Pembrolizumab TX-naive Distant Mets Melanoma and Use of (C11-AMT) PET at Baseline as Imaging Biomarker

PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

April 19, 2017

Primary Completion Date

April 1, 2021

Study Completion Date

July 1, 2023

Conditions
Melanoma
Interventions
DIAGNOSTIC_TEST

FDG PET/CT scan

18F-fluorodeoxy glucose (FDG) positron emission tomography (PET) with intravenous (IV) contrast images are obtained before and at the end study treatment (pembrolizumab infusion).

DIAGNOSTIC_TEST

C11-AMT PET scan

11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) images are obtained before study treatment (pembrolizumab infusion).

DRUG

Pembrolizumab

200 mg Pembrolizumab IV administered over 30 minutes on day 1. Repeat every 3 weeks for 4 cycles, until progression, or subject withdrawal for other reasons

DIAGNOSTIC_TEST

CT scan

Computerized tomography (CT) images are taken without IV contrast before the treatment (pembrolizumab infusion) and with IV contrast 3 months after the treatment start.

Trial Locations (2)

27599

Lineberger Comprehensive Cancer Center, Chapel Hill

27607

UNC Rex Healthcare, Raleigh

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

UNC Lineberger Comprehensive Cancer Center

OTHER

NCT03089606 - Pembrolizumab TX-naive Distant Mets Melanoma and Use of (C11-AMT) PET at Baseline as Imaging Biomarker | Biotech Hunter | Biotech Hunter