Trial · NCT04154943
Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
NCT04154943, Phase 2, Completed, Regeneron Pharmaceuticals; results first posted 2023-02-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma. Trials, record NCT04154943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04154943
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
- NCT number
- NCT04154943
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 79 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Interventions
- Cemiplimab
- First posted
- 2019-11-07
- Last updated
- 2025-12-23
- Other registries' IDs
- eudract:2019-003007-35
- Results first posted
- 2023-02-08
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review | Up to 12 weeks | |
| Secondary | Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review | Up to 12 Weeks | |
| Secondary | Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review | Up to 12 weeks | |
| Secondary | Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review | Up to 12 Weeks | |
| Secondary | Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1 | Up to 12 Weeks | |
| Secondary | Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab | Up to 12 Weeks | |
| Secondary | Number of Participants With Planned and Actual Post-Surgical Management | Up to 14 Weeks | |
| Secondary | Event Free Survival (EFS) | Up to 50 Months | |
| Secondary | Disease Free Survival (DFS) | Up to 47 Months | |
| Secondary | Overall Survival (OS) | Up to 50 Months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review | Up to 12 Weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review | Up to 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review | Up to 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review | Up to 12 Weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1 | Up to 12 Weeks | Percentage of Participants | NUMBER | |
| SECONDARY | Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab | Up to 12 Weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Planned and Actual Post-Surgical Management | Up to 14 Weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Event Free Survival (EFS) | Up to 50 Months | |||
| SECONDARY | Disease Free Survival (DFS) | Up to 47 Months | |||
| SECONDARY | Overall Survival (OS) | Up to 50 Months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review | Cemiplimab 350mg Q3W | 10 | Participants | ||
| Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review | Cemiplimab 350mg Q3W | 40 | Participants | ||
| Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review | Cemiplimab 350mg Q3W | 42 | Participants | ||
| Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review | Cemiplimab 350mg Q3W | 10 | Participants | ||
| Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1 | Cemiplimab 350mg Q3W | 68.4 | 95% Confidence Interval 56.9 to 78.4 | Percentage of Participants | |
| Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab | Cemiplimab 350mg Q3W | Participants with Planned Mohs Surgery | 2 | Participants | |
| Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab | Cemiplimab 350mg Q3W | Participants with Actual Mohs Surgery | 2 | Participants | |
| Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab | Cemiplimab 350mg Q3W | Participants with Planned Non-Mohs Surgery | 77 | Participants | |
| Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab | Cemiplimab 350mg Q3W | Participants with Actual Non-Mohs Surgery | 68 | Participants | |
| Number of Participants With Planned and Actual Post-Surgical Management | Cemiplimab 350mg Q3W | Planned radiation therapy after surgery | 47 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cemiplimab 350mg Q3W | 79 | |
| Overall Study | COMPLETED | Cemiplimab 350mg Q3W | 0 | |
| Overall Study | NOT COMPLETED | Cemiplimab 350mg Q3W | 79 |
Source ClinicalTrials.gov
Adverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Cemiplimab 350 mg Q3W | 12 | 79 | 14 |
| other | Nausea | Gastrointestinal disorders | Cemiplimab 350 mg Q3W | 12 | 79 | 12 |
| other | Constipation | Gastrointestinal disorders | Cemiplimab 350 mg Q3W | 10 | 79 | 13 |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Cemiplimab 350 mg Q3W | 11 | 79 | 11 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Cemiplimab 350 mg Q3W | 8 | 79 | 8 |
| other | Rash | Skin and subcutaneous tissue disorders | Cemiplimab 350 mg Q3W | 5 | 79 | 5 |
| other | Dermatitis | Skin and subcutaneous tissue disorders | Cemiplimab 350 mg Q3W | 4 | 79 | 5 |
| other | Fatigue | General disorders | Cemiplimab 350 mg Q3W | 24 | 79 | 29 |
| other | Pyrexia | General disorders | Cemiplimab 350 mg Q3W | 4 | 79 | 5 |
| other | Dizziness | Nervous system disorders | Cemiplimab 350 mg Q3W | 6 | 79 | 6 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cemiplimab 350 mg Q3W | 6 | 79 |
| Total, other adverse events | Cemiplimab 350 mg Q3W | 60 | 79 |
| Total, serious adverse events | Cemiplimab 350 mg Q3W | 15 | 79 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04154943
GET https://conductscience.org/api/trials/v1/NCT04154943/events?page=2