Testing Pembrolizumab versus Observation in Patients with Merkel Cell Carcinoma after Surgery

IRB/UVA Tracking #
21435
Principal Investigator
Elizabeth M Gaughan
Contact
Contact Phone
Official Trial Title
A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma
Study Description

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Merkel Cell Carcinoma for a research study. The purpose of the study is to compare the usual approach of post-surgery observation with or without radiation to using pembrolizumab with or without radiation after surgery. This drug, pembrolizumab, is already approved by the FDA for use in other cancers.

This study has 2 study groups:

Group 1 (Arm A)
If you are in this group, you will get the study drug pembrolizumab. You will get this drug through a vein in your arm once every cycle for 1 year. Each cycle lasts 21 days. This study has 17 cycles. You may or may not receive a course of radiation therapy. You should discuss with your study doctor about whether you will receive radiation therapy.

Group 2 (Arm B)
If you are in this group, you will be followed for observation for 1 year. You may or may not receive a course of radiation therapy. You should discuss with your study doctor about whether you will receive radiation therapy

After you finish your study treatment or observation, your doctor will continue to follow your condition for 4 years and watch you for side effects and signs that your cancer has come back. You will have clinic visits every 6 months during this follow-up period. This means you will keep seeing your doctor for a total of 5 years.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT03712605

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

No Compensation