CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 450 enrolled
Drug / intervention
Pembrolizumab +1 morebiological
Likely dose
Pembrolizumab 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03833167
NCT03833167Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)

Merck Sharp & Dohme LLC·interventional·Posted Feb 6, 2019·Updated Mar 10, 2026

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab and Placebo for Carcinoma, Squamous Cell. Completed, enrolled 450 participants across 181 sites in 24 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Squamous Cell
CountriesArgentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Mexico, New Zealand, Norway, Poland, Portugal, Romania, Russia, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 6, 2019
Enrollment StartApr 1, 2019
Primary CompletionJun 28, 2024
Study CompletionJan 20, 2026
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 7.4 years ago

Interventions

Pembrolizumabbiological

400 mg IV infusion

Placebodrug

Placebo-matched IV infusion