At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
Ipilimumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
In Brief
A Phase 2 clinical trial evaluating Ipilimumab and Stereotactic Body Radiation Therapy for Metastatic Melanoma. Completed, enrolled 22 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Melanoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedDec 2011
Primary CompletionDec 2013
Study CompletionOct 2015
TodayJul 2026
First PostedDec 23, 2011
Enrollment StartNov 29, 2011
Primary CompletionDec 29, 2013
Study CompletionOct 12, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.5 years ago
Interventions
Ipilimumabdrug
Stereotactic Body Radiation Therapyradiation