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Melanoma Treatment Study

Clinical Trial Title: 
High dose interferon compared with pembrolizumab for patients with melanoma.
Clinical Trial Protocol ID: 
16062407
Clinical Trial Investigator Name: 
Timothy Kuzel, MD
Clinical Trial Protocol Description: 

To provide interferon or pembrolizumab treatment for patients with high risk resected melanoma and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have completely resected melanoma of cutaneous origin or of unknown primary and must be classified as stage IIIA (N2a), IIIB, IIIC, or stage IV melanoma. Melanoma of mucosal or other non-cutaneous origin are eligible.
  • Have initial presentation of melanoma, or, at the time of the first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site. Nodal, satellite/in-transit metastasis, distant metastases or disease in a prior complete lymphadenectomy basin must have been confirmed histologically by hematoxylin and eosin (H & E) stained slides.
  • Undergo an adequate wide excision of the primary lesion, if present, at initial presentation of melanoma. Patients with previously diagnosed melanoma must have had all current disease resected with pathologically negative margins and must have no evidence of disease at the primary site or must undergo re-resection of the primary site.
  • Have multiple regional nodal basin involvement. Gross or microscopic extracapsular nodal extension is permitted.

You will be excluded from the study if any of the following criteria apply to you:

  • Have melanoma of ocular origin.
  • Have a history of brain metastases.
  • Have received neoadjuvant treatment for their melanoma. Patients must not have had prior immunotherapy including, but not limited to ipilimumab, interferon alfa-2b, high dose IL-2, PEG-IFN, anti-PD-1, anti-PD-L1 intra-tumoral or vaccine therapies.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Dermatology
Melanoma and Soft Tissue
Contact Phone: 
(312) 942-5526
Contact Name: 
Pam Sroka, BS, MT(ASCP), BSN, RN, CCRC