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COMPLETED Phase 3

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

NCT03833167 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Placebo

Study Locations (20)

California

  • City of Hope Medical Center ( Site 1505) — Duarte
  • UCSD Moores Cancer Center ( Site 1561) — La Jolla
  • UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568) — Los Angeles
  • University of California Davis Comprehensive Cancer Center ( Site 1560) — Sacramento
  • Stanford University Medical Center ( Site 1503) — Stanford

Florida

  • Boca Raton Regional Hospital ( Site 1551) — Boca Raton
  • UF Health ( Site 1511) — Gainesville
  • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544) — Miami

Massachusetts

  • Massachusetts General Hospital ( Site 1518) — Boston
  • Dana Farber Cancer Center ( Site 1519) — Boston

New York

  • Northwell Health/ RJ Zuckerberg Cancer Center-Medical Oncology ( Site 1565) — Lake Success
  • Icahn School of Medicine at Mount Sinai ( Site 1575) — New York

Alabama

  • University of South Alabama, Mitchell Cancer Institute ( Site 1562) — Mobile

Colorado

  • University of Colorado Cancer Center ( Site 1506) — Aurora

Connecticut

  • Smilow Cancer Center at Yale-New Haven ( Site 1507) — New Haven

Georgia

  • Winship Cancer Institute of Emory University ( Site 1512) — Atlanta

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2019-04-01
Est. Completion 2026-01-20
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03833167

The ClinicalTrials.gov registry entry for NCT03833167 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Carcinoma, Squamous Cell appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03833167 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03833167 about?

NCT03833167 is a clinical study titled "Pembrolizumab (MK-3475) 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 (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 pr...

What is the current status of trial NCT03833167?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2019-04-01. Estimated completion is 2026-01-20.

What conditions does trial NCT03833167 study?

This clinical trial studies the following conditions: Carcinoma, Squamous Cell. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03833167?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03833167?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03833167 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial