Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorWashington University School of Medicine
About this trial
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 criteria
Qualifiers
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%)
Absolute neutrophil count ≥ 1,200/mcL
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pembrolizumab
- Hypofractionated radiation therapy
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov