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NCT01497808 · ClinicalTrials.gov registry record · Phase 1
Radvax™: A Stratified Phase I/II Dose Escalation Trial OF Hypofractionated Radiotherapy Followed BY Ipilimumab IN Metastatic Melanoma
A Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01497808 is a Phase 1 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 22 participants.
The verdict
NCT01497808, a Phase 1 study, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The primary objective is to determine the maximum tolerated hypofractionated radiotherapy dose (MTD) to a solitary metastatic focus ('index lesion') when followed by ipilimumab, in metastatic melanoma patients without brain involvement The secondary objectives are to determine late toxicity, immune-related clinical responses and immune pharmacodynamic changes after hypofractionated radiotherapy followed by ipilimumab
Interventions
- RADIATION Stereotactic Body Radiation Therapy
- DRUG Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-11-29 |
| Est. Completion | 2015-10-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01497808
The ClinicalTrials.gov registry entry for NCT01497808 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abramson Cancer Center at Penn Medicine, which has 402 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Stereotactic Body Radiation Therapy is the first listed.
NCT01497808 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01497808 about?
NCT01497808 is a clinical study titled "Radvax™: A Stratified Phase I/II Dose Escalation Trial OF Hypofractionated Radiotherapy Followed BY Ipilimumab IN Metastatic Melanoma". The primary objective is to determine the maximum tolerated hypofractionated radiotherapy dose (MTD) to a solitary metastatic focus ('index lesion') when followed by ipilimumab, in metastatic melanoma patients without brain involvement The secondary objectives are to determine late toxicity, immune-...
What is the current status of trial NCT01497808?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2011-11-29. Estimated completion is 2015-10-12.
What interventions are being tested in trial NCT01497808?
The interventions under investigation include: Stereotactic Body Radiation Therapy (RADIATION), Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT01497808?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
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