Using cemiplimab to treat skin cancers
A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)
PHASE1 · Regeneron Pharmaceuticals · NCT03889912
This study is testing a new drug called cemiplimab to see if it can safely help adults with certain types of skin cancer feel better and manage their tumors.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 113 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals (industry) |
| Drugs / interventions | cemiplimab |
| Locations | 22 sites (Phoenix, Arizona and 21 other locations) |
| Trial ID | NCT03889912 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of an experimental drug called cemiplimab in adult patients with cutaneous squamous cell carcinoma (CSCC) or basal cell carcinoma (BCC). Participants will receive different doses of cemiplimab weekly for 12 weeks, and the study will assess side effects, the drug's effect on tumors, and how the drug is processed in the body. The goal is to determine how well cemiplimab can help manage these skin cancers.
Who should consider this trial
Good fit: Ideal candidates are adults with a history of recurrent, resectable CSCC or BCC who have measurable disease.
Not a fit: Patients with significant autoimmune diseases requiring systemic immunosuppressive treatments or those with metastatic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent skin cancers.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria 1. Dose Escalation: History of recurrent resectable CSCC or BCC (Cohort C and I only) that satisfies conditions as defined in the protocol 2. Patients must have measurable disease in the index lesion, defined as 1-2 cm in the longest diameter 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Key Exclusion Criteria 1. 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) 2. Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway. 3. Prior treatment with other systemic immune modulating agent as defined in the protocol 4. 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 5. Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded. 6. Patients with a history of solid organ transplant 7. 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.
Where this trial is running
Phoenix, Arizona and 21 other locations
- Medical Dermatology Specialists — Phoenix, Arizona, United States (RECRUITING)
- Stanford University School of Medicine — Redwood City, California, United States (WITHDRAWN)
- TCR Medical Corporation — San Diego, California, United States (RECRUITING)
- Dermatology Associates of the Palm Beaches — Delray Beach, Florida, United States (RECRUITING)
- MCC - Magnolia Drive, SRB-3 — Tampa, Florida, United States (WITHDRAWN)
- MetroDerm — Atlanta, Georgia, United States (COMPLETED)
- Norton Cancer Institute — Louisville, Kentucky, United States (WITHDRAWN)
- Northeast Dermatology Associates — Beverly, Massachusetts, United States (COMPLETED)
- Dermatology Surgery Associates — New York, New York, United States (WITHDRAWN)
- Rochester Dermatologic Surgery, P.C. — Victor, New York, United States (RECRUITING)
- Duke Cancer Center — Durham, North Carolina, United States (COMPLETED)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- Inova Schar Cancer Institute — Fairfax, Virginia, United States (RECRUITING)
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (RECRUITING)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (RECRUITING)
- Alfred Health — Melbourne, Victoria, Australia (RECRUITING)
- Fremantle Dermatology — Fremantle, Western Australia, Australia (RECRUITING)
- Radboud University Medical Center — Nijmegen, Gelderland, Netherlands (RECRUITING)
- Maastricht University Medical Center — Maastricht, Limburg, Netherlands (RECRUITING)
- The Netherlands Cancer Institute - Antoni van Leeuwenhoek — Amsterdam, Noord-Holland, Netherlands (RECRUITING)
- University of Groningen, University Medical Centre Groningen — Groningen, Netherlands (RECRUITING)
- Erasmus MC — Rotterdam, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Clinical Trial Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma, CSCC, BCC