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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

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ClinicalTrials.gov Identifier: NCT03132636
Recruitment Status : Active, not recruiting
First Posted : April 28, 2017
Results First Posted : July 26, 2022
Last Update Posted : July 26, 2022
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Basal Cell
Intervention Drug: cemiplimab
Enrollment 138
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)
Hide 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
Arm/Group Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC) Total
Hide 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. Total of all reporting groups
Overall Number of Baseline Participants 54 84 138
Hide Baseline Analysis Population Description
The full analysis set (FAS) included all enrolled participants for each group who passed screening and were deemed to be eligible for this study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 84 participants 138 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 Analyzed 54 participants 84 participants 138 participants
Female
16
  29.6%
28
  33.3%
44
  31.9%
Male
38
  70.4%
56
  66.7%
94
  68.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants 84 participants 138 participants
Race : White 47 57 104
Race : Not Reported 1 0 1
Race : Missing 6 27 33
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants 84 participants 138 participants
Ethnicity : Not Hispanic or Latino 46 56 102
Ethnicity : Hispanic or Latino 2 1 3
Ethnicity : Missing 6 27 33
1.Primary Outcome
Title Objective Response Rates (ORR) as Assessed by Independent Central Review (ICR)
Hide 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
Hide Outcome Measure Data
Hide 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 Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 54 84
Measure Type: Number
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
Hide 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
Hide Outcome Measure Data
Hide 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 Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 13 27
Median (95% Confidence Interval)
Unit of Measure: Months
16.7 [1] 
(9.8 to NA)
NA [1] 
(15.5 to NA)
[1]
mBCC: The upper limit of the 95% confidence interval could not be estimated because 53.8% of patients were censored. laBCC: Because 70.4% of patients were censored and there was a greater than 50% chance of surviving at follow-up, the median survival and upper bounds of the 95% confidence interval could not be estimated.
3.Secondary Outcome
Title Duration of Response (DOR) Per Investigator Assessment
Hide 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
Hide Outcome Measure Data
Hide 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 Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 14 31
Median (95% Confidence Interval)
Unit of Measure: Months
19.3 [1] 
(9.8 to NA)
19.6 [1] 
(16.7 to NA)
[1]
Data could not be estimated due to higher number (>50%) of censored participants.
4.Secondary Outcome
Title Progression Free Survival (PFS) Determined by ICR
Hide 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
Hide Outcome Measure Data
Hide 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 Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 34 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
Hide 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
Hide Outcome Measure Data
Hide 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 Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 41 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)
Hide 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
Hide Outcome Measure Data
Hide 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 Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 54 84
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(25.7 to NA)
NA [1] 
(NA to NA)
[1]
mBCC: Because 70.4% of patients were censored and there was a greater than 50% chance of surviving at follow-up, the median overall survival and upper bound of the 95% confidence interval could not be estimated. laBCC: Because 79.8% of patients were censored and there was a greater than 50% chance of surviving at follow-up, the median overall survival and lower and upper bounds of the 95% confidence interval could not be estimated.
