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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: Completed Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.

NCT01497808 is a Phase 1 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 22 participants
Start Date 2011-11-29
Est. Completion 2015-10-12
Phase Phase 1

What the finished NCT01497808 record still lists

NCT01497808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 2 interventions - of which Stereotactic Body Radiation Therapy is the first listed.

NCT01497808 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01497808's enrollment target sits among peer trials

22 1601st of 2000 higher than 386 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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Source: ClinicalTrials.gov NCT01497808, the US trial registry maintained by the National Library of Medicine. NCT01497808 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.