RecruitingMucosal Melanoma of the Head and Neck
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
Eligible age
16+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Washington University School of Medicine
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
Where it's recruiting
Missouri
St Louis
Source: ClinicalTrials.gov · NCT04318717 · last updated 2026-05-27