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

• Status: Completed
• Trial end date: 2015-10-12
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Antibodies, Monoclonal; Ipilimumab

Criteria

Inclusion Criteria

• Patient > 18 years old

• Histologically confirmed diagnosis of melanoma

• Previously treated or previously untreated metastatic melanoma by AJCC staging criteria

• Presence of an index lesion > 1 cm amenable to hypofractionated radiotherapy and at least one other additional lesion that can be followed for response using RECIST criteria

• ECOG Performance status 0 or 1

• Signed informed consent document

• Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold position for treatment)

Exclusion Criteria

• Prior systemic therapy within 14 days of study enrollment. Patients must be adequately recovered from prior systemic therapy side effects as deemed by the PI.

• Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc)

• Presence or history of central nervous system metastasis (including brain)

• Long-term use of systemic corticosteroids

• Prior RT that precludes the delivery of hypofractionated radiotherapy