Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

Summary

This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).

Timeline

Start

2019-04-01

Primary completion

2024-06-28

Completion

2026-01-20

Outcome

Missed primary endpoint

registry analysis (superiority test); Pembrolizumab vs Placebo; p = 0.07243; Hazard Ratio (HR) 0.76 (95% CI 0.53 to 1.10); Log Rank; NCT03833167 ↗

Drugs

Indications