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NCT02239900 · ClinicalTrials.gov registry record · Phase 1
Ipilimumab and Stereotactic Body Radiation Therapy (SBRT) in Advanced Solid Tumors
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 143
- Enrollment target
NCT02239900: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT02239900 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 143 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (138% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02239900, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 143 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of ipilimumab and stereotactic body radiation therapy (SBRT). The safety and effectiveness of these treatments given consecutively will also be studied. This is an investigational study. SBRT is FDA approved for the control of metastatic and primary tumors. Ipilimumab is FDA approved and commercially available for the treatment of metastatic melanoma that cannot be removed with surgery. The use of SBRT with ipilimumab is investigational. The study doctor can explain how the study drug is designed to work. Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.
Primary Outcome
MTD defined as highest dose level with less than 2 patients with dose limiting toxicity (DLT) out of at least six patients in the cohort. All enrolled participants will be considered in the DLT analysis. If at any time more than or equal to one third (33%) of participants at a dose level experience DLT, the MTD will be reassessed and the next lowest dose level for the combination therapy considered the MTD.
Interventions
- DRUG Ipilimumab
- RADIATION Stereotactic Body Radiation Therapy (SBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2014-08-26 |
| Est. Completion | 2019-10-25 |
| Phase | Phase 1 |
What the finished NCT02239900 record still lists
NCT02239900 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (138% higher).
The record links to 0 conditions, and to 2 interventions - of which Ipilimumab is the first listed.
NCT02239900 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02239900 about?
NCT02239900 is a clinical study titled "Ipilimumab and Stereotactic Body Radiation Therapy (SBRT) in Advanced Solid Tumors". The goal of this clinical research study is to find the highest tolerable dose of ipilimumab and stereotactic body radiation therapy (SBRT). The safety and effectiveness of these treatments given consecutively will also be studied. This is an investigational study. SBRT is FDA approved for the cont...
What is the current status of trial NCT02239900?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 143 participants. The study started on 2014-08-26. Estimated completion is 2019-10-25.
What interventions are being tested in trial NCT02239900?
The interventions under investigation include: Ipilimumab (DRUG), Stereotactic Body Radiation Therapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT02239900?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02239900's enrollment target sits among peer trials
143 401st of 2000 higher than 1,600 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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