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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Pembrolizumab
DrugPembrolizumab is commercially available
Hypofractionated radiation therapy
RadiationIt is preferred to leave at least 48 hours between fractions. Daily imaging to verify accurate set-up is mandatory.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Pembrolizumab + Hypofractionated radiation therapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Local 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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov