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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: Completed Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT03089606 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Association between intensity of C11-AMT PET at baseline, as measured by maximum standardized uptake value (SUV max) and objective response (OR) using computerized tomography images with intravenous contrast, as defined via RECIST v.1.1, at 12 weeks. Subject is considered responder if subject has CR or PR while subject is considered not-responder if they do not have CR or PR at 12 weeks. RECIST v.1.1: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% dec
Interventions
- DRUG Pembrolizumab
- DIAGNOSTIC_TEST CT scan
- DIAGNOSTIC_TEST FDG PET/CT scan
- DIAGNOSTIC_TEST C11-AMT PET scan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-04-19 |
| Est. Completion | 2023-07-01 |
| Phase | Phase 2 |
What the finished NCT03089606 record still lists
NCT03089606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03089606 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03089606's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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