Trial Search Results

Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma

The main purpose of this study is to determine the safety and tolerability of cemiplimab (REGN2810) injected intralesionally in patients with recurrent cutaneous squamous cell carcinoma (CSCC). Secondarily, this study is also being done to test if cemiplimab can reduce the size of the participant's tumor by helping the immune system destroy the tumor.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator: Sanofi

Stanford Investigator(s):

Intervention(s):

  • Drug: Cemiplimab

Phase:

Phase 1

Eligibility


Key Inclusion Criteria

   - History of recurrent resectable CSCC that satisfies conditions as defined in the
   protocol

   - Patient must have measurable disease in the index lesion, as defined by modified WHO
   criteria. Measurable disease is defined as at least one lesion that is at least 1 cm
   in both of the longest perpendicular diameters.

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Key Exclusion Criteria

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events (irAEs)

   - Prior treatment with an agent that blocks the programmed cell death

   1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.

   - Prior treatment with other systemic immune modulating agent as defined in the protocol

   - M1 or N1, N2 (a, b, or c), or N3 CSCC. Patients with history of metastatic CSCC
   (distant or nodal), are excluded unless the disease-free interval is at least 3 years

   - Concurrent malignancies, other than those with negligible risk of metastasis or death.
   Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL),
   are excluded.

   - Patients with a history of solid organ transplant

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Alexander Ayon Valencia
650-498-5185
Not Recruiting