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|NCT01497808 : RADVAX: A Stratified Phase I/II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma|
|Phase||Phase 1/Phase 2|
|Ages||Min: 18 Years Max: N/A|
- Patients aged 18 years and older.
- Histologically confirmed diagnosis of melanoma
- Previously treated or previously untreated stage IV melanoma by AJCC staging criteria
- Presence of an index lesion between 1 cm and 5 cm.
- EGOC performance status 0 to 1
- Signed informed consent document.
- Adequate renal, hepatic, and hematologic indices for ipilimumab therapy
- Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold
position for treatment)
- Prior systemic therapy within 28 days of study enrollment
- Clinical contraindication to stereotactic body radiotherapy (e.g.active systemic
sclerosis, active inflammatory bowel disease if bowel is within target field, etc)
- Previous treatment with antiCTLA-4 antibody or cancer vaccine
- Presence or history of central nervous system metastasis (including brain)
- Long-term use of systemic corticosteroids
- Prior RT within 2 months of study entry
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01497808
| Link to official Clinicaltrials.gov listing