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Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma

NCT04318717 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-11-28

No results posted yet for this study

Summary

This is an open-label, single center, one cohort, non-randomized, phase II study. The aim is to evaluate the efficacy and safety of the combination of hypofractionated radiotherapy (HRT) and pembrolizumab on local tumor control in mucosal melanoma patients. Treatment effect will be compared with historical radiation therapy-alone control data.

Conditions

  • Mucosal Melanoma of the Head and Neck

Interventions

DRUG

Pembrolizumab

Pembrolizumab is commercially available

RADIATION

Hypofractionated radiation therapy

It is preferred to leave at least 48 hours between fractions. Daily imaging to verify accurate set-up is mandatory.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • George Ansstas, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-29
Primary Completion
2030-07-31
Completion
2032-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04318717 on ClinicalTrials.gov