This study is currently not recruiting participants.

A Phase III Randomized Trial Comparing High Dose Interferon to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma

Investigating Treatments for Resected Stage III and IV Melanoma

Not Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to compare the effects, good and/or bad, of the experimental drug MK-3475 (also called pembrolizumab) to the usual treatment with interferon alfa-2b.

Detailed description of study

The purpose of this study is to compare overall survival (OS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab); among patients who are PD-L1 positive, to compare OS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab; to compare relapse-free survival (RFS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475(pembrolizumab); and among patients who are PD-L1 positive, to compare RFS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: melanoma
  • Age: 18 years - 100 years
  • Gender: All

This study investigates the effects of an investigational medication compared to usual treatment for patients with resected Stage III and IV melanoma. Melanoma is a type of skin cancer that can spread to other parts of the body. The study focuses on comparing overall survival and relapse-free survival between the investigational medication and a standard treatment known as interferon alfa-2b.

Participants will receive either the investigational medication or the standard treatment. The study will also look at how the treatments affect patients who have a specific protein called PD-L1. PD-L1 is a protein that can affect how the immune system responds to cancer. The study procedures include regular monitoring and assessments to evaluate the effects of the treatments.

  • Who can participate: This study is for patients with resected Stage III and IV melanoma. Participants must have a confirmed diagnosis of melanoma, meet specific health criteria, and fall within the age range of 18 to 75 years.
  • Study details: Participants will be assigned to one of two study arms: one receiving the investigational medication and the other receiving the standard treatment. A placebo is not used in this study.
Updated on 19 Feb 2024. Study ID: 1603034282 (S1404)

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