7.Secondary Outcome
Title Percentage of Participants With Complete Response (CR) Rate Assessed by ICR
Hide 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
Hide Outcome Measure Data
Hide 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 Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 54 84
Measure Type: Number
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)
Hide 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])
Hide Outcome Measure Data
Hide 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 Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 43 75
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Physical Functioning: Change at Cycle 2 Day 1 Number Analyzed 43 participants 75 participants
-4.88  (14.274) -1.55  (12.101)
Physical Functioning: Change at Cycle 3 Day 1 Number Analyzed 29 participants 65 participants
-1.78  (13.481) -0.56  (15.947)
Physical Functioning: Change at Cycle 4 Day 1 Number Analyzed 26 participants 55 participants
-6.60  (12.828) -3.79  (17.814)
Physical Functioning: Change at Cycle 5 Day 1 Number Analyzed 20 participants 50 participants
1.08  (10.033) -2.86  (17.063)
Physical Functioning: Change at Cycle 6 Day 1 Number Analyzed 19 participants 40 participants
-1.67  (9.734) 0.33  (12.073)
Physical Functioning: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
-0.38  (11.142) -0.20  (15.410)
Physical Functioning: Change at Cycle 8 Day 1 Number Analyzed 8 participants 33 participants
-3.33  (12.344) -3.03  (13.549)
Physical Functioning: Change at Cycle 9 Day 1 Number Analyzed 10 participants 29 participants
-1.83  (9.110) -5.06  (20.444)
Role Functioning: Change at Cycle 2 Day 1 Number Analyzed 43 participants 75 participants
-2.71  (27.442) -3.11  (20.264)
Role Functioning: Change at Cycle 3 Day 1 Number Analyzed 29 participants 65 participants
5.17  (27.854) -4.87  (25.297)
Role Functioning: Change at Cycle 4 Day 1 Number Analyzed 26 participants 55 participants
-3.21  (25.394) -6.06  (26.326)
Role Functioning: Change at Cycle 5 Day 1 Number Analyzed 20 participants 50 participants
5.00  (22.361) -5.33  (26.393)
Role Functioning: Change at Cycle 6 Day 1 Number Analyzed 19 participants 40 participants
6.14  (21.667) -3.33  (16.963)
Role Functioning: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
12.82  (24.677) -7.07  (16.682)
Role Functioning: Change at Cycle 8 Day 1 Number Analyzed 8 participants 33 participants
10.42  (19.796) -4.04  (19.557)
Role Functioning: Change at Cycle 9 Day 1 Number Analyzed 10 participants 29 participants
10.00  (23.831) -9.77  (30.052)
Emotional Functioning: Change at Cycle 2 Day 1 Number Analyzed 43 participants 74 participants
3.17  (19.638) 1.95  (20.483)
Emotional Functioning: Change at Cycle 3 Day 1 Number Analyzed 29 participants 64 participants
1.15  (18.730) 1.56  (18.538)
Emotional Functioning: Change at Cycle 4 Day 1 Number Analyzed 26 participants 54 participants
3.53  (22.007) 1.39  (21.277)
Emotional Functioning: Change at Cycle 5 Day 1 Number Analyzed 20 participants 49 participants
5.83  (24.046) -4.59  (19.622)
Emotional Functioning: Change at Cycle 6 Day 1 Number Analyzed 19 participants 40 participants
7.02  (20.650) 1.04  (19.809)
Emotional Functioning: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
3.85  (18.199) -4.63  (19.576)
Emotional Functioning: Change at Cycle 8 Day 1 Number Analyzed 9 participants 33 participants
20.37  (26.389) 3.11  (19.810)
Emotional Functioning: Change at Cycle 9 Day 1 Number Analyzed 10 participants 29 participants
5.83  (18.023) 2.11  (17.246)
Cognitive Functioning: Change at Cycle 2 Day 1 Number Analyzed 43 participants 74 participants
0.78  (13.586) -2.48  (26.985)
Cognitive Functioning: Change at Cycle 3 Day 1 Number Analyzed 29 participants 64 participants
-1.72  (16.871) -4.17  (23.382)
