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NCT03903640 · ClinicalTrials.gov registry record · Phase 2
Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis
A Phase 2 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT03903640: Clinical Trial Phase 2 study, sponsored by Washington University School of Medicine.
NCT03903640 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03903640, a Phase 2 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
This phase II study will evaluate the safety of combining intermediate frequency electric field (TT Field) with immunotherapy in melanoma patients with brain metastasis. The data of this study will also inform whether this combination will offer advantage in progression free survival (PFS) and overall survival.
Primary Outcome
* The PFS time will be calculated as the duration of time from the date of first dose of study treatment to the date of earliest intracranial progression or death, whichever occurs first. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of a
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- DEVICE Optune
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-10-14 |
| Est. Completion | 2021-11-03 |
| Phase | Phase 2 |
Why NCT03903640 stopped before completion
NCT03903640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT03903640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03903640 about?
NCT03903640 is a clinical study titled "Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis". This phase II study will evaluate the safety of combining intermediate frequency electric field (TT Field) with immunotherapy in melanoma patients with brain metastasis. The data of this study will also inform whether this combination will offer advantage in progression free survival (PFS) and overa...
What is the current status of trial NCT03903640?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2019-10-14. Estimated completion is 2021-11-03.
What interventions are being tested in trial NCT03903640?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Optune (DEVICE).
Who is sponsoring clinical trial NCT03903640?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03903640's enrollment target sits among peer trials
2 2001st of 2000 the lowest 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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