Trials / Completed
CompletedNCT03833167
Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pembrolizumab | 400 mg IV infusion |
| DRUG | Placebo | Placebo-matched IV infusion |
Timeline
- Start date
- 2019-04-01
- Primary completion
- 2024-06-28
- Completion
- 2026-01-20
- First posted
- 2019-02-06
- Last updated
- 2026-03-10
- Results posted
- 2025-07-22
Locations
181 sites across 24 countries: United States, Argentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Mexico, New Zealand, Norway, Poland, Portugal, Romania, Russia, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03833167. Inclusion in this directory is not an endorsement.