Cognitive Functioning: Change at Cycle 4 Day 1 Number Analyzed 26 participants 54 participants
-0.64  (15.261) -4.94  (21.385)
Cognitive Functioning: Change at Cycle 5 Day 1 Number Analyzed 20 participants 49 participants
-4.17  (14.178) -6.46  (25.188)
Cognitive Functioning: Change at Cycle 6 Day 1 Number Analyzed 19 participants 40 participants
-0.88  (12.998) -1.25  (19.017)
Cognitive Functioning: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
-2.56  (11.479) -5.56  (18.942)
Cognitive Functioning: Change at Cycle 8 Day 1 Number Analyzed 9 participants 33 participants
-7.41  (12.108) 1.52  (17.362)
Cognitive Functioning: Change at Cycle 9 Day 1 Number Analyzed 10 participants 29 participants
-11.67  (26.117) -2.30  (23.873)
Social Functioning: Change at Cycle 2 Day 1 Number Analyzed 43 participants 74 participants
0.39  (19.412) 4.50  (21.422)
Social Functioning: Change at Cycle 3 Day 1 Number Analyzed 29 participants 64 participants
3.45  (16.891) 0.78  (21.088)
Social Functioning: Change at Cycle 4 Day 1 Number Analyzed 26 participants 54 participants
3.85  (24.179) 1.85  (23.272)
Social Functioning: Change at Cycle 5 Day 1 Number Analyzed 20 participants 49 participants
3.33  (22.685) 0.34  (23.445)
Social Functioning: Change at Cycle 6 Day 1 Number Analyzed 19 participants 40 participants
10.53  (16.860) 0.00  (24.749)
Social Functioning: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
12.82  (22.724) 0.00  (18.162)
Social Functioning: Change at Cycle 8 Day 1 Number Analyzed 9 participants 33 participants
12.96  (16.197) 2.02  (23.848)
Social Functioning: Change at Cycle 9 Day 1 Number Analyzed 10 participants 29 participants
10.00  (14.055) -2.30  (27.359)
Fatigue: Change at Cycle 2 Day 1 Number Analyzed 43 participants 75 participants
5.17  (22.919) 6.44  (24.542)
Fatigue: Change at Cycle 3 Day 1 Number Analyzed 29 participants 65 participants
1.92  (18.322) 6.58  (24.901)
Fatigue: Change at Cycle 4 Day 1 Number Analyzed 26 participants 55 participants
-2.56  (21.154) 7.58  (25.912)
Fatigue: Change at Cycle 5 Day 1 Number Analyzed 20 participants 50 participants
-5.56  (24.048) 9.67  (23.404)
Fatigue: Change at Cycle 6 Day 1 Number Analyzed 19 participants 40 participants
-5.85  (19.376) 7.78  (17.649)
Fatigue: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
-1.71  (19.692) 14.14  (20.838)
Fatigue: Change at Cycle 8 Day 1 Number Analyzed 8 participants 33 participants
-12.50  (22.567) 9.09  (19.534)
Fatigue: Change at Cycle 9 Day 1 Number Analyzed 10 participants 29 participants
-1.11  (16.932) 12.64  (20.080)
Nausea/Vomiting: Change at Cycle 2 Day 1 Number Analyzed 43 participants 75 participants
-0.78  (8.095) 0.22  (12.703)
Nausea/Vomiting: Change at Cycle 3 Day 1 Number Analyzed 29 participants 65 participants
0.00  (13.363) -1.79  (12.884)
Nausea/Vomiting: Change at Cycle 4 Day 1 Number Analyzed 26 participants 55 participants
0.00  (16.330) 0.30  (13.414)
Nausea/Vomiting: Change at Cycle 5 Day 1 Number Analyzed 20 participants 50 participants
0.83  (10.080) 1.00  (13.640)
Nausea/Vomiting: Change at Cycle 6 Day 1 Number Analyzed 19 participants 40 participants
-0.88  (3.824) 1.67  (13.503)
Nausea/Vomiting: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
-1.28  (14.372) 3.03  (13.472)
Nausea/Vomiting: Change at Cycle 8 Day 1 Number Analyzed 8 participants 33 participants
0.00  (0.000) 0.51  (12.832)
Nausea/Vomiting: Change at Cycle 9 Day 1 Number Analyzed 10 participants 29 participants
0.00  (0.000) -2.30  (13.890)
Pain: Change at Cycle 2 Day 1 Number Analyzed 43 participants 75 participants
-2.33  (30.338) -0.22  (26.351)
Pain: Change at Cycle 3 Day 1 Number Analyzed 29 participants 65 participants
-9.77  (22.056) -1.54  (30.151)
Pain: Change at Cycle 4 Day 1 Number Analyzed 26 participants 55 participants
