Clinical Trial

Cutaneous Squamous Cell Carcinoma Treatment

Study Description

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

This is a randomized, double-blind, study that compares pembrolizumab 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).

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Biological - Pembrolizumab 400 mg

Administered by IV infusion on Day 1 of each 42-day cycle

Drug - Placebo

Administered by IV infusion on Day 1 of each 42-day cycle

Additional Information

Official Study 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)

Clinical Trial ID

NCT03833167

ParticipAid ID

bkRMra