A Phase 3 interventional study of Cemiplimab and Standard of care in Cutaneous Squamous Cell Carcinoma (CSCC), sponsored by Regeneron Pharmaceuticals. Recruiting at 53 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
Among 379 studies in Skin Neoplasms with a site in United States — 62 open to participants now, 96 under way, 7 of them phase 3. Skin Neoplasms · United States.
Among the 379 studies in Skin Neoplasms with a site in United States, this one is the 42nd largest by planned enrollment of the 288 interventional ones that give a count, is one of 20 that started in 2025, is one of 22 in phase 3, reaches primary completion later than 87 of the 94 other live ones, and was the 341st registered.
604 studies on the registry are indexed under Skin Neoplasms; 126 are open to participants now.
Browse Skin Neoplasms studies →62 of the 379 studies in Skin Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Rutgers, The State University of New Jersey · Sites in United States
Ages 13+ · Healthy volunteers
University of Utah · Sites in United States
Ages 18–29 · Healthy volunteers
Marissa Lobl · Sites in United States
Ages 18+
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 104 Skin Neoplasms studies recruiting now, 84 (81%) set no upper age limit and 9 (9%) stop at 75 or younger; 15 take children under 18; 25 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
379 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 114 · Phase 3 26 · Phase 4 11
First in 1977; this study’s year is marked. 20 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 369 is above the median of 55 across 408 interventional studies indexed under Skin Neoplasms.
Median enrollment 44 across the 288 interventional studies, 149 across the 80 observational. Of the 258 that completed or were terminated, 92 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
107 of 379 have an industry lead sponsor. The 10 most frequent:
Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Regeneron Pharmaceuticals has 4 studies filed under Skin Neoplasms — fewer than ten, so there is no comparison to draw.
33 of the studies in Skin Neoplasms with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05608291Phase 3Regeneron PharmaceuticalsA Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | 2027-01-15 |
| NCT06947928Phase 3TuHURA Biosciences, Inc.Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma | 2027-03-31 |
| NCT05634252Phase 3University of UtahUndergraduate Skin Cancer Prevention Trial | 2027-09-04 |
| NCT07201376Dartmouth-Hitchcock Medical CenterAssessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically | 2026-11 |
| NCT06608511University of Wisconsin, MadisonLiquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers | 2026-12 |
Among the 379 studies in Skin Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will test a study drug called cemiplimab to see if it can help treat early-stage Cutaneous Squamous Cell Carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called Programmed cell Death-1 (PD-1) on the surface of certain immune cells.
The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.
The study is looking at:
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion / exclusion criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Cemiplimab
Procedure: Standard of care
Administered per protocol
Also known as: Libtayo
Primary surgery
Event-Free Survival (EFS) as assessed by the investigator
Time frame: Up to 1 year
EFS as assessed by the investigator
Time frame: Up to 3 years
Composite Complete Response (CCR) for Target Lesion (TL)
Experimental Arm
Time frame: At week 13
Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL)
Experimental Arm
Time frame: Baseline and at week 13
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 3 years
Severity of TEAEs
Time frame: Up to 3 years
Size of surgical defect
Time frame: At week 13
Size of biopsy defect
Time frame: At week 13
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
Started Jan 2025 (actual). Primary completion is estimated for May 2030, 64 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Cemiplimab