0.00  (29.439) -4.85  (25.795)
Pain: Change at Cycle 5 Day 1 Number Analyzed 20 participants 50 participants
-4.17  (25.291) -4.00  (25.098)
Pain: Change at Cycle 6 Day 1 Number Analyzed 19 participants 40 participants
-14.04  (29.535) -2.92  (24.427)
Pain: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
-21.79  (29.174) -4.04  (24.661)
Pain: Change at Cycle 8 Day 1 Number Analyzed 9 participants 33 participants
-14.81  (28.191) -7.58  (25.716)
Pain: Change at Cycle 9 Day 1 Number Analyzed 10 participants 29 participants
-21.67  (28.382) -5.17  (24.030)
Dyspnoea: Change at Cycle 2 Day 1 Number Analyzed 42 participants 75 participants
2.38  (17.097) 1.33  (24.162)
Dyspnoea: Change at Cycle 3 Day 1 Number Analyzed 28 participants 65 participants
3.57  (16.578) -0.51  (23.930)
Dyspnoea: Change at Cycle 4 Day 1 Number Analyzed 25 participants 55 participants
0.00  (16.667) 2.42  (24.724)
Dyspnoea: Change at Cycle 5 Day 1 Number Analyzed 19 participants 49 participants
3.51  (21.928) 0.00  (28.054)
Dyspnoea: Change at Cycle 6 Day 1 Number Analyzed 18 participants 40 participants
1.85  (13.873) -1.67  (19.900)
Dyspnoea: Change at Cycle 7 Day 1 Number Analyzed 12 participants 33 participants
2.78  (30.011) 2.02  (21.952)
Dyspnoea: Change at Cycle 8 Day 1 Number Analyzed 8 participants 33 participants
8.33  (23.570) 2.02  (21.952)
Dyspnoea: Change at Cycle 9 Day 1 Number Analyzed 9 participants 29 participants
7.41  (27.778) 2.30  (17.663)
Insomnia: Change at Cycle 2 Day 1 Number Analyzed 43 participants 75 participants
-2.33  (26.622) 0.44  (24.195)
Insomnia: Change at Cycle 3 Day 1 Number Analyzed 29 participants 65 participants
-6.90  (24.200) -0.51  (26.016)
Insomnia: Change at Cycle 4 Day 1 Number Analyzed 26 participants 55 participants
-10.26  (29.468) -1.82  (19.687)
Insomnia: Change at Cycle 5 Day 1 Number Analyzed 20 participants 50 participants
-15.00  (31.484) 1.33  (30.087)
Insomnia: Change at Cycle 6 Day 1 Number Analyzed 19 participants 40 participants
-17.54  (32.142) -4.17  (24.093)
Insomnia: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
-7.69  (41.172) 1.01  (28.241)
Insomnia: Change at Cycle 8 Day 1 Number Analyzed 8 participants 33 participants
-25.00  (52.705) 3.03  (25.500)
Insomnia: Change at Cycle 9 Day 1 Number Analyzed 10 participants 29 participants
-6.67  (40.976) 5.75  (25.306)
Appetite loss: Change at Cycle 2 Day 1 Number Analyzed 43 participants 74 participants
4.65  (26.807) -2.25  (27.215)
Appetite loss: Change at Cycle 3 Day 1 Number Analyzed 29 participants 62 participants
-2.30  (15.252) -4.30  (22.163)
Appetite loss: Change at Cycle 4 Day 1 Number Analyzed 26 participants 54 participants
-1.28  (30.523) -3.09  (26.117)
Appetite loss: Change at Cycle 5 Day 1 Number Analyzed 20 participants 49 participants
3.33  (21.357) -1.36  (30.398)
Appetite loss: Change at Cycle 6 Day 1 Number Analyzed 19 participants 39 participants
-1.75  (17.476) -2.56  (29.004)
Appetite loss: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
-5.13  (12.518) -1.01  (30.601)
Appetite loss: Change at Cycle 8 Day 1 Number Analyzed 8 participants 32 participants
-4.17  (11.785) -2.08  (31.609)
Appetite loss: Change at Cycle 9 Day 1 Number Analyzed 10 participants 28 participants
-3.33  (18.922) 1.19  (30.741)
Constipation: Change at Cycle 2 Day 1 Number Analyzed 43 participants 74 participants
1.55  (19.181) 2.25  (21.603)
Constipation: Change at Cycle 3 Day 1 Number Analyzed 29 participants 63 participants
0.00  (21.822) 1.06  (20.712)
Constipation: Change at Cycle 4 Day 1 Number Analyzed 26 participants 54 participants
-2.56  (18.674) 1.23  (21.440)
Constipation: Change at Cycle 5 Day 1 Number Analyzed 20 participants 49 participants
5.00  (16.312) -0.68  (22.037)
Constipation: Change at Cycle 6 Day 1 Number Analyzed 19 participants 40 participants
