Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma

  • STATUS
    Recruiting
  • End date
    Jul 11, 2027
  • participants needed
    16
  • sponsor
    Washington University School of Medicine
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Updated on 14 March 2022
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Summary

This is an open-label, single center, one cohort, non-randomized, phase I/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.

Details
Condition Mucosal Melanoma of the Head and Neck
Treatment Pembrolizumab, hypofractionated radiation therapy
Clinical Study IdentifierNCT04318717
SponsorWashington University School of Medicine
Last Modified on14 March 2022

Eligibility

 Yes No Not Sure

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

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
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
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