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

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