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NCT03089606 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.

Completed
Registry status
Phase 2
Development phase
27
Enrollment target

NCT03089606 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 27 participants.

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The verdict

NCT03089606, a Phase 2 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
27 participants
Enrollment target

Study 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.

Interventions

  • DRUG Pembrolizumab
  • DIAGNOSTIC_TEST CT scan
  • DIAGNOSTIC_TEST FDG PET/CT scan
  • DIAGNOSTIC_TEST C11-AMT PET scan

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2017-04-19
Est. Completion 2023-07-01
Phase Phase 2

What the Registry Record Tells You About NCT03089606

The ClinicalTrials.gov registry entry for NCT03089606 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.

NCT03089606 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03089606 about?

NCT03089606 is a clinical study titled "Pembrolizumab TX-naive Distant Mets Melanoma and Use of (C11-AMT) PET at Baseline as Imaging Biomarker". 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 obje...

What is the current status of trial NCT03089606?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2017-04-19. Estimated completion is 2023-07-01.

What interventions are being tested in trial NCT03089606?

The interventions under investigation include: Pembrolizumab (DRUG), CT scan (DIAGNOSTIC_TEST), FDG PET/CT scan (DIAGNOSTIC_TEST), C11-AMT PET scan (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT03089606?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.