Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-097
Prinicipal Investigator
Drabick, Joseph
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
EA6192
Title
A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop)
Objective
Primary Endpoints
To determine the 12 month event free survival (EFS) rate following discontinuation of anti-PD-1 therapy in patients with disease control and negative FDG-PET/CT scan or biopsy for residual disease after 12 months of anti-PD-1 therapy (Arm A). Event is defined as recurrence, progression or melanoma-specific death.

Secondary Endpoints
To determine rates of pathologic response in patients with tumor biopsies where positive hypermetabolic activity was present on FDG-PET/CT scan after 12 months of anti-PD-1 therapy (Arm B).
To determine the overall 24 month EFS.
To determine overall survival from start of anti-PD-1 therapy.
To determine percentage for patients who remain on treatment beyond 12 months because of positive FDG-PET/CT scan and positive biopsy for residual disease (or unable to obtain a biopsy).
To determine incidence rates of treatment-related adverse events beyond 12 months from start of treatment in patients who discontinue anti-PD-1 therapy at 12 months and in patients who continue anti-PD-1 therapy beyond 12 months. (Arm A vs. Arm B).

Exploratory Endpoints
To assess agreement in determining FDG-PET/CT positivity between the local site read and central review.
To determine if metabolic response on serial FDG-PET/CT from pre-therapy to 12 months of anti-PD-1 therapy, as determined centrally by various criteria, is associated with EFS.
To determine if metabolic response on serial FDG-PET/CT from 12 to 24 months after start of anti-PD-1 therapy, as determined centrally by various criteria, is associated with EFS.
Applicable Disease Sites
Melanoma, Skin
Status
Open
Participating Institutions
Hershey Medical Center