1: Metastatic BCC (mBCC)Group 2: Unresectable Locally Advanced BCC (laBCC)
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 50 / 54 (92.59%)75 / 84 (89.29%)
Blood and lymphatic system disorders
Anaemia † A 6 / 54 (11.11%)713 / 84 (15.48%)19
Leukocytosis † A 1 / 54 (1.85%)17 / 84 (8.33%)8
Endocrine disorders
Hyperthyroidism † A 5 / 54 (9.26%)72 / 84 (2.38%)2
Hypothyroidism † A 4 / 54 (7.41%)48 / 84 (9.52%)9
Eye disorders
Cataract † A 0 / 54 (0%)05 / 84 (5.95%)6
Gastrointestinal disorders
Abdominal pain † A 4 / 54 (7.41%)46 / 84 (7.14%)7
Constipation † A 12 / 54 (22.22%)145 / 84 (5.95%)6
Diarrhoea † A 20 / 54 (37.04%)2720 / 84 (23.81%)33
Dry mouth † A 3 / 54 (5.56%)33 / 84 (3.57%)3
Nausea † A 6 / 54 (11.11%)913 / 84 (15.48%)19
Vomiting † A 7 / 54 (12.96%)96 / 84 (7.14%)10
General disorders
Asthenia † A 5 / 54 (9.26%)617 / 84 (20.24%)27
Fatigue † A 23 / 54 (42.59%)3125 / 84 (29.76%)34
Influenza like illness † A 2 / 54 (3.7%)25 / 84 (5.95%)7
Oedema peripheral † A 6 / 54 (11.11%)85 / 84 (5.95%)5
Pain † A 3 / 54 (5.56%)42 / 84 (2.38%)2
Pyrexia † A 7 / 54 (12.96%)95 / 84 (5.95%)7
Infections and infestations
Bronchitis † A 0 / 54 (0%)06 / 84 (7.14%)7
Conjunctivitis † A 0 / 54 (0%)05 / 84 (5.95%)5
Upper respiratory tract infection † A 3 / 54 (5.56%)36 / 84 (7.14%)6
Urinary tract infection † A 4 / 54 (7.41%)510 / 84 (11.9%)11
Injury, poisoning and procedural complications
Fall † A 4 / 54 (7.41%)75 / 84 (5.95%)5
Infusion related reaction † A 3 / 54 (5.56%)30 / 84 (0%)0
Investigations
Alanine aminotransferase increased † A 3 / 54 (5.56%)34 / 84 (4.76%)6
Blood creatine phosphokinase increased † A 4 / 54 (7.41%)56 / 84 (7.14%)8
Blood creatinine increased † A 4 / 54 (7.41%)48 / 84 (9.52%)9
Weight decreased † A 5 / 54 (9.26%)67 / 84 (8.33%)7
Weight increased † A 8 / 54 (14.81%)122 / 84 (2.38%)2
Metabolism and nutrition disorders
Decreased appetite † A 6 / 54 (11.11%)614 / 84 (16.67%)18
Hyperglycaemia † A 6 / 54 (11.11%)82 / 84 (2.38%)2
Hypoalbuminaemia † A 1 / 54 (1.85%)25 / 84 (5.95%)11
Hypokalaemia † A 4 / 54 (7.41%)44 / 84 (4.76%)6
Musculoskeletal and connective tissue disorders
Arthralgia † A 9 / 54 (16.67%)1016 / 84 (19.05%)24
Back pain † A 5 / 54 (9.26%)55 / 84 (5.95%)6
Muscle spasms † A 3 / 54 (5.56%)35 / 84 (5.95%)5
Myalgia † A 3 / 54 (5.56%)43 / 84 (3.57%)3
Neck pain † A 4 / 54 (7.41%)42 / 84 (2.38%)4
Pain in extremity † A 6 / 54 (11.11%)104 / 84 (4.76%)5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma † A 3 / 54 (5.56%)57 / 84 (8.33%)8
Seborrhoeic keratosis † A 1 / 54 (1.85%)15 / 84 (5.95%)5
Tumour haemorrhage † A 1 / 54 (1.85%)19 / 84 (10.71%)12
Nervous system disorders
Dizziness † A 5 / 54 (9.26%)57 / 84 (8.33%)8
Headache † A 6 / 54 (11.11%)712 / 84 (14.29%)14
Psychiatric disorders
Anxiety † A 3 / 54 (5.56%)33 / 84 (3.57%)3
Renal and urinary disorders
Haematuria † A 4 / 54 (7.41%)53 / 84 (3.57%)3
Respiratory, thoracic and mediastinal disorders
Cough † A 4 / 54 (7.41%)510 / 84 (11.9%)14
Dyspnoea † A 4 / 54 (7.41%)511 / 84 (13.1%)17
Skin and subcutaneous tissue disorders
Actinic keratosis † A 3 / 54 (5.56%)36 / 84 (7.14%)9
Dermatitis † A 0 / 54 (0%)05 / 84 (5.95%)6
Dry skin † A 5 / 54 (9.26%)67 / 84 (8.33%)7
Eczema † A 5 / 54 (9.26%)75 / 84 (5.95%)5
Pruritus † A 8 / 54 (14.81%)1320 / 84 (23.81%)24
Rash † A 4 / 54 (7.41%)46 / 84 (7.14%)6
Rash maculo-papular † A 5 / 54 (9.26%)66 / 84 (7.14%)7
Vascular disorders
Hypertension † A 11 / 54 (20.37%)298 / 84 (9.52%)13
Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA 23.1
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact:
Name/Official Title:
Clinical Trials Administrator
Organization:
Regeneron Pharmaceuticals, Inc.
Phone:
844-734-6643
Email:
clinicaltrials@regeneron.com

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