Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
NCT03889912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97
Last updated 2026-01-21
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).
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
Conditions
Interventions
- DRUG
-
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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-11
- Primary Completion
- 2025-11-13
- Completion
- 2025-12-10
- FDA Drug
- Yes
Countries
- United States
- Australia
- Netherlands
Study Locations
More Related Trials
-
Expanded Access Protocol for Cemiplimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
NCT03492489 ·Status: NO_LONGER_AVAILABLE
-
Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC
NCT04242173 ·Status: TERMINATED ·Phase: PHASE2
-
Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
NCT02760498 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
NCT03969004 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
NCT06190951 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma
NCT04975152 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
NCT04050436 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
CemiplimAb Survivorship Epidemiology
NCT03836105 ·Status: COMPLETED
-
Real World Study on the Use of Cemiplimab in Adult Patients in UK
NCT05493826 ·Status: COMPLETED
-
A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer
NCT05574101 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment
NCT06848088 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2
-
Comparative Efficacy of Cemiplimab to Historical Standard of Care in France
NCT05302297 ·Status: COMPLETED
-
A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer
NCT04315701 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma
NCT06594991 ·Status: RECRUITING ·Phase: PHASE2
-
Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
NCT05352672 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer
NCT04428671 ·Status: RECRUITING ·Phase: PHASE1
-
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
NCT06246916 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment
NCT04526899 ·Status: COMPLETED ·Phase: PHASE2
-
A 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
NCT05608291 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Next-gen Flow Cytometry to Find Immune Profiles, Treatment Response, and Toxicity Markers in Skin Cancer Patients Treated With Cemiplimab.
NCT07064330 ·Status: RECRUITING
-
PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
NCT03132636 ·Status: COMPLETED ·Phase: PHASE2
-
Cemiplimab Plus Imiquimod and Laser Therapy As Neoadjuvant Treatment In Cutaneous Basal Cell Carcinoma
NCT07251413 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Deep sequencIng in Cutaneous Squamous CEll caRciNomas
NCT05878288 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Cemiplimab/Peg-Interferon-α in Advanced CSCC
NCT05729139 ·Status: WITHDRAWN ·Phase: PHASE1
-
Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC
NCT03291002 ·Status: UNKNOWN ·Phase: PHASE1