Trial Outcomes & Findings for Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma (NCT NCT04154943)
NCT ID: NCT04154943
Last Updated: 2025-12-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Up to 12 weeks
Results posted on
2025-12-23
Participant Flow
As of the data cutoff (01 Dec 2021), 101 participants were screened for study eligibility. 79 participants were randomized and received at least 1 dose of cemiplimab.
Participant milestones
| Measure |
Cemiplimab 350mg Q3W
Participants received cemiplimab, administered at a dose of 350mg every 3 weeks for up to 4 doses
|
|---|---|
|
Overall Study
STARTED
|
79
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
79
|
Reasons for withdrawal
| Measure |
Cemiplimab 350mg Q3W
Participants received cemiplimab, administered at a dose of 350mg every 3 weeks for up to 4 doses
|
|---|---|
|
Overall Study
Study Ongoing
|
68
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Decision by the Investigator
|
1
|
|
Overall Study
Death
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Cemiplimab 350mg Q3W
n=79 Participants
Participants received cemiplimab, administered at a dose of 350mg every 3 weeks for up to 4 doses
|
|---|---|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 11.3 • n=68 Participants
|
|
Age, Customized
17 years and under
|
0 Participants
n=68 Participants
|
|
Age, Customized
18 to 64 years
|
18 Participants
n=68 Participants
|
|
Age, Customized
65 to 84 years
|
54 Participants
n=68 Participants
|
|
Age, Customized
85 years and over
|
7 Participants
n=68 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=68 Participants
|
|
Race/Ethnicity, Customized
White
|
69 Participants
n=68 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=68 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=68 Participants
|
|
Race/Ethnicity, Customized
Unknown / Not Reported
|
8 Participants
n=68 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
74 Participants
n=68 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Reported
|
5 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksOutcome measures
| Measure |
Cemiplimab 350mg Q3W
n=79 Participants
Participants received cemiplimab, administered at a dose of 350mg every 3 weeks for up to 4 doses
|
|---|---|
|
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review
|
40 Participants
|
SECONDARY outcome
Timeframe: Up to 12 WeeksOutcome measures
| Measure |
Cemiplimab 350mg Q3W
n=79 Participants
Participants received cemiplimab, administered at a dose of 350mg every 3 weeks for up to 4 doses
|
|---|---|
|
Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksOutcome measures
| Measure |
Cemiplimab 350mg Q3W
n=79 Participants
Participants received cemiplimab, administered at a dose of 350mg every 3 weeks for up to 4 doses
|
|---|---|
|
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review
|
42 Participants
|
SECONDARY outcome
Timeframe: Up to 12 WeeksOutcome measures
| Measure |
Cemiplimab 350mg Q3W
n=79 Participants
Participants received cemiplimab, administered at a dose of 350mg every 3 weeks for up to 4 doses
|
|---|---|
|
Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 12 WeeksOutcome measures
| Measure |
Cemiplimab 350mg Q3W
n=79 Participants
Participants received cemiplimab, administered at a dose of 350mg every 3 weeks for up to 4 doses
|
|---|---|
|
Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1
|
68.4 Percentage of Participants
Interval 56.9 to 78.4
|
SECONDARY outcome
Timeframe: Up to 12 WeeksOutcome measures
| Measure |
Cemiplimab 350mg Q3W
n=79 Participants
Participants received cemiplimab, administered at a dose of 350mg every 3 weeks for up to 4 doses
|
|---|---|
|
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
Participants with Planned Mohs Surgery
|
2 Participants
|
|
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
Participants with Actual Mohs Surgery
|
2 Participants
|
|
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
Participants with Planned Non-Mohs Surgery
|
77 Participants
|
|
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
Participants with Actual Non-Mohs Surgery
|
68 Participants
|
SECONDARY outcome
Timeframe: Up to 14 WeeksOutcome measures
| Measure |
Cemiplimab 350mg Q3W
n=79 Participants
Participants received cemiplimab, administered at a dose of 350mg every 3 weeks for up to 4 doses
|
|---|---|
|
Number of Participants With Planned and Actual Post-Surgical Management
Planned radiation therapy after surgery
|
47 Participants
|
|
Number of Participants With Planned and Actual Post-Surgical Management
Actual radiation therapy after surgery
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to 50 MonthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 47 MonthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 50 MonthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 MonthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 MonthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 MonthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 MonthsOutcome measures
Outcome data not reported
Adverse Events
Cemiplimab 350 mg Q3W
Serious events: 15 serious events
Other events: 60 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Cemiplimab 350 mg Q3W
n=79 participants at risk
Participants received cemiplimab, administered at a dose of 350mg every 3 weeks for up to 4 doses
|
|---|---|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Infections and infestations
COVID-19 pneumonia
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Infections and infestations
Cellulitis
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Endocrine disorders
Hypophysitis
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
General disorders
Localised oedema
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Psychiatric disorders
Agitation
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Psychiatric disorders
Confusional state
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Psychiatric disorders
Delusion
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Cardiac disorders
Myocardial infarction
|
2.5%
2/79 • Number of events 2 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Cardiac disorders
Atrial flutter
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Cardiac disorders
Cardiac failure congestive
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Cardiac disorders
Cardiomyopathy
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Gastrointestinal disorders
Colitis
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
1/79 • Number of events 1 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
Other adverse events
| Measure |
Cemiplimab 350 mg Q3W
n=79 participants at risk
Participants received cemiplimab, administered at a dose of 350mg every 3 weeks for up to 4 doses
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
15.2%
12/79 • Number of events 14 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Gastrointestinal disorders
Nausea
|
15.2%
12/79 • Number of events 12 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Gastrointestinal disorders
Constipation
|
12.7%
10/79 • Number of events 13 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.9%
11/79 • Number of events 11 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.1%
8/79 • Number of events 8 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.3%
5/79 • Number of events 5 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.1%
4/79 • Number of events 5 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
General disorders
Fatigue
|
30.4%
24/79 • Number of events 29 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
General disorders
Pyrexia
|
5.1%
4/79 • Number of events 5 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Nervous system disorders
Dizziness
|
7.6%
6/79 • Number of events 6 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Nervous system disorders
Headache
|
6.3%
5/79 • Number of events 6 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Nervous system disorders
Hypoaesthesia
|
5.1%
4/79 • Number of events 4 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Endocrine disorders
Hypothyroidism
|
8.9%
7/79 • Number of events 7 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.9%
7/79 • Number of events 7 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Blood and lymphatic system disorders
Anaemia
|
6.3%
5/79 • Number of events 5 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
5/79 • Number of events 6 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
5.1%
4/79 • Number of events 10 • From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER