Trial purpose
Cancer treatment
Tumor type
Skin
Age
18+
Clinical summary
Summary
This study is researching an experimental drug called cemiplimab. Cemiplimab is a type of immunotherapy called a checkpoint inhibitor, that targets and blocks a protein called PD-1 on the surface of immune cells called T-cells. Blocking the PD-1 protein triggers the T-cells to find and kill cancer cells.
The first part of the study tested several different doses of cemiplimab given weekly for up to 12 weeks.
Each eligible participant will receive injections into the cancer lesion (intralesional) of cemiplimab every week, or at less frequent dosing, at the assigned dose level for 3-12 weeks prior to scheduled surgery.
Conditions
This trial is treating people with recurrent, resectable cutaneous squamous cell carcinoma (CSCC) or basal cell carcinoma (BCC)
Eligibility
Inclusion
- Dose Escalation: History of recurrent resectable CSCC or BCC (Cohort C and I only) that satisfies conditions as defined in the protocol
- Patients must have measurable disease in the index lesion, defined as 1-2 cm in the longest diameter
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Exclusion
- 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)
- 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 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
- 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
- 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.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Regeneron Pharmaceuticals
Scientific 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)
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