RecruitingPhase 2NCT04318717

Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma

Adjuvant Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma


Sponsor

Washington University School of Medicine

Enrollment

19 participants

Start Date

May 29, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining pembrolizumab (an immunotherapy drug) with a specific type of radiation (hypofractionated radiation — a higher dose delivered over fewer sessions) can improve outcomes after surgery for mucosal melanoma, a rare type of melanoma that forms inside the body on moist surfaces (such as the mouth, nasal passages, or genitals). **You may be eligible if...** - You are at least 16 years old - You have mucosal melanoma that has been surgically removed - You have not received prior radiation therapy at the area being treated - You are in reasonably good physical condition (ECOG performance status 0, 1, or 2) - Your blood counts, liver function, and kidney function are within required ranges - You agree to use contraception during and after treatment **You may NOT be eligible if...** - You have previously been treated with pembrolizumab or similar immunotherapy drugs - You have active autoimmune disease - You are on immune-suppressing medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab is commercially available

RADIATIONHypofractionated radiation therapy

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


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT04318717