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

Launched by REGENERON PHARMACEUTICALS · Mar 22, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called cemiplimab for adults with two types of skin cancer: Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC). The goal of the trial is to find out how safe the drug is and how well it works on tumors. Participants will receive cemiplimab through injections once a week for 12 weeks, and the study will monitor any side effects and how the drug affects the cancer.

To be eligible for the trial, participants should have a history of CSCC or BCC that can be treated, with a measurable tumor size of 1-2 cm. They should also be in good overall health, which means they can perform daily activities without much difficulty. However, people with certain autoimmune diseases, previous treatments that target the same cancer pathways, or recent serious health issues may not qualify. If you or a loved one are interested, it could be a chance to access a new treatment while contributing to important medical research.

Gender

ALL

Eligibility 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.