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Melanoma Research Study

In this study, we want to learn if a combination of two drugs (fianlimab and cemiplimab) is an effective treatment compared to a drug called pembrolizumab for people who have had melanoma removal surgery but are still at high risk for recurrence of the disease.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

The study involves screening visit with questionnaire and testing for infections. During the study, you will have a biopsy, blood draws, urine sample collections, imaging scans (ex: CT/MRI/PET-CT), ECG. You will be randomly selected to the combination drug groups or standard drug group via IV infusion. You or your doctor or the staff will not know which group you will be in. Dosing will be given once every 3 weeks for 1 year. If the subject was not on the trial, the subject would be treated with infusions every 3 or 4 weeks for one year.

In-person visits:
25-30

Total length of participation:
5 years

Looking for Specific Volunteers

Able to participate:

You have melanoma that was surgically removed within the last 12 weeks
You have not received anti-cancer or radiation therapy for melanoma in the last 5 years.
You have adequate bone marrow, liver, and kidney function
You are not pregnant or planning to be pregnant or father a child while participating on the trial

Not eligible if:

You have autoimmune disease
You have HBV or HCV infection
You have another progressing cancer
You have cardiovascular disease

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Frances Collichio
Medicine- Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Melanoma)

IRB Number

22-2836

ClinicalTrials.gov

NCT05352672

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH. This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

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