Posted: Wednesday, June 15, 2022
Danny Rischin, MD, of Peter MacCallum Cancer Centre, Melbourne, Australia, and colleagues will conduct a phase III study to evaluate the monoclonal antibody cemiplimab-rwlc as an adjuvant treatment for patients with high-risk cutaneous squamous cell carcinoma after surgery and radiation therapy. The testing of cemiplimab is based on previous surgical and clinicopathologic study findings. The trial details were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS9592).
The study is expected to enroll 412 patients from about 100 sites in North and South America, Europe, and Asia-Pacific regions. Enrolled patients must have at least one of the following high-risk criteria: nodal disease with extracapsular extension and at least one node larger than 20 mm or at least three lymph nodes positive on surgical pathology report, regardless of extracapsular extension; in-transit metastases; a locally advanced (T4) lesion; perineural invasion; and recurrent cutaneous squamous cell carcinoma with at least one other risk factor. Additionally, a protocol amendment allows patients with chronic lymphocytic leukemia who are not on active treatment to be enrolled. Enrolled patients must have completed postoperative radiotherapy (minimum total dose of 50 Gy within 10 weeks of study randomization).
The key objective is to compare disease-free survival. Secondary objectives will focus on overall survival, freedom from locoregional relapse, and distant relapse with adjuvant cemiplimab versus placebo.
The study will be conducted in two parts. In part 1, which will be blinded, patients will be randomly assigned to receive cemiplimab at 350 mg or placebo intravenously every 3 weeks for 12 weeks. After this treatment, patients will receive either cemiplimab at 700 mg or placebo every 6 weeks for 36 weeks. Part 2 will be unblinded. Patients who experienced disease recurrence with placebo or cemiplimab for more than 3 months after completing 48 weeks of treatment in part 1 will be eligible to receive open-label cemiplimab for up to 96 weeks.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.