0.00  (15.713) -1.67  (18.413)
Constipation: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
5.13  (18.490) 4.04  (13.838)
Constipation: Change at Cycle 8 Day 1 Number Analyzed 8 participants 33 participants
8.33  (15.430) -2.02  (16.540)
Constipation: Change at Cycle 9 Day 1 Number Analyzed 10 participants 29 participants
0.00  (15.713) 1.15  (22.683)
Diarrhea: Change at Cycle 2 Day 1 Number Analyzed 43 participants 74 participants
3.88  (14.924) 0.45  (24.360)
Diarrhea: Change at Cycle 3 Day 1 Number Analyzed 29 participants 64 participants
1.15  (14.037) -1.04  (20.547)
Diarrhea: Change at Cycle 4 Day 1 Number Analyzed 26 participants 54 participants
3.85  (23.715) -1.85  (19.870)
Diarrhea: Change at Cycle 5 Day 1 Number Analyzed 20 participants 49 participants
6.67  (20.520) -0.68  (23.064)
Diarrhea: Change at Cycle 6 Day 1 Number Analyzed 19 participants 40 participants
3.51  (18.904) -1.67  (18.413)
Diarrhea: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
0.00  (13.608) 1.01  (19.516)
Diarrhea: Change at Cycle 8 Day 1 Number Analyzed 9 participants 33 participants
3.70  (11.111) -1.01  (19.516)
Diarrhea: Change at Cycle 9 Day 1 Number Analyzed 10 participants 29 participants
3.33  (10.541) -2.30  (21.696)
Financial Problems: Change at Cycle 2 Day 1 Number Analyzed 43 participants 74 participants
-3.10  (17.539) -3.15  (25.385)
Financial Problems: Change at Cycle 3 Day 1 Number Analyzed 28 participants 63 participants
0.00  (18.144) -4.23  (24.313)
Financial Problems: Change at Cycle 4 Day 1 Number Analyzed 26 participants 54 participants
-5.13  (22.494) -4.94  (23.710)
Financial Problems: Change at Cycle 5 Day 1 Number Analyzed 20 participants 49 participants
0.00  (18.732) -6.80  (22.546)
Financial Problems: Change at Cycle 6 Day 1 Number Analyzed 19 participants 40 participants
-1.75  (23.501) -5.83  (27.099)
Financial Problems: Change at Cycle 7 Day 1 Number Analyzed 13 participants 33 participants
-2.56  (21.350) 1.01  (19.516)
Financial Problems: Change at Cycle 8 Day 1 Number Analyzed 9 participants 33 participants
-3.70  (20.031) 1.01  (19.516)
Financial Problems: Change at Cycle 9 Day 1 Number Analyzed 10 participants 29 participants
-10.00  (16.102) -2.30  (23.454)
Global health status/QoL: Change at Cycle 2 Day 1 Number Analyzed 43 participants 72 participants
-3.68  (21.845) 2.55  (15.298)
Global health status/QoL: Change at Cycle 3 Day 1 Number Analyzed 29 participants 62 participants
3.74  (14.362) -2.55  (19.823)
Global health status/QoL: Change at Cycle 4 Day 1 Number Analyzed 26 participants 51 participants
-2.24  (14.636) -0.49  (18.136)
Global health status/QoL: Change at Cycle 5 Day 1 Number Analyzed 20 participants 48 participants
7.50  (14.023) -1.91  (21.210)
Global health status/QoL: Change at Cycle 6 Day 1 Number Analyzed 19 participants 38 participants
10.96  (11.802) 4.17  (19.447)
Global health status/QoL: Change at Cycle 7 Day 1 Number Analyzed 13 participants 32 participants
16.03  (22.428) -3.13  (19.715)
Global health status/QoL: Change at Cycle 8 Day 1 Number Analyzed 9 participants 31 participants
7.41  (14.096) 2.15  (21.727)
Global health status/QoL: Change at Cycle 9 Day 1 Number Analyzed 10 participants 28 participants
6.67  (20.713) -7.14  (28.211)
9.Secondary Outcome
Title Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire
Hide 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])
Hide Outcome Measure Data
Hide 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 Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 42 71
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Emotions: Change at Cycle 2 Day 1 Number Analyzed 42 participants 69 participants
-6.90  (24.422) -8.93  (27.767)
Emotions: Change at Cycle 3 Day 1 Number Analyzed 26 participants 63 participants
