A Phase 2 interventional study of cemiplimab in Carcinoma, Basal Cell, sponsored by Regeneron Pharmaceuticals. Completed at 71 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment
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
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This study's enrollment of 138 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria apply
Administration of cemiplimab in accordance with protocol dosing regimen
Drug: cemiplimab
Administration of cemiplimab in accordance with protocol dosing regimen
Drug: cemiplimab
Regimen as per protocol
Also known as: REGN2810, Libtayo
Objective Response Rate (ORR) as Assessed by Independent Central Review (ICR)
ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 assessed as per ICR assessment. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm) (\< 1 centimeter \[cm\]). PR: At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. ORR was determined by Clopper-Pearson method.
Time frame: Up to 1422 days (approximately 46 months)
Objective Response Rate (ORR) Per Investigator Assessment
ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 per Investigator 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 (approximately 46 months)
Duration of Response (DOR) as Assessed by ICR
DOR per ICR was determined for participants with best overall response of CR or PR. DOR was measured from the time measurement criteria are first met for CR/PR (whichever was first recorded) until the first date of recurrent or progressive disease (PD) (photographic or radiographic), or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). DOR was determined by Kaplan-Meier estimate.
Time frame: Up to 48 months
Duration of Response (DOR) Per Investigator Assessment
DOR per investigator assessment was determined for participants with best overall response of CR or PR. DOR was measured from the time measurement criteria are first met for CR/PR (whichever was first recorded) until the first date of recurrent or progressive disease (PD) (photographic or radiographic), or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). DOR was determined by Kaplan-Meier estimate.
Time frame: Up to 48 months
Complete Response (CR) Rate as Assessed by ICR
CR rate 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). CR rate 95% confidence interval determined by Clopper-Pearson exact confidence interval.
Time frame: Up to 48 months
Complete Response (CR) Rate Per Investigator Assessment
CR rate 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). CR rate 95% confidence interval determined by Clopper-Pearson exact confidence interval.
Time frame: Up to 48 months
Progression Free Survival (PFS) as Assessed by ICR
PFS was defined as the time from start of treatment until the first date of recurrent or PD (photographic or radiographic), or death due to any cause, whichever occurred first, was determined by IRC. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). PFS was determined by Kaplan-Meier estimate.
Time frame: Up to 60 months
Progression Free Survival (PFS) Per Investigator Assessment
PFS was defined as the time from start of treatment until the first date of recurrent or PD (photographic or radiographic), or death due to any cause, whichever occurred first, was determined by IRC. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). PFS was determined by Kaplan-Meier estimate.
Time frame: Up to 60 months
Overall Survival (OS)
OS was measured as time from the start of treatment until death due to any cause. Participants who did not die were censored at the last date that participant was documented to be alive. OS was calculated based on Kaplan-Meier estimate.
Time frame: Up to 60 months
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall QoL in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the GHS/QoL, which are scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a higher score indicates higher ("better") quality of life/functioning and a positive change from baseline indicates improvement. For the symptom scales/items, a higher score indicates a higher ("worse") level of symptoms/problems, and a negative change from baseline indicates improvement.
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])
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire
Skindex-16 questionnaire contains 16 questions related to quality of life in cancer participants. It consisted of a short 16-item assessment completed by the participant, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional \& functional; their respective scores are expressed in a linear scale from 0 to 100. Symptoms scale score was an average of items 1 to 4 expressed in a linear scale from 0 to 100, Emotions scale score was an average of items 5 to 11 expressed in a linear scale from 0 to 100 and Functioning scale score was an average of items 12 to 16 expressed in a linear scale from 0 to 100. A negative change from baseline indicates an improvement in the participants condition compared to the baseline.
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])
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as AEs that developed or worsened during the on-treatment period and treatment-related AEs that occur during post-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs.
Time frame: Up to 1422 days (approximately 46 months)
Serum Concentration at Pre-infusion (Ctrough)
Ctrough of cemiplimab reported.
Time frame: At pre-infusion on Cycle 1 Day 22 and Cycle 3 Day 1 (Each cycle of 9 weeks)
Serum Concentration at End of Infusion (Cmax)
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)
Number of Participants With Anti-Drug Antibody (ADA) Status
Immunogenicity was characterized by ADA responses \& titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses \< 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, ≥ 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the cemiplimab ADA assay post first dose when baseline results = negative or missing.
