Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma

Conditions

• Mucosal Melanoma of the Head and Neck

Eligibility Criteria

Sex

ALL

Age

16 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — DRUG
  Pembrolizumab is commercially available
• Hypofractionated radiation therapy — RADIATION
  It is preferred to leave at least 48 hours between fractions. Daily imaging to verify accurate set-up is mandatory.

Study Details

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.

Key Dates

Start date

May 29, 2020

Status verified

May 2026

Primary completion

Jul 31, 2030

Completion

Jul 31, 2032

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Pembrolizumab + Hypofractionated radiation therapy
  * Pembrolizumab will be given intravenously over 30 minutes (-5/+10 minutes) at a dose of 200 mg on an outpatient basis on Day 1 of each 21-day cycle for a total of up to 12 months (17 cycles). * Hypofractionated radiation therapy may be given at any point during the first 2 cycles of pembrolizuimab. It should begin within 90 days of surgical resection. Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) are to be used exclusively. IMRT or IMPT will be delivered twice per week in five fractions of 6 Gy given over 2.5 weeks totaling 30 Gy.

Primary Outcome Measure

Local tumor control rate [ Time Frame: 1 year after completion of treatment (estimated to be 2 years) ]

Central Contacts

• George Ansstas, M.D.
  314-362-5677
  [email protected]

Locations (1)

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