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NCT02211131 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT02211131: Completed Phase 2 study, sponsored by Amgen.
NCT02211131 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02211131, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study Summary
This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma.
Primary Outcome
Recurrence free survival (RFS) is defined as the time from randomization to the date of event, and is presented as a Kaplan Meier estimate of time to events. The event for RFS is defined as the first of local, regional, or distant recurrence of melanoma or death due to any cause. Participants without a histopathology tumor-free margin (R0) surgical outcome or those who withdrew prior to surgery were considered an event at randomization. Participants without an event were censored at their last e
Interventions
- DRUG Talimogene Laherparepvec
- PROCEDURE Immediate surgical resection of melanoma lesion(s)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2015-02-03 |
| Est. Completion | 2022-04-28 |
| Phase | Phase 2 |
What the finished NCT02211131 record still lists
NCT02211131 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 2 interventions - of which Talimogene Laherparepvec is the first listed.
NCT02211131 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02211131 about?
NCT02211131 is a clinical study titled "Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma". This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma.
What is the current status of trial NCT02211131?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2015-02-03. Estimated completion is 2022-04-28.
What interventions are being tested in trial NCT02211131?
The interventions under investigation include: Talimogene Laherparepvec (DRUG), Immediate surgical resection of melanoma lesion(s) (PROCEDURE).
Who is sponsoring clinical trial NCT02211131?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02211131's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 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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