Time frame: Cycle 1: Days 1 and 43; Cycles 3 and 5: Day 1 (Each cycle of 9 weeks)
| Milestone | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Started | 54 | 84 |
| Completed treatment | 11 | 28 |
| Completed | 6 | 19 |
| Not completed | 48 | 65 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Death | 4 | 7 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Non compliance with protocol by participant | 1 | 1 |
| Withdrew: Subject decision | 1 | 9 |
| Withdrew: Sponsor decision | 0 | 1 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Progressive disease | 33 | 36 |
| Withdrew: Withdrawal of consent | 2 | 5 |
| Withdrew: Did not re-consent | 1 | 0 |
| Withdrew: Lost insurance coverage | 1 | 0 |
| Withdrew: Related to radiological outcomes | 0 | 1 |
| Withdrew: Unable to come to site for continued visits | 0 | 1 |
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.
| Percentage of Participants | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Objective Response Rate (ORR) as Assessed by Independent Central Review (ICR) | 22.2 (12.0 to 35.6) | 32.1 (22.4 to 43.2) |
ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 per Investigator 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.
| Percentage of Participants | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Objective Response Rate (ORR) Per Investigator Assessment | 25.9 (15.0 to 39.7) | 36.9 (26.6 to 48.1) |
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.
| Months | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Duration of Response (DOR) as Assessed by ICR | NA (9.8 to NA) | NA (15.5 to NA) |
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.
| Months | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Duration of Response (DOR) Per Investigator Assessment | NA (9.8 to NA) | 19.6 (16.7 to NA) |
CR rate 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). CR rate 95% confidence interval determined by Clopper-Pearson exact confidence interval.
| Percentage of Participants | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Complete Response (CR) Rate as Assessed by ICR | 3.7 (0.5 to 12.7) | 8.3 (3.4 to 16.4) |
CR rate 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). CR rate 95% confidence interval determined by Clopper-Pearson exact confidence interval.
| Percentage of Participants | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Complete Response (CR) Rate Per Investigator Assessment | 3.7 (0.5 to 12.7) | 8.3 (3.4 to 16.4) |
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.
| Months | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Progression Free Survival (PFS) as Assessed by ICR | 10.1 (4.2 to 15.9) | 16.5 (8.6 to 21.8) |
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.
| Months | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Progression Free Survival (PFS) Per Investigator Assessment | 6.6 (4.2 to 8.3) | 18.1 (10.4 to 21.3) |
OS was measured as time from the start of treatment until death due to any cause. Participants who did not die were censored at the last date that participant was documented to be alive. OS was calculated based on Kaplan-Meier estimate.
| Months | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Overall Survival (OS) | 49.9 (28.4 to NA) | NA (NA to NA) |
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.
| Score on a Scale | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| 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 | -1.33 ± 12.090 | -3.03 ± 13.549 |
| Physical Functioning: Change at Cycle 9 Day 1 | -2.27 ± 8.765 | -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 | 15.00 ± 25.398 | -4.04 ± 19.557 |
| Role Functioning: Change at Cycle 9 Day 1 | 9.09 ± 22.808 | -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 | 16.67 ± 25.000 | 3.11 ± 19.810 |
| Emotional Functioning: Change at Cycle 9 Day 1 | 5.30 ± 17.189 | 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 | -6.06 ± 11.237 | 1.52 ± 17.362 |
