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

Abramson Cancer Center at Penn Medicine

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Melanoma

Treatments: Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01497808

UPCC 06611

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 4 patient groups

Ipilimumab and Radiotherapy (8 Gy x 2)

Experimental group

Treatment:

Drug: Ipilimumab

Radiation: Stereotactic Body Radiation Therapy

Ipilimumab and Radiotherapy (8 Gy x 3)

Experimental group

Treatment:

Drug: Ipilimumab

Radiation: Stereotactic Body Radiation Therapy

Ipilimumab and Radiotherapy (6 Gy x 2)

Experimental group

Treatment:

Drug: Ipilimumab

Radiation: Stereotactic Body Radiation Therapy

Ipilimumab and Radiotherapy (6 Gy x 3)

Experimental group

Treatment:

Drug: Ipilimumab

Radiation: Stereotactic Body Radiation Therapy