Cutaneous Squamous Cell CarcinomaPhase 2NCT04154943
Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
A Phase 2 study testing Cemiplimab in people with Cutaneous Squamous Cell Carcinoma, run by Regeneron Pharmaceuticals at 22 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 10 Mar 2020to 19 Nov 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
- At least 1 lesion that is measurable by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ, bone marrow function, and hepatic function as defined in the protocol
Who cannot join
- Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time
- Distant metastatic disease (M1), visceral and/or distant nodal
- Prior radiation therapy for CSCC
- Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
- Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
Show all 9Show fewer
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
- Active tuberculosis
- NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United States15 sites
Regeneron Study Site
Ann Arbor, Michigan, 48109
Regeneron Study Site
Baltimore, Maryland, 21231
Regeneron Study Site
Boston, Massachusetts, 02114
Regeneron Study Site
Boston, Massachusetts, 02215
Regeneron Study Site
Charlotte, North Carolina, 28204
Regeneron Study Site
Cleveland, Ohio, 44195
Regeneron Study Site
Dallas, Texas, 75390
Regeneron Study Site
Durham, North Carolina, 27710
Regeneron Study Site
Houston, Texas, 77030
Regeneron Study Site
Miami, Florida, 33176
Regeneron Study Site
New York, New York, 10065
Regeneron Study Site
Omaha, Nebraska, 68114
Regeneron Study Site
Palo Alto, California, 94304
Regeneron Study Site
Tampa, Florida, 33612
Regeneron Study Site
Washington D.C., District of Columbia, 20037
Germany4 sites
Regeneron Study Site
Dresden, 01307
Regeneron Study Site
Essen, 45147
Regeneron Study Site
Kiel, 24105
Regeneron Study Site
Tübingen, 72076
Australia3 sites
Regeneron Study Site
Herston, Queensland, 4029
Regeneron Study Site
Melbourne, Victoria, 3000
Regeneron Study Site
St Leonards, New South Wales, 2065
About this study
Official title: A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
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
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- Cemiplimab
- Keywords
- CSCC, Stage II, Stage III, Stage IV, CSCC of Head/neck, CSCC of Extremity, CSCC of Trunk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called REGN2810, Libtayo
Intravenous (IV) infusion every 3 weeks (Q3W)
| Study group | Role | What they receive |
|---|---|---|
| Cemiplimab | Experimental | Will receive IV infusion Q3W Receives: Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review
Measured: Up to 12 weeks
Secondary outcomes (13)
Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review
Measured: Up to 12 Weeks
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review
Measured: Up to 12 weeks
Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review
Measured: Up to 12 Weeks
Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1
Measured: Up to 12 Weeks
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
Measured: Up to 12 Weeks
Number of Participants With Planned and Actual Post-Surgical Management
Measured: Up to 14 Weeks
Event Free Survival (EFS)
Measured: Up to 50 Months
Disease Free Survival (DFS)
Measured: Up to 47 Months
Overall Survival (OS)
Measured: Up to 50 Months
Incidence of Adverse Events (AEs)
Measured: Up to 52 Months
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 52 Months
Incidence of Deaths
Measured: Up to 52 Months
Incidence of Laboratory Abnormalities
Measured: Up to 52 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start10 Mar 2020
- Primary completion1 Dec 2021
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154943
- Sponsor's protocol ID
- R2810-ONC-1901
- Other IDs
- 2019-003007-35, 2022-500811-37-00, 2019
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2019
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Publications
Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, Meier F, Su YB, Swiecicki PL, Atlas J, Geiger JL, Hauschild A, Choe JH, Hughes BGM, Lim AM, Ferrarotto R, Wang B, Tao W, Brennan L, Yoo SY, Seebach F, Lowy I, Mathias M, Han H, Fury MG, Rischin D. Phase II Study of Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous Cell Carcinoma: Final Analysis. J Clin Oncol. 2026 Oct 24:JCO2602166. doi: 10.1200/JCO-26-02166. Online ahead of print.
PubMed 42921711Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, Meier F, Su YB, Swiecicki PL, Atlas J, Geiger JL, Hauschild A, Choe JH, Hughes BGM, Schadendorf D, Patel VA, Homsi J, Taube JM, Lim AM, Ferrarotto R, Yoo SY, Mathias M, Han H, Seebach F, Lowy I, Fury MG, Rischin D. 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. Lancet Oncol. 2023 Nov;24(11):1196-1205. doi: 10.1016/S1470-2045(23)00459-X. Epub 2023 Oct 21.
