CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Pembrolizumab +3 moredrug
Likely dose
Pembrolizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03089606
NCT03089606Phase 2Completed
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Pembrolizumab in Systemic Treatment-Naïve Distant Metastatic Melanoma and Exploration of Use of Baseline 11C-methyl-L-tryptophan (C11-AMT) PET Imaging as a Predictive Imaging Biomarker of Antitumor Response

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Mar 24, 2017·Updated Nov 15, 2023

In Brief

A Phase 2 clinical trial evaluating FDG PET/CT scan, C11-AMT PET scan, and 2 other interventions for Melanoma. Completed, enrolled 27 participants across 2 sites.

Detailed Summary

Explore the association between intensity of 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) at baseline, as measured by mean standardized uptake value (SUVmax) at each lesion, total tumor metabolic volume, measurement of intra-tumoral and inter-lesional heterogeneity, with objective response rate (ORR) at 12 weeks (as defined via RECIST 1.1) to pembrolizumab in patients with treatment-naïve metastatic melanoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 24, 2017
Enrollment StartApr 19, 2017
Primary CompletionApr 1, 2021
Study CompletionJul 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 9.3 years ago

Interventions

FDG PET/CT scanother

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

C11-AMT PET scanother

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

Pembrolizumabdrug

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

CT scanother

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