| Cognitive Functioning: Change at Cycle 9 Day 1 | -10.61 ± 25.025 | -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 | 10.61 ± 15.407 | 2.02 ± 23.848 |
| Social Functioning: Change at Cycle 9 Day 1 | 9.09 ± 13.670 | -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 | -7.78 ± 24.595 | 9.09 ± 19.534 |
| Fatigue: Change at Cycle 9 Day 1 | -1.01 ± 16.067 | 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 | -13.64 ± 25.624 | -7.58 ± 25.716 |
| Pain: Change at Cycle 9 Day 1 | -19.70 ± 27.707 | -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 | 16.67 ± 36.004 | 2.02 ± 21.952 |
| Dyspnoea: Change at Cycle 9 Day 1 | 6.67 ± 26.294 | 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 | -13.33 ± 54.885 | 3.03 ± 25.500 |
| Insomnia: Change at Cycle 9 Day 1 | -6.06 ± 38.925 | 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 | -3.33 ± 10.541 | -2.08 ± 31.609 |
| Appetite loss: Change at Cycle 9 Day 1 | -3.03 ± 17.979 | 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 | 13.33 ± 23.307 | -2.02 ± 16.540 |
| Constipation: Change at Cycle 9 Day 1 | 0.00 ± 14.907 | 1.15 ± 22.683 |
| Diarhoea: Change at Cycle 2 Day 1 | 3.88 ± 14.924 | 0.45 ± 24.360 |
| Diarhoea: Change at Cycle 3 Day 1 | 1.15 ± 14.037 | -1.04 ± 20.547 |
| Diarhoea: Change at Cycle 4 Day 1 | 3.85 ± 23.715 | -1.85 ± 19.870 |
| Diarhoea: Change at Cycle 5 Day 1 | 6.67 ± 20.520 | -0.68 ± 23.064 |
| Diarhoea: Change at Cycle 6 Day 1 | 3.51 ± 18.904 | -1.67 ± 18.413 |
| Diarhoea: Change at Cycle 7 Day 1 | 0.00 ± 13.608 | 1.01 ± 19.516 |
| Diarhoea: Change at Cycle 8 Day 1 | 0.00 ± 14.907 | -1.01 ± 19.516 |
| Diarhoea: Change at Cycle 9 Day 1 | 0.00 ± 14.907 | -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 | -3.03 ± 17.979 | 1.01 ± 19.516 |
| Financial Problems: Change at Cycle 9 Day 1 | -6.06 ± 20.101 | -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 | 9.09 ± 13.670 | 2.15 ± 21.727 |
| Global health status/QoL: Change at Cycle 9 Day 1 | 8.33 ± 20.412 | -7.14 ± 28.211 |
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.
| Score on a Scale | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Emotions: Change at Cycle 2 Day 1 | -6.90 ± 24.422 | -8.93 ± 27.767 |
| Emotions: Change at Cycle 3 Day 1 | -7.92 ± 18.033 | -8.60 ± 25.641 |
| Emotions: Change at Cycle 4 Day 1 | -3.97 ± 17.175 | -11.45 ± 24.215 |
| Emotions: Change at Cycle 5 Day 1 | -0.14 ± 12.835 | -10.25 ± 24.646 |
| Emotions: Change at Cycle 6 Day 1 | -9.08 ± 22.824 | -19.73 ± 27.304 |
| Emotions: Change at Cycle 7 Day 1 | 6.55 ± 17.053 | -13.65 ± 27.132 |
| Emotions: Change at Cycle 8 Day 1 | -0.71 ± 8.478 | -13.97 ± 25.001 |
| Emotions: Change at Cycle 9 Day 1 | 5.70 ± 14.711 | -15.08 ± 31.843 |
| Symptoms: Change at Cycle 2 Day 1 | 0.99 ± 18.788 | -1.31 ± 21.607 |
| Symptoms: Change at Cycle 3 Day 1 | 3.85 ± 16.580 | -0.26 ± 24.158 |
| Symptoms: Change at Cycle 4 Day 1 | 5.30 ± 18.464 | -6.62 ± 23.917 |
| Symptoms: Change at Cycle 5 Day 1 | -0.98 ± 15.205 | -4.11 ± 18.062 |
| Symptoms: Change at Cycle 6 Day 1 | -1.56 ± 16.307 | -1.85 ± 21.419 |
| Symptoms: Change at Cycle 7 Day 1 | 4.17 ± 23.233 | 0.69 ± 24.518 |
| Symptoms: Change at Cycle 8 Day 1 | 5.00 ± 17.213 | -2.96 ± 24.395 |
| Symptoms: Change at Cycle 9 Day 1 | 8.33 ± 21.246 | -3.42 ± 24.455 |
| Functioning: Change at Cycle 2 Day 1 | -3.49 ± 19.183 | -4.98 ± 23.650 |
| Functioning: Change at Cycle 3 Day 1 | -5.00 ± 18.166 | -4.76 ± 20.203 |
| Functioning: Change at Cycle 4 Day 1 | -8.18 ± 24.119 | -5.82 ± 23.275 |
| Functioning: Change at Cycle 5 Day 1 | -7.06 ± 20.746 | -3.76 ± 16.369 |
| Functioning: Change at Cycle 6 Day 1 | -12.08 ± 27.022 | -11.14 ± 18.113 |
| Functioning: Change at Cycle 7 Day 1 | -3.89 ± 19.583 | -6.00 ± 15.767 |
| Functioning: Change at Cycle 8 Day 1 | -7.33 ± 23.402 | -7.00 ± 17.926 |
| Functioning: Change at Cycle 9 Day 1 | -9.39 ± 21.072 | -5.60 ± 20.965 |
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.