-7.92  (18.033) -8.60  (25.641)
Emotions: Change at Cycle 4 Day 1 Number Analyzed 22 participants 51 participants
-3.97  (17.175) -11.45  (24.215)
Emotions: Change at Cycle 5 Day 1 Number Analyzed 17 participants 46 participants
-0.14  (12.835) -10.25  (24.646)
Emotions: Change at Cycle 6 Day 1 Number Analyzed 16 participants 35 participants
-9.08  (22.824) -19.73  (27.304)
Emotions: Change at Cycle 7 Day 1 Number Analyzed 12 participants 30 participants
6.55  (17.053) -13.65  (27.132)
Emotions: Change at Cycle 8 Day 1 Number Analyzed 8 participants 30 participants
2.38  (5.247) -13.97  (25.001)
Emotions: Change at Cycle 9 Day 1 Number Analyzed 10 participants 28 participants
8.17  (12.868) -15.08  (31.843)
Symptoms: Change at Cycle 2 Day 1 Number Analyzed 42 participants 71 participants
0.99  (18.788) -1.31  (21.607)
Symptoms: Change at Cycle 3 Day 1 Number Analyzed 26 participants 64 participants
3.85  (16.580) -0.26  (24.158)
Symptoms: Change at Cycle 4 Day 1 Number Analyzed 22 participants 52 participants
5.30  (18.464) -6.62  (23.917)
Symptoms: Change at Cycle 5 Day 1 Number Analyzed 17 participants 47 participants
-0.98  (15.205) -4.11  (18.062)
Symptoms: Change at Cycle 6 Day 1 Number Analyzed 16 participants 36 participants
-1.56  (16.307) -1.85  (21.419)
Symptoms: Change at Cycle 7 Day 1 Number Analyzed 12 participants 30 participants
4.17  (23.233) 0.69  (24.518)
Symptoms: Change at Cycle 8 Day 1 Number Analyzed 8 participants 31 participants
6.77  (18.222) -2.96  (24.395)
Symptoms: Change at Cycle 9 Day 1 Number Analyzed 10 participants 28 participants
10.42  (21.178) -3.42  (24.455)
Functioning: Change at Cycle 2 Day 1 Number Analyzed 42 participants 71 participants
-3.49  (19.183) -4.98  (23.650)
Functioning: Change at Cycle 3 Day 1 Number Analyzed 26 participants 63 participants
-5.00  (18.166) -4.76  (20.203)
Functioning: Change at Cycle 4 Day 1 Number Analyzed 22 participants 51 participants
-8.18  (24.119) -5.82  (23.275)
Functioning: Change at Cycle 5 Day 1 Number Analyzed 17 participants 47 participants
-7.06  (20.746) -3.76  (16.369)
Functioning: Change at Cycle 6 Day 1 Number Analyzed 16 participants 35 participants
-12.08  (27.022) -11.14  (18.113)
Functioning: Change at Cycle 7 Day 1 Number Analyzed 12 participants 30 participants
-3.89  (19.583) -6.00  (15.767)
Functioning: Change at Cycle 8 Day 1 Number Analyzed 8 participants 30 participants
-8.33  (26.367) -7.00  (17.926)
Functioning: Change at Cycle 9 Day 1 Number Analyzed 10 participants 28 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
Hide 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
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Hide Analysis Population Description
The safety analysis set (SAF) included all enrolled participants who received any study drug for each group.
Arm/Group Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 54 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
Hide 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)
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Hide 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 Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 30 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
Hide 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)
Hide Outcome Measure Data
Hide 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 Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 32 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
Hide 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)
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Hide 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 Title Group 1: Metastatic BCC (mBCC) Group 2: Unresectable Locally Advanced BCC (laBCC)
Hide 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.