PubMed 37875144Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, Meier F, Su YB, Swiecicki PL, Atlas J, Geiger JL, Hauschild A, Choe JH, Hughes BGM, Schadendorf D, Patel VA, Homsi J, Taube JM, Lim AM, Ferrarotto R, Kaufman HL, Seebach F, Lowy I, Yoo SY, Mathias M, Fenech K, Han H, Fury MG, Rischin D. Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2022 Oct 27;387(17):1557-1568. doi: 10.1056/NEJMoa2209813. Epub 2022 Sep 12.
PubMed 36094839
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
- ClinicalTrials.gov ID
- NCT04154943
- Acronym / sponsor ID
- R2810-ONC-1901
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Keywords
- CSCC, Stage II, Stage III, Stage IV, CSCC of Head/neck, CSCC of Extremity, CSCC of Trunk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cemiplimab | Experimental | Drug: CemiplimabWill receive IV infusion Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
- At least 1 lesion that is measurable by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ, bone marrow function, and hepatic function as defined in the protocol
Key exclusion criteria (9 listed)
- Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time
- Distant metastatic disease (M1), visceral and/or distant nodal
- Prior radiation therapy for CSCC
- Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
- Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: REGN2810, LibtayoIntravenous (IV) infusion every 3 weeks (Q3W) | Drug | Cemiplimab |
Primary outcome
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review
Time frame: Up to 12 weeks
13 secondary outcomes
Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review
Time frame: Up to 12 Weeks
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review
Time frame: Up to 12 weeks
Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review
Time frame: Up to 12 Weeks
Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1
Time frame: Up to 12 Weeks
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
Time frame: Up to 12 Weeks
Number of Participants With Planned and Actual Post-Surgical Management
Time frame: Up to 14 Weeks
Event Free Survival (EFS)
Time frame: Up to 50 Months
Disease Free Survival (DFS)
Time frame: Up to 47 Months
Overall Survival (OS)
Time frame: Up to 50 Months
Incidence of Adverse Events (AEs)
Time frame: Up to 52 Months
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 52 Months
Incidence of Deaths
Time frame: Up to 52 Months
Incidence of Laboratory Abnormalities
Time frame: Up to 52 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42921711Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, Meier F, Su YB, Swiecicki PL, Atlas J, Geiger JL, Hauschild A, Choe JH, Hughes BGM, Lim AM, Ferrarotto R, Wang B, Tao W, Brennan L, Yoo SY, Seebach F, Lowy I, Mathias M, Han H, Fury MG, Rischin D. Phase II Study of Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous Cell Carcinoma: Final Analysis. J Clin Oncol. 2026 Oct 24:JCO2602166. doi: 10.1200/JCO-26-02166. Online ahead of print.
- Derived from this study: PubMed 37875144Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, Meier F, Su YB, Swiecicki PL, Atlas J, Geiger JL, Hauschild A, Choe JH, Hughes BGM, Schadendorf D, Patel VA, Homsi J, Taube JM, Lim AM, Ferrarotto R, Yoo SY, Mathias M, Han H, Seebach F, Lowy I, Fury MG, Rischin D. 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. Lancet Oncol. 2023 Nov;24(11):1196-1205. doi: 10.1016/S1470-2045(23)00459-X. Epub 2023 Oct 21.
- Derived from this study: PubMed 36094839Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, Meier F, Su YB, Swiecicki PL, Atlas J, Geiger JL, Hauschild A, Choe JH, Hughes BGM, Schadendorf D, Patel VA, Homsi J, Taube JM, Lim AM, Ferrarotto R, Kaufman HL, Seebach F, Lowy I, Yoo SY, Mathias M, Fenech K, Han H, Fury MG, Rischin D. Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2022 Oct 27;387(17):1557-1568. doi: 10.1056/NEJMoa2209813. Epub 2022 Sep 12.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Related trials for Cutaneous Squamous Cell Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 2
Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
Locally Recurrent Skin Squamous Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab in people with Cutaneous Squamous Cell Carcinoma, run by Regeneron Pharmaceuticals at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Germany, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154943, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.