Loading clinical trials...

Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma

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

NCT04318717•Washington University School of Medicine

View on ClinicalTrials.gov

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

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed mucosal melanoma that has undergone surgical resection. Patient must not have received prior radiation therapy within the area of interest.
•At least 16 years of age.
•Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%)
•Normal bone marrow and organ function as defined below:
•* Absolute neutrophil count ≥ 1,200/mcL
•* Platelets ≥ 100,000/mcL
•* Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN)
•* AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
•* Creatinine clearance \> 30 mL/min by Cockcroft-Gault
•The effects of pembrolizumab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and 6 months after last dose of pembrolizumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after last dose of pembrolizumab.
+1 more criteria

Exclusion Criteria

•A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
•Received radiation therapy within the area of interest.
•Currently receiving any other investigational agents.
•Metastatic disease.
•A history of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or other agents used in the study.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of up to 10 mg/day of prednisone or equivalent is approved and does not exclude the patient from the trial.
•Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, \> 10 mg of prednisone per day, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. The use of up to 10 mg/day of prednisone or equivalent is approved and does not exclude the patient from the trial.
•Has a history of (non-infectious) pneumonitis/Interstitial lung disease that required maintenance steroids (\>10 mg of prednisone) or current pneumonitis/interstitial lung disease.
•Has received a live vaccine or live-attenuated vaccination within 30 days of planned treatment start. Administration of killed vaccines is allowed.
+2 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

May 29, 2020

Primary Completion Date

July 31, 2030

Completion Date

July 31, 2032

Last Updated

November 28, 2025

Enrollment

ESTIMATED participants

Conditions

Mucosal Melanoma of the Head and Neck

Interventions

Pembrolizumab

DRUG

Hypofractionated radiation therapy

RADIATION

Contacts

George Ansstas, M.D.

CONTACT

314-362-5677 gansstas@wustl.edu

Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma

NCT03220009

Cervical CarcinomaEsophageal Carcinoma+15 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions