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NCT03765918 · ClinicalTrials.gov registry record · Phase 3

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

A Phase 3 study of Head and Neck Neoplasms, sponsored by Merck Sharp & Dohme.

Active
Registry status
Phase 3
Development phase
714
Enrollment target
20
Study locations

NCT03765918 is a Phase 3 study of Head and Neck Neoplasms that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 714 participants, above the 235-participant average among 23 other Head and Neck Neoplasms trials with a reported enrollment target (204% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT03765918, a Phase 3 study of Head and Neck Neoplasms, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
714 participants
Enrollment target
20
Study locations

Study Summary

This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

Conditions Studied

Head and Neck Neoplasms

Interventions

  • BIOLOGICAL Pembrolizumab 200 mg
  • RADIATION Radiotherapy 60 Gray
  • RADIATION Radiotherapy 66 Gray
  • RADIATION Radiotherapy 70 Gray
  • DRUG Cisplatin 100 mg/m^2

Study Locations (20)

California

  • Moores Cancer Center ( Site 1885) - La Jolla
  • University of Southern California Norris Comprehensive Cancer Center ( Site 1850) - Los Angeles
  • Hoag Memoriall Hospital Presbyterian ( Site 2056) - Newport Beach
  • UC Davis Health System ( Site 1864) - Sacramento
  • St. Joseph Heritage Healthcare ( Site 1806) - Santa Rosa

Florida

  • University of Florida ( Site 1832) - Gainesville
  • University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008) - Miami
  • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 2054) - Orlando
  • Orlando Health Cancer Institute ( Site 2061) - Orlando

Illinois

  • Rush University Medical Center ( Site 1823) - Chicago
  • NorthShore University HealthSystem ( Site 1812) - Evanston
  • Loyola University Medical Center [Maywood, IL] ( Site 1817) - Maywood

District of Columbia

  • MedStar Washington Hospital Center ( Site 2062) - Washington D.C.
  • George Washington University Medical Faculty Associates ( Site 2035) - Washington D.C.

Idaho

  • Saint Alphonsus Regional Medical Center ( Site 2021) - Boise
  • Beacon Cancer Care ( Site 2052) - Post Falls

Colorado

  • University of Colorado Cancer Center ( Site 1838) - Aurora

Kansas

  • University of Kansas Cancer Center ( Site 2004) - Westwood

Kentucky

  • University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069) - Lexington

Trial Details

FieldValue
Enrollment Target 714 participants
Start Date 2018-12-17
Est. Completion 2026-09-10
Phase Phase 3

Sponsor

Merck Sharp & Dohme

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03765918

The ClinicalTrials.gov registry entry for NCT03765918 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 714 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 235-participant average among 23 other Head and Neck Neoplasms trials with a reported enrollment target (204% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Head and Neck Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab 200 mg is the first listed.

NCT03765918 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT03765918 about?

NCT03765918 is a clinical study titled "Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)". This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, ...

What is the current status of trial NCT03765918?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 714 participants. The study started on 2018-12-17. Estimated completion is 2026-09-10.

What conditions does trial NCT03765918 study?

This clinical trial studies the following conditions: Head and Neck Neoplasms.

What interventions are being tested in trial NCT03765918?

The interventions under investigation include: Pembrolizumab 200 mg (BIOLOGICAL), Radiotherapy 60 Gray (RADIATION), Radiotherapy 66 Gray (RADIATION), Radiotherapy 70 Gray (RADIATION), Cisplatin 100 mg/m^2 (DRUG).

Who is sponsoring clinical trial NCT03765918?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03765918 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.