Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCLA UCSD
Dates
study started
completion around

Description

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).

Official Title

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)

Keywords

Carcinoma, Squamous Cell, Programmed Cell Death-1 (PD-1), Programmed Cell Death 1, PD1, Programmed Cell Death Ligand 1 (PD-L1), Programmed Cell Death Ligand 2 (PD-L2), PDL1, PDL2, Carcinoma, Squamous Cell Carcinoma, Pembrolizumab, Pembrolizumab 400 mg

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trial Information Plain Language Summary
ID
NCT03833167
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 450 people participating
Last Updated