RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
Phase 1
Completed
- Conditions
- Metastatic Melanoma
- Interventions
- Radiation: Stereotactic Body Radiation Therapy
- Registration Number
- NCT01497808
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Ipilimumab and Radiotherapy (8 Gy x 3) Ipilimumab - Ipilimumab and Radiotherapy (8 Gy x 2) Stereotactic Body Radiation Therapy - Ipilimumab and Radiotherapy (6 Gy x 2) Stereotactic Body Radiation Therapy - Ipilimumab and Radiotherapy (6 Gy x 3) Stereotactic Body Radiation Therapy - Ipilimumab and Radiotherapy (8 Gy x 2) Ipilimumab - Ipilimumab and Radiotherapy (8 Gy x 3) Stereotactic Body Radiation Therapy - Ipilimumab and Radiotherapy (6 Gy x 2) Ipilimumab - Ipilimumab and Radiotherapy (6 Gy x 3) Ipilimumab -
- Primary Outcome Measures
Name Time Method Dose-limiting Toxicity (DLT) 30 days
- Secondary Outcome Measures
Name Time Method Participants With Adverse Events after 30 days
Trial Locations
- Locations (1)
Abramson Cancer Center of the Universirty of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States