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Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

StatusRecruiting
PhasePhase 3
Started2025-01-02
View on ClinicalTrials.gov ↗

Amendment history

2026-08-14
Study Status, Eligibility v24
Eligibility criteria+53 characters
[...] ipants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) prior to biopsy and >0.7 cm to ≤2.0 cm after biopsy, located in either the Head or Neck (HN), hand, or pre-tibia [...]
2026-07-07
Study Status, Contacts/Locations v23
Study sites52 entries, revised
HospitalPenn ofMedicine, thePerelman UniversityCenter ofFor PennsylvaniaAdvanced Medicine
2026-06-29
Study Status, Contacts/Locations v22
Study sites50→52
2026-06-04
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v21
Study sites49→50
Eligibility criteria+23 characters
[...] homa (KA), adenosquamous carcinoma, desmoplastic carcinoma, sarcomatoid carcinoma, basal cell carcinoma, basosquamous. carcinoma, Bowen's disease, or CSCC in situ without an inva [...] ic immunosuppressive treatments, which may suggest risk for Immuneimmune-mediated Adverse Events (imAEs), as described in the protoc [...]
Secondary endpoints6 entries, revised
IncidenceOccurrence of Treatment Emergent Adverse Events (TEAEs)
2026-04-21
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 49 sites
Show 19 earlier versions
2026-04-07
Study Status, Contacts/Locations v19
Study sites48→49
2026-02-24
Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 48 sites
2026-02-03
Study Status, Contacts/Locations v17
Study sites47→48
2026-01-20
Study Status, Contacts/Locations v16
Study sites45→47
2026-01-14
Study Status, Contacts/Locations v15
Study sites41→45
2025-12-17
Study Status, Contacts/Locations v14
Study sites40→41
2025-11-20
Study Status, Contacts/Locations v13
Study sites39→40
2025-11-05
Study Status, Contacts/Locations v12
Study sites30→39
2025-10-27
Study Status, Contacts/Locations v11
Study sites30 entries, revised
UniversityNortheast SkinDermatology Oncologists IncAssociates
2025-10-08
Study Status, Contacts/Locations v10
Study sites29→30
2025-09-04
Study Status, Contacts/Locations v9
Study sites27→29
2025-08-26
Study Status, Contacts/Locations v8
Study sites23→27
2025-08-12
Study Status, Contacts/Locations v7
Study sites20→23
2025-07-18
Study Status, References v6
Re-verified, no change to tracked fields
2025-07-08
Study Status, Contacts/Locations v5
Study sites18→20
2025-06-24
Study Status, Contacts/Locations, References v4
Study sites12→18
2025-05-21
Study Status, Contacts/Locations v3
Study sites5→12
2025-02-24
Study Status, Contacts/Locations v2
Study sites4→5
2025-01-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2029-06-03→2030-05-03
Completion date2029-06-03→2030-05-03
Start dateestimated 2025-01-28→confirmed 2025-01-02
Study sites0→4
2024-09-03
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
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: * The side effects cemiplimab might cause * How well cemiplimab works compared to surgery
Trial Details
NCT Number NCT06585410
Lead Sponsor Regeneron Pharmaceuticals
Conditions Cutaneous Squamous Cell Carcinoma (CSCC)
Enrollment 369 participants
Start Date 2025-01-02
Primary Completion 2030-05-03 (estimated)
Study Completion 2030-05-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-16