NCI Suspends Phase 3 Cemiplimab Trial in Resectable Skin Cancer

The National Cancer Institute has suspended enrollment in C-PRE (NCT06568172), a phase 3 randomized trial evaluating cemiplimab-rwlc as perioperative systemic therapy in patients with resectable cutaneous squamous cell carcinoma (CSCC). The suspension, reflected in an updated ClinicalTrials.gov registry entry this week, offers no public explanation for the pause.

C-PRE was designed to enroll 420 patients at NCI-affiliated sites and randomly assign them to perioperative cemiplimab plus surgery versus surgery alone, with recurrence-free survival as the primary endpoint. Cemiplimab has an established role in unresectable CSCC, but perioperative immunotherapy in the resectable setting had not previously been evaluated in a phase 3 trial. The study opened in February 2025 and had been accruing for approximately 16 months before the suspension took effect.

The ClinicalTrials.gov record notes a safety monitoring board review as the impetus for the pause, but no further information has been made public. The NCI issued no statement as of Sunday evening, and the patient community organization Skin Cancer Foundation could not be reached for comment.

The suspension puts C-PRE in a pattern that has become increasingly visible: NCI-sponsored immunotherapy trials have been placed on clinical hold or paused in recent months with minimal public disclosure. A second NCI-sponsored immunotherapy study, in an unrelated indication, was also suspended in the same calendar window, according to the registry.

Dermatologic oncologists say the clinical impact on patients is limited for now—cemiplimab retains its current standing in unresectable disease, and patients in the resectable setting who were not yet enrolled can pursue surgery on standard timelines. But the scientific community is watching closely: if C-PRE does not resume, the perioperative immunotherapy question in resectable CSCC may not be answerable without a new sponsor.

The Vital Record has contacted the NCI Office of Communications for comment and will update this story when a response is received.