NCT01497808

RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Ipilimumab
RADIATION	Stereotactic Body Radiation Therapy

Timeline

• Start date: 2011-11-29
• Primary completion: 2013-12-29
• Completion: 2015-10-12
• First posted: 2011-12-23
• Last updated: 2021-08-10
• Results posted: 2021-08-10

Locations

1 site across 1 country: United States