PCCIG Project: Real-World Outcomes of Cemiplimab in Recurrent/Metastatic Cervical Cancer — a Polish–Czech Multicenter Collaboration

Background Immune checkpoint inhibitors have become an important component of cervical cancer management. Cemiplimab demonstrated a survival benefit in recurrent or metastatic cervical cancer (r/mCC); however, real-world data from Central and Eastern Europe remain limited. Differences in healthcare systems, treatment access, and patient characteristics may influence treatment outcomes and biomarker utility. Objectives The PCCIG project aims to evaluate real-world outcomes of cemiplimab in patients with r/mCC treated in Poland and the Czech Republic and to explore clinical and biological factors associated with treatment benefit. Study design Multicenter retrospective cohort study conducted in reference oncology centers in Poland and one collaborating center in the Czech Republic. Study population Patients with recurrent or metastatic cervical cancer treated with cemiplimab in routine clinical practice or within rescue access programs. Main outcomes Primary outcomes: overall survival (OS) progression-free survival (PFS) Secondary outcomes: objective response rate (ORR) disease control rate (DCR) Safety Exploratory outcomes: association between clinical and tissue biomarkers and treatment outcomes. Planned analyses The project includes predefined analyses: PCCIG-01 — tissue biomarkers and outcomes (histology, PD-L1 CPS, HPV status) PCCIG-02 — safety and immune-related adverse events PCCIG-03 — laboratory predictors of treatment outcomes Survival analyses will be performed using Kaplan–Meier methods and Cox proportional hazards models adjusted for predefined clinical confounders. Significance This project provides real-world evidence on cemiplimab effectiveness and biomarker utility in cervical cancer within Central and Eastern Europe. Findings may support optimization of patient selection and improve understanding of treatment outcomes in routine clinical practice.