| Participants | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Participants with any TEAEs | 51 | 83 |
| Participants with any Serious TEAEs | 16 | 31 |
Ctrough of cemiplimab reported.
| Milligram per Liter (mg/L) | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Cycle 1 Day 22 | 28.3 ± 18.4 | 29.8 ± 12.0 |
| Cycle 3 Day 1 | 60.6 ± 28.2 | 68.6 ± 32.8 |
Cmax of cemiplimab was reported.
| mg/L | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Cycle 1 Day 1 | 103 ± 25.2 | 104 ± 45.5 |
| Cycle 3 Day 1 | 160 ± 52.7 | 192 ± 91.6 |
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.
| Participants | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Negative ADA | 50 | 74 |
| Pre-Existing ADA | 2 | 2 |
| Treatment-emergent ADA | 0 | 5 |
Collected over From signature of informed consent until 105 days after last dose of study drug (up to 2129 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: Metastatic BCC (mBCC) | 22/54 (40.7%) | 18/54 (33.3%) | 50/54 (92.6%) |
| Group 2: Unresectable Locally Advanced BCC (laBCC) | 21/84 (25%) | 33/84 (39.3%) | 76/84 (90.5%) |
| Event | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| Urinary tract infectionInfections and infestations | 1/54 | 4/84 |
| ColitisGastrointestinal disorders | 2/54 | 2/84 |
| Atrial fibrillationCardiac disorders | 2/54 | 0/84 |
| AnaemiaBlood and lymphatic system disorders | 0/54 | 2/84 |
| Acute kidney injuryRenal and urinary disorders | 0/54 | 2/84 |
| Myocardial infarctionCardiac disorders | 1/54 | 2/84 |
| Infected neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/54 | 2/84 |
| Adrenal insufficiencyEndocrine disorders | 0/54 | 2/84 |
| PneumoniaInfections and infestations | 1/54 | 0/84 |
| InfectionInfections and infestations | 1/54 | 0/84 |
| Event | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) |
|---|---|---|
| FatigueGeneral disorders | 24/54 | 25/84 |
| DiarrhoeaGastrointestinal disorders | 20/54 | 20/84 |
| PruritusSkin and subcutaneous tissue disorders | 8/54 | 20/84 |
| ConstipationGastrointestinal disorders | 12/54 | 5/84 |
| HypertensionVascular disorders | 12/54 | 9/84 |
| AstheniaGeneral disorders | 5/54 | 17/84 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 9/54 | 16/84 |
| Decreased appetiteMetabolism and nutrition disorders | 6/54 | 14/84 |
| NauseaGastrointestinal disorders | 6/54 | 13/84 |
| AnaemiaBlood and lymphatic system disorders | 6/54 | 13/84 |
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(Years) | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) | Total |
|---|---|---|---|
| Mean | 63.8 ± 11.09 | 69.1 ± 12.84 | 67.0 ± 12.42 |
| Sex: Female, Male(Participants) | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) | Total |
|---|---|---|---|
| Female | 16 | 28 | 44 |
| Male | 38 | 56 | 94 |
| Race/Ethnicity, Customized(Participants) | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) | Total |
|---|---|---|---|
| Race : White | 47 | 57 | 104 |
| Race : Not Reported | 1 | 0 | 1 |
| Race : Missing | 6 | 27 | 33 |
| Race/Ethnicity, Customized(Participants) | Group 1: Metastatic BCC (mBCC) | Group 2: Unresectable Locally Advanced BCC (laBCC) | Total |
|---|---|---|---|
| Ethnicity : Not Hispanic or Latino | 46 | 56 | 102 |
| Ethnicity : Hispanic or Latino | 2 | 1 | 3 |
| Ethnicity : Missing | 6 | 27 | 33 |
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Regeneron Pharmaceuticals