Actively Recruiting
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
Led by Washington University School of Medicine · Updated on 2025-11-28
19
Participants Needed
1
Research Sites
635 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed mucosal melanoma that has undergone surgical resection
- No prior radiation therapy within the area of interest
- At least 16 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (Karnofsky score of 70% or higher)
- Normal bone marrow and organ function, including absolute neutrophil count ≥ 1,200/mcL, platelets ≥ 100,000/mcL, total bilirubin ≤ 1.5 times institutional upper limit of normal, AST/ALT ≤ 3.0 times institutional upper limit of normal, and creatinine clearance > 30 mL/min
- Agreement to use adequate contraception during the study and for 6 months after last pembrolizumab dose
- Ability to understand and sign informed consent
You will not qualify if you...
- History of other malignancy unless treatment completed at least 2 years ago with no evidence of disease
- Prior radiation therapy within the area of interest
- Currently receiving other investigational agents
- Presence of metastatic disease
- Allergic reactions to pembrolizumab or similar agents
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, or arrhythmia
- Immunodeficiency or systemic steroid/immunosuppressive therapy within 7 days before treatment (except up to 10 mg/day prednisone)
- Active autoimmune disease requiring systemic treatment in past 2 years (except replacement therapy and up to 10 mg/day prednisone)
- History or current pneumonitis/interstitial lung disease requiring steroids >10 mg prednisone
- Receipt of live vaccine within 30 days of treatment start
- Pregnant or breastfeeding; women of childbearing potential must have negative pregnancy test within 14 days
- HIV patients with CD4+ counts < 350 cells/mcL or recent AIDS-defining infections; must be on effective antiretroviral therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
G
George Ansstas, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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