NCT06981325

Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients

Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (CEMI-first) - An Open Label, Single Arm, Prospective Phase II Trial of the DeCOG Network

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is an open-label, singel arm, prospective, multicenter phase II trial evaluating the efficacy and safety of Cemiplimab when applied as first-line therapy in patients with locally advanced basal cell carcinoma (BCC), which were not pretreated with hedgehog inhibitors (HHI).

Detailed description

The present study is an explorative, investigator-initatied, single-arm, multicentre phase II trial. Patients with locally advanced BCC without pretreatment with hedgehog inhibitors such as vismodegib and sonidegib will receive Cemiplimab (350 mg, i.v.) at day 1 of each 21 days cycle for up to 12 months (max. 17 cycles) or until intolerable toxicity or disease progression, whatever occurs first. All patients will be followed up until death or for up to 12 months after last patient last application of Cemiplimab. The treatment response will be assessed every 12 weeks (± 7 days) during the treatment and the follow up phase. In addition, tumor samples will be collected and used for translational research providing the basis for the establishment of potential biomarkers correlating with the efficacy of Cemiplimab. The primary objective of this study is to evaluate the efficacy of Cemiplimab when applied as first-line treatment in advanced, HHI naïve BCC measured by objective response rate (ORR) after 6 months of treatment. Secondary objective is to evaluate the safety and tolerability of Cemiplimab as first-line treatment in advanced BCC.

Conditions

• Basal Cell Carcinoma (BCC)
• First Line Treatment

Interventions

Type	Name	Description
DRUG	Cemiplimab	Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for up to 12 months (max. 17 cycles).

Timeline

• Start date: 2025-08-07
• Primary completion: 2028-10-01
• Completion: 2029-07-01
• First posted: 2025-05-20
• Last updated: 2026-03-11

Locations

7 sites across 1 country: Germany