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

Study Overview
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Brief Summary
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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

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

Conditions
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Metastatic Melanoma

Intervention / Treatment
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* Drug: Ipilimumab
* Radiation: Stereotactic Body Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ipilimumab and Radiotherapy (8 Gy x 2)<br> | Drug: Ipilimumab<br> <br> Radiation: Stereotactic Body Radiation Therapy<br> <br> |
| Experimental: Ipilimumab and Radiotherapy (8 Gy x 3)<br> | Drug: Ipilimumab<br> <br> Radiation: Stereotactic Body Radiation Therapy<br> <br> |
| Experimental: Ipilimumab and Radiotherapy (6 Gy x 2)<br> | Drug: Ipilimumab<br> <br> Radiation: Stereotactic Body Radiation Therapy<br> <br> |
| Experimental: Ipilimumab and Radiotherapy (6 Gy x 3)<br> | Drug: Ipilimumab<br> <br> Radiation: Stereotactic Body Radiation Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting Toxicity (DLT) |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Adverse Events |  | after 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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without evidence of brain involvement, previously untreated, previously treated, bone, lung, liver or subcutaneous involvement, nodal involvement