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Pembrolizumab and Radiation for Mucosal Melanoma

This study is looking at a combination treatment for mucosal melanoma, a type of skin cancer that starts in moist linings of the body like the mouth or nose. It combines pembrolizumab, a commercially available drug, with hypofractionated radiation therapy (radiation given in fewer, larger doses). Researchers want to see how well this combination controls the tumor locally. You might be able to join if you are at least 16 years old, have mucosal melanoma that has been surgically removed, and meet certain health requirements. The study plans to enroll 20 participants. The main goal is to measure the local tumor control rate one year after treatment is finished. The current recruitment status is unclear.

Study design
This is a Phase II, open-label study at a single center, meaning everyone receives the same treatment and both you and your doctors will know what treatment you are getting. It is not randomized and plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure local tumor control one year after you complete treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04318717

Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma

Recruiting
PHASE2Ages 16+InterventionalTreatment
Washington University School of Medicine
~20 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:PembrolizumabHypofractionated radiation therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local tumor control rate
Measured over 1 year after completion of treatment (estimated to be 2 years)

Conditions

Mucosal Melanoma of the Head and Neck

Explore related trials

Mucosal Melanoma

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

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

Who to contact

George Ansstas, M.D.
[email protected]
314-362-5677
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion

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.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.

What this trial measures

  • Local tumor control rate1 year after completion of treatment (estimated to be 2 years)

    Tumor control rate is defined as the percentage of subjects at 12 months who are free of local recurrence, regional recurrence, distant recurrence, second primary cancer, or death.