Overall Number of Participants Analyzed 52 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
   0.0%
4
   4.9%
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)
Hide 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 (%) Affected / at Risk (%)
Total   16/54 (29.63%)      17/84 (20.24%)    
Hide 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 (38.10%)    
Blood and lymphatic system disorders     
Anaemia  1  0/54 (0.00%)  0 2/84 (2.38%)  3
Pancytopenia  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Lymphadenopathy mediastinal  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Cardiac disorders     
Cardiac failure  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Autoimmune pericarditis  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Myocardial infarction  1  0/54 (0.00%)  0 2/84 (2.38%)  2
Supraventricular tachycardia  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Acute coronary syndrome  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Atrial fibrillation  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Autoimmune myocarditis  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Immune-mediated myocarditis  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Ear and labyrinth disorders     
Ear disorder  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Endocrine disorders     
Adrenal insufficiency  1  0/54 (0.00%)  0 2/84 (2.38%)  2
Hypophysitis  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Gastrointestinal disorders     
Colitis  1  2/54 (3.70%)  2 2/84 (2.38%)  2
Autoimmune colitis  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Constipation  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Erosive oesophagitis  1  0/54 (0.00%)  0 1/84 (1.19%)  1
General disorders     
Pyrexia  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Fatigue  1  0/54 (0.00%)  0 1/84 (1.19%)  1
General physical health deterioration  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Hepatobiliary disorders     
Autoimmune hepatitis  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Immune-mediated hepatitis  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Immune system disorders     
Sarcoidosis  1  0/54 (0.00%)  0 1/84 (1.19%)  2
Infections and infestations     
Urinary tract infection  1  1/54 (1.85%)  1 4/84 (4.76%)  4
Pneumonia  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Infection  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Skin infection  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Clostridium difficile infection  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Hepatitis C  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Influenza  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Lower respiratory tract infection  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Oral candidiasis  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Soft tissue infection  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Subcutaneous abscess  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Wound infection staphylococcal  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Arthritis bacterial  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Atypical pneumonia  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Clostridium difficile colitis  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Pneumonia staphylococcal  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Injury, poisoning and procedural complications     
Radial head dislocation  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Upper limb fracture  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Fall  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Infusion related reaction  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Multiple fractures  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Procedural pain  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Tibia fracture  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Wound haemorrhage  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Investigations     
Weight decreased  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Metabolism and nutrition disorders     
Cachexia  1  0/54 (0.00%)  0 1/84 (1.19%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Dupuytren's contracture  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Infected neoplasm  1  0/54 (0.00%)  0 2/84 (2.38%)  2
Basal cell carcinoma  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Brain neoplasm malignant  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Meningioma  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Lymphoproliferative disorder  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Brain oedema  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Cerebrospinal fluid leakage  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Dizziness  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Haemorrhage intracranial  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Somnolence  1  1/54 (1.85%)  2 1/84 (1.19%)  1
