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 not accepting patients for this trial.
- Drug: Cemiplimab
Key Inclusion Criteria
- History of recurrent resectable CSCC that satisfies conditions as defined in the
- 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),
- Patients with a history of solid organ transplant
- Has received a COVID-19 vaccination (initial series and booster) within 1 week of
planned start of study medication
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study