CompletedPhase 1 / Phase 2NCT01497808

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

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

Checked against the public recordLast updated Aug 10, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations1
SponsorAbramson Cancer Center at Penn Medicine
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Abramson Cancer Center at Penn Medicine
Interventions being studied
Drug: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Abramson Cancer Center of the Universirty of PennsylvaniaPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 10, 2021. Always confirm current availability with the study team.

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