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NCT02097732 · ClinicalTrials.gov registry record · Phase 2
Ipilimumab Induction in Patients With Melanoma Brain Metastases Receiving Stereotactic Radiosurgery
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT02097732: Clinical Trial Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT02097732 is a Phase 2 study that was terminated before completion, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02097732, a Phase 2 study, was terminated before completion, sponsored by University of Michigan Rogel Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a study to test the efficacy of using standard immune therapy for melanoma prior to stereotactic radiosurgery (ipilimumab induction), as compared to stereotactic radiosurgery followed by immune therapy. The study's hypothesis is that ipilimumab induction is as good as or better than controlling brain metastases as compared to stereotactic radiosurgery followed by immune therapy.
Primary Outcome
The number of patients in each arm who are free from progression in the index (radiated) lesions in the brain at 6 months. Immune related response criteria was used to assess response to treatment. Immune-related Progressive Disease (irPD) in this trial is defined as an increase in tumor burden ≥25% relative to nadir (minimum recorded tumor burden), with confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented.
Interventions
- DRUG Ipilimumab
- PROCEDURE Stereotactic Radiosurgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-04 |
| Est. Completion | 2020-07 |
| Phase | Phase 2 |
Why NCT02097732 stopped before completion
NCT02097732 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Ipilimumab is the first listed.
NCT02097732 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02097732 about?
NCT02097732 is a clinical study titled "Ipilimumab Induction in Patients With Melanoma Brain Metastases Receiving Stereotactic Radiosurgery". This is a study to test the efficacy of using standard immune therapy for melanoma prior to stereotactic radiosurgery (ipilimumab induction), as compared to stereotactic radiosurgery followed by immune therapy. The study's hypothesis is that ipilimumab induction is as good as or better than controll...
What is the current status of trial NCT02097732?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2014-04. Estimated completion is 2020-07.
What interventions are being tested in trial NCT02097732?
The interventions under investigation include: Ipilimumab (DRUG), Stereotactic Radiosurgery (PROCEDURE).
Who is sponsoring clinical trial NCT02097732?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02097732's enrollment target sits among peer trials
4 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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