Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review
Secondary
· Up to 12 Weeks
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab 350mg Q3W | 10 |
Last reviewed · How we verify
NCT04154943
Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
Completed
Phase 2
Results posted
Last updated 23 December 2025
What this trial tests
Phase 2 trial testing Cemiplimab in Cutaneous Squamous Cell Carcinoma in 79 participants. Completed in 19 November 2025.
Timeline
10 March 2020
Primary endpoint
1 December 2021
1 December 2021
19 November 2025
Quick facts
| Lead sponsor | Regeneron Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 79 |
| Start date | 10 March 2020 |
| Primary completion | 1 December 2021 |
| Estimated completion | 19 November 2025 |
| Sites | 22 locations across Germany, United States, Australia |
Drugs / interventions tested
- Cemiplimab (CEMIPLIMAB) — full drug profile →
Conditions studied
- Cutaneous Squamous Cell Carcinoma — all drugs for Cutaneous Squamous Cell Carcinoma →
Sponsor
Regeneron Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Cutaneous Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review
Primary
· Up to 12 weeks
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab 350mg Q3W | 40 |
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review
Secondary
· Up to 12 weeks
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab 350mg Q3W | 42 |
Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review
Secondary
· Up to 12 Weeks
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab 350mg Q3W | 10 |
Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1
Secondary
· Up to 12 Weeks
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab 350mg Q3W | 68.4 | 56.9 – 78.4 |
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
Secondary
· Up to 12 Weeks
Participants with Planned Mohs Surgery
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab 350mg Q3W | 2 |
Participants with Actual Mohs Surgery
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab 350mg Q3W | 2 |
Participants with Planned Non-Mohs Surgery
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab 350mg Q3W | 77 |
Participants with Actual Non-Mohs Surgery
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab 350mg Q3W | 68 |
Number of Participants With Planned and Actual Post-Surgical Management
Secondary
· Up to 14 Weeks
Planned radiation therapy after surgery
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab 350mg Q3W | 47 |
Actual radiation therapy after surgery
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab 350mg Q3W | 17 |
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose to the end of treatment period (Week 25) up to 01-DEC-2021 Data cut-off. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cemiplimab 350 mg Q3W
Serious: 15/79 (19%)
Deaths: 6/79
Serious adverse events (21 terms)
| Reaction | System | Cemiplimab 350 mg Q3W |
|---|---|---|
| Myocardial infarction | Cardiac disorders | — |
| Acute myocardial infarction | Cardiac disorders | — |
| Atrial flutter | Cardiac disorders | — |
| Cardiac failure congestive | Cardiac disorders | — |
| Cardiomyopathy | Cardiac disorders | — |
| Colitis | Gastrointestinal disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Cholelithiasis | Hepatobiliary disorders | — |
| Immune-mediated hepatitis | Hepatobiliary disorders | — |
| COVID-19 pneumonia | Infections and infestations | — |
| Cellulitis | Infections and infestations | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Hypophysitis | Endocrine disorders | — |
| Localised oedema | General disorders | — |
| Procedural haemorrhage | Injury, poisoning and procedural complications | — |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Agitation | Psychiatric disorders | — |
| Confusional state | Psychiatric disorders | — |
| Delusion | Psychiatric disorders | — |
| Insomnia | Psychiatric disorders | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — |
Other adverse events (17 terms — click to expand)
| Reaction | System | Cemiplimab 350 mg Q3W |
|---|---|---|
| Fatigue | General disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Hypothyroidism | Endocrine disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Headache | Nervous system disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Dermatitis | Skin and subcutaneous tissue disorders | — |
| Pyrexia | General disorders | — |
| Hypoaesthesia | Nervous system disorders | — |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
Most-reported serious reactions: Myocardial infarction, Acute myocardial infarction, Atrial flutter, Cardiac failure congestive, Cardiomyopathy, Colitis, Dysphagia, Cholelithiasis.
Data from ClinicalTrials.gov NCT04154943 adverse events section.
Sponsor's own description
The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response (pCR) rate per independent central pathology review. The secondary objectives of the study are: * To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including: * Major pathologic response (mPR) rate per independent central pathology review * pCR rate and mPR rate per local pathology review * ORR prior to surgery, according to local assessment using RECIST 1.1 * To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS) * To evaluate the safety profile of neoadjuvant cemiplimab * To assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review * To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma.
Gross ND, Miller DM, Khushalani NI, Divi V, et al · · 2022 · cited 230× · PMID 36094839 · DOI 10.1056/nejmoa2209813 -
The Use of Immune Checkpoint Inhibitors in Oncology and the Occurrence of AKI: Where Do We Stand?
Franzin R, Netti GS, Spadaccino F, Porta C, et al · · 2020 · cited 142× · PMID 33162990 · DOI 10.3389/fimmu.2020.574271 -
Cutaneous Squamous Cell Carcinoma: From Biology to Therapy.
Corchado-Cobos R, García-Sancha N, González-Sarmiento R, Pérez-Losada J, et al · · 2020 · cited 133× · PMID 32331425 · DOI 10.3390/ijms21082956 -
Pilot Phase II Trial of Neoadjuvant Immunotherapy in Locoregionally Advanced, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck.
Ferrarotto R, Amit M, Nagarajan P, Rubin ML, et al · · 2021 · cited 103× · PMID 34187851 · DOI 10.1158/1078-0432.ccr-21-0585 -
Tumor-infiltrating CD8<sup>+</sup> T cell antitumor efficacy and exhaustion: molecular insights.
Kumar S, Singh SK, Rana B, Rana A. · · 2021 · cited 57× · PMID 33450394 · DOI 10.1016/j.drudis.2021.01.002 -
Neoadjuvant cemiplimab and surgery for stage II-IV cutaneous squamous-cell carcinoma: follow-up and survival outcomes of a single-arm, multicentre, phase 2 study.
Gross ND, Miller DM, Khushalani NI, Divi V, et al · · 2023 · cited 51× · PMID 37875144 · DOI 10.1016/s1470-2045(23)00459-x -
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of nonmelanoma skin cancer.
Silk AW, Barker CA, Bhatia S, Bollin KB, et al · · 2022 · cited 28× · PMID 35902131 · DOI 10.1136/jitc-2021-004434 -
Immunotherapy for the Treatment of Cutaneous Squamous Cell Carcinoma.
Boutros A, Cecchi F, Tanda ET, Croce E, et al · · 2021 · cited 28× · PMID 34513710 · DOI 10.3389/fonc.2021.733917
Verify or expand the search:
- PubMed search for NCT04154943
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04154943 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Regeneron Pharmaceuticals
- Last refreshed: 23 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04154943.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing