Adjuvant Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
Washington University School of Medicine
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 range
- 16+ years
- Sex
- All
- Healthy volunteers
- No
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 Cock…
Interventions
- DrugPembrolizumab
Pembrolizumab is commercially available
- RadiationHypofractionated radiation therapy
It is preferred to leave at least 48 hours between fractions. Daily imaging to verify accurate set-up is mandatory.
Location
- Washington University School of MedicineSt Louis, Missouri