Cutaneous Squamous Cell CarcinomaPhase 1NCT03889912
Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
A Phase 1 study testing Cemiplimab in people with Cutaneous Squamous Cell Carcinoma and Basal Cell Carcinoma, run by Regeneron Pharmaceuticals at 18 sites in 3 countries.
Trial summary
This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC). The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma, Basal 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
- 97 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 11 Apr 2019to 10 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Dose Escalation: History of recurrent resectable CSCC or BCC (Cohort C and I only) that satisfies conditions as defined in the protocol
- Patients must have measurable disease in the index lesion, defined as 1-2 cm in the longest diameter
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Who cannot join
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs)
- Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.
- Prior treatment with other systemic immune modulating agent as defined in the protocol
- M1 or N1, N2 (a, b, or c), or N3 CSCC or BCC. Patients with history of metastatic CSCC (distant or nodal), or metastatic BCC (distant or nodal) are excluded unless the disease-free interval is at least 3 years
- Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded.
- Patients with a history of solid organ transplant
- Has received a Coronavirus induced disease of 2019 (COVID-19) vaccination (initial series and booster) within 1 week of planned start of study medication
- Note: Other protocol defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States9 sites
MetroDerm
Atlanta, Georgia, 30342
Northeast Dermatology Associates
Beverly, Massachusetts, 01915
Dermatology Associates of the Palm Beaches
Delray Beach, Florida, 33445
Duke Cancer Center
Durham, North Carolina, 27710
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Medical Dermatology Specialists
Phoenix, Arizona, 85006
TCR Medical Corporation
San Diego, California, 92123
Rochester Dermatologic Surgery, P.C.
Victor, New York, 14564
Netherlands5 sites
The Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, North Holland, 1066 CX
University of Groningen, University Medical Centre Groningen
Groningen, 9700 RB
Maastricht University Medical Center
Maastricht, Limburg, 6202 AZ
Radboud University Medical Center
Nijmegen, Gelderland, 6500 HB
Erasmus MC
Rotterdam, 3015 GD
Australia4 sites
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Fremantle Dermatology
Fremantle, Western Australia, 6160
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Alfred Health
Melbourne, Victoria, 3004
About this study
Official title: A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)
This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC).
The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810).
The first part of the study tested several different doses of cemiplimab given weekly for 12 weeks.
The study is also looking at several other research questions, including:
- What side effects may happen from taking the study drug
- To see effect of cemiplimab on the tumor
- How much study drug is in the blood at different times
- Being tested
- Cemiplimab
- Keywords
- CSCC, BCC
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called REGN2810, Libtayo
Each patient will receive intralesional injections of cemiplimab every week (QW), or at less frequent dosing into the lesion at the assigned dose level for 3-12 weeks prior to scheduled surgery
| Study group | Role | What they receive |
|---|---|---|
| Cemiplimab | Experimental | Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion. After completion of the above, three additional cohorts (A, B and C) of patients will be evaluated. Cohorts D, H and I may open after completion of Cohort B.
Note: Cohort E through G will not be opened for participation. Receives: Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Dose levels 1-3
Measured: From the first dose through day 28
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Dose levels 1-3
Measured: From the first dose to 90 days after the last dose
Incidence and severity of TEAEs graded according to the NCI CTCAE v5
Measured: From the first dose up to 90 days after the last dose
The incidence and severity of injection site reactions (ISRs)
Measured: From the first dose to 90 days after the last dose
Secondary outcomes (6)
Objective response rate (ORR) of index lesion
Determined by the investigator using the modified World Health Organization (WHO) criteria
Measured: At baseline and at Week 13
Pathologic complete response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion
Measured: At time of surgery
Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion
Measured: At time of surgery
Cemiplimab concentration in serum over time
Measured: From the first dose up to 90 days after the last dose
Incidence of anti-drug antibody (ADA) titers for cemiplimab
Measured: Up to 90 days after last dose
Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations
The determination of the phase 2 recommended dose will be based primarily on clinical safety observations, according to the dose escalation scheme.
Measured: Up to 90 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start11 Apr 2019
- Primary completion13 Nov 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohorts A, B, D and H will enroll sequentially (not randomized). Cohort C and I for BCC will enroll in parallel with, and independently of, Cohorts A, B, D and H for CSCC patients
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889912
- Sponsor's protocol ID
- R2810-ONC-1787
- Other IDs
- 2024-511440-76-00
- Status last verified
- Jan 2026
- First submitted
- 6 Mar 2019
- Last updated
- 21 Jan 2026
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)
- ClinicalTrials.gov ID
- NCT03889912
- Acronym / sponsor ID
- R2810-ONC-1787
- Keywords
- CSCC, BCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC).
The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810).
The first part of the study tested several different doses of cemiplimab given weekly for 12 weeks.
The study is also looking at several other research questions, including:
- What side effects may happen from taking the study drug
- To see effect of cemiplimab on the tumor
- How much study drug is in the blood at different times
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohorts A, B, D and H will enroll sequentially (not randomized). Cohort C and I for BCC will enroll in parallel with, and independently of, Cohorts A, B, D and H for CSCC patients
| Arm | Type | Receives |
|---|---|---|
| Cemiplimab | Experimental | Drug: CemiplimabThree dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion. After completion of the above, three additional cohorts (A, B and C) of patients will be evaluated. Cohorts D, H and I may open after completion of Cohort B. Note: Cohort E through G will not be opened for participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dose Escalation: History of recurrent resectable CSCC or BCC (Cohort C and I only) that satisfies conditions as defined in the protocol
- Patients must have measurable disease in the index lesion, defined as 1-2 cm in the longest diameter
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Key exclusion criteria (8 listed)
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs)
- Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.
- Prior treatment with other systemic immune modulating agent as defined in the protocol
- M1 or N1, N2 (a, b, or c), or N3 CSCC or BCC. Patients with history of metastatic CSCC (distant or nodal), or metastatic BCC (distant or nodal) are excluded unless the disease-free interval is at least 3 years
- Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded.
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, LibtayoEach patient will receive intralesional injections of cemiplimab every week (QW), or at less frequent dosing into the lesion at the assigned dose level for 3-12 weeks prior to scheduled surgery | Drug | Cemiplimab |
Primary outcome
Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Time frame: From the first dose through day 28
Dose levels 1-3
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Time frame: From the first dose to 90 days after the last dose
Dose levels 1-3
Incidence and severity of TEAEs graded according to the NCI CTCAE v5
Time frame: From the first dose up to 90 days after the last dose
The incidence and severity of injection site reactions (ISRs)
Time frame: From the first dose to 90 days after the last dose
6 secondary outcomes
Objective response rate (ORR) of index lesion
Time frame: At baseline and at Week 13
Pathologic complete response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion
Time frame: At time of surgery
Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion
Time frame: At time of surgery
Cemiplimab concentration in serum over time
Time frame: From the first dose up to 90 days after the last dose
Incidence of anti-drug antibody (ADA) titers for cemiplimab
Time frame: Up to 90 days after last dose
Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations
Time frame: Up to 90 days after last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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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
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cemiplimab in people with Cutaneous Squamous Cell Carcinoma and Basal Cell Carcinoma, run by Regeneron Pharmaceuticals at 18 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 3 inclusion and 8 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Netherlands, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 (time frame: From the first dose through day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.