Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

Not Recruiting

Trial ID: NCT03889912


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

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)

Stanford Investigator(s)

Anne Lynn S. Chang, MD
Anne Lynn S. Chang, MD

Professor of Dermatology


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.


drug: Cemiplimab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Alexander Ayon Valencia

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