Facial paralysis  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Headache  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Psychiatric disorders     
Delirium  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/54 (0.00%)  0 2/84 (2.38%)  2
Urinary retention  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonitis  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Haemoptysis  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Respiratory failure  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Pulmonary oedema  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Pleural effusion  1  1/54 (1.85%)  1 0/84 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermal cyst  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Vascular disorders     
Hypotension  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Hypertensive crisis  1  0/54 (0.00%)  0 1/84 (1.19%)  2
Peripheral ischaemia  1  0/54 (0.00%)  0 1/84 (1.19%)  1
Phlebitis  1  0/54 (0.00%)  0 1/84 (1.19%)  1
1
Term from vocabulary, MedDRA 23.1
Indicates events were collected by systematic assessment
Hide 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  1  6/54 (11.11%)  7 13/84 (15.48%)  19
Leukocytosis  1  1/54 (1.85%)  1 7/84 (8.33%)  8
Endocrine disorders     
Hypothyroidism  1  4/54 (7.41%)  4 8/84 (9.52%)  9
Hyperthyroidism  1  5/54 (9.26%)  7 2/84 (2.38%)  2
Eye disorders     
Cataract  1  0/54 (0.00%)  0 5/84 (5.95%)  6
Gastrointestinal disorders     
Nausea  1  6/54 (11.11%)  9 13/84 (15.48%)  19
Vomiting  1  7/54 (12.96%)  9 6/84 (7.14%)  10
Constipation  1  12/54 (22.22%)  14 5/84 (5.95%)  6
Diarrhoea  1  20/54 (37.04%)  27 20/84 (23.81%)  33
Abdominal pain  1  4/54 (7.41%)  4 6/84 (7.14%)  7
Dry mouth  1  3/54 (5.56%)  3 3/84 (3.57%)  3
General disorders     
Pyrexia  1  7/54 (12.96%)  9 5/84 (5.95%)  7
Asthenia  1  5/54 (9.26%)  6 17/84 (20.24%)  27
Fatigue  1  23/54 (42.59%)  31 25/84 (29.76%)  34
Oedema peripheral  1  6/54 (11.11%)  8 5/84 (5.95%)  5
Influenza like illness  1  2/54 (3.70%)  2 5/84 (5.95%)  7
Pain  1  3/54 (5.56%)  4 2/84 (2.38%)  2
Infections and infestations     
Urinary tract infection  1  4/54 (7.41%)  5 10/84 (11.90%)  11
Bronchitis  1  0/54 (0.00%)  0 6/84 (7.14%)  7
Upper respiratory tract infection  1  3/54 (5.56%)  3 6/84 (7.14%)  6
Conjunctivitis  1  0/54 (0.00%)  0 5/84 (5.95%)  5
Injury, poisoning and procedural complications     
Fall  1  4/54 (7.41%)  7 5/84 (5.95%)  5
Infusion related reaction  1  3/54 (5.56%)  3 0/84 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  3/54 (5.56%)  3 4/84 (4.76%)  6
Blood creatinine increased  1  4/54 (7.41%)  4 8/84 (9.52%)  9
Weight decreased  1  5/54 (9.26%)  6 7/84 (8.33%)  7
Blood creatine phosphokinase increased  1  4/54 (7.41%)  5 6/84 (7.14%)  8
Weight increased  1  8/54 (14.81%)  12 2/84 (2.38%)  2
Metabolism and nutrition disorders     
Decreased appetite  1  6/54 (11.11%)  6 14/84 (16.67%)  18
Hypoalbuminaemia  1  1/54 (1.85%)  2 5/84 (5.95%)  11
Hypokalaemia  1  4/54 (7.41%)  4 4/84 (4.76%)  6
Hyperglycaemia  1  6/54 (11.11%)  8 2/84 (2.38%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  5/54 (9.26%)  5 5/84 (5.95%)  6
Arthralgia  1  9/54 (16.67%)  10 16/84 (19.05%)  24
Pain in extremity  1  6/54 (11.11%)  10 4/84 (4.76%)  5
Muscle spasms  1  3/54 (5.56%)  3 5/84 (5.95%)  5
Myalgia  1  3/54 (5.56%)  4 3/84 (3.57%)  3
Neck pain  1  4/54 (7.41%)  4 2/84 (2.38%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour haemorrhage  1  1/54 (1.85%)  1 9/84 (10.71%)  12
Basal cell carcinoma  1  3/54 (5.56%)  5 7/84 (8.33%)  8
Seborrhoeic keratosis  1  1/54 (1.85%)  1 5/84 (5.95%)  5
Nervous system disorders     
Headache  1  6/54 (11.11%)  7 12/84 (14.29%)  14
Dizziness  1  5/54 (9.26%)  5 7/84 (8.33%)  8
Psychiatric disorders     
Anxiety  1  3/54 (5.56%)  3 3/84 (3.57%)  3
Renal and urinary disorders     
Haematuria  1  4/54 (7.41%)  5 3/84 (3.57%)  3
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/54 (7.41%)  5 10/84 (11.90%)  14
Dyspnoea  1  4/54 (7.41%)  5 11/84 (13.10%)  17
Skin and subcutaneous tissue disorders     
Rash  1  4/54 (7.41%)  4 6/84 (7.14%)  6
Pruritus  1  8/54 (14.81%)  13 20/84 (23.81%)  24
Dry skin  1  5/54 (9.26%)  6 7/84 (8.33%)  7
Actinic keratosis  1  3/54 (5.56%)  3 6/84 (7.14%)  9
Rash maculo-papular  1  5/54 (9.26%)  6 6/84 (7.14%)  7
Dermatitis  1  0/54 (0.00%)  0 5/84 (5.95%)  6
Eczema  1  5/54 (9.26%)  7 5/84 (5.95%)  5
Vascular disorders     
Hypertension  1  11/54 (20.37%)  29 8/84 (9.52%)  13
1
Term from vocabulary, MedDRA 23.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators 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
Layout table for Results Point of Contact information
Name/Title: Clinical Trials Administrator
Organization: Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
EMail: clinicaltrials@regeneron.com
Layout table for additonal information
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03132636    
Other Study ID Numbers: R2810-ONC-1620
2016-003122-16 ( EudraCT Number )
First Submitted: April 24, 2017
First Posted: April 28, 2017
Results First Submitted: May 17, 2022
Results First Posted: July 26, 2022
Last Update Posted: July 26, 2022