SWOG S1801

Trial Overview

Official Title

A phase II randomized study of adjuvant vs. neoadjuvant MK-3475 (Pembrolizumab) for clinically detectable stage III-IV high-risk melanoma

Study Purpose

To compare outcomes of receiving the study drug either before and after or only after surgery.

Diagnosis

Have stage III or IV resectable melanoma in order to be eligible for this study.

Eligibility

Must not have received previous neoadjuvant treatment for their melanoma. Patients may have received prior non-immunotherapy adjuvant therapy.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

ARM I: Adjuvant Arm. Will first undergo surgery, then a few weeks later, will receive pembrolizumab for approximately one year (18 total doses).
ARM II: Neoadjuvant Arm. Will receive pembrolizumab for a couple months (3 doses) and then have surgery a few weeks later. After recovery from surgery, patients will receive additional pembrolizumab (15 doses), totaling together 18 doses for before and after surgery.

For more information, visit ClinicalTrials.gov

Key Participation Requirements

Trial Location(s)

Methodist Estabrook Cancer Center Methodist Jennie Edmundson Hospital

Gender

Male or Female

Age

19 years and older

Enrollment Status

Recruiting

Phase

Phase II

Methodist Health System Trial Code

S1801