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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Pembrolizumab is commercially available
It is preferred to leave at least 48 hours between fractions. Daily imaging to verify accurate set-up is mandatory.
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGLocal tumor control rate
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.
Time frame: 1 year after completion of treatment (estimated to be 2 years)
Number of treatment-related grade 3 or greater adverse events
The total number of adverse events determined to be treatment related and grade 3 or higher as assessed using CTCAE v5.0 criteria.
Time frame: Baseline through 90 days after end of treatment (estimated to be 15 months)
Number of treatment discontinuations due to treatment-related adverse events
The total number of participants who discontinued treatment due to treatment-related adverse events as assessed using CTCAE v5.0 criteria.
Time frame: Through end of treatment (estimated to be 1 year)
Relapse-free survival (RFS)
-Defined as the duration of time from the start date of study treatment to the date of earliest disease relapse or death, whichever occurs first. Patients who neither relapse nor die by the data cutoff date will be censored at the last follow up date.
Time frame: At 3 years after completion of treatment (estimated to be 4 years)
Distant metastasis-free survival
-Defined as the duration of time from the start date of study treatment to the date of appearance of a distant metastasis or death, whichever occurs first. Patients who neither develop distant metastasis nor die by the data cutoff date will be censored at the last follow up date.
Time frame: At 3 years after completion of treatment (estimated to be 4 years)
Overall survival
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-Defined as the duration of time from the start date of study treatment to death from any cause. Patients who are alive by the data cutoff date will be censored at the last follow up date.
Time frame: At 3 years after completion of treatment (estimated to be 4 years)