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

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Melanoma

In brief

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

Key facts

Study ID

NCT01497808

Run by

Abramson Cancer Center at Penn Medicine

People needed

22

Starts

2011-11-29

Expected to finish

2015-10-12

Last updated by the study team

2021-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Abramson Cancer Center of the Universirty of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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