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

July 19, 2021 updated by: Abramson Cancer Center of the University of Pennsylvania
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the Universirty of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Participants With Adverse Events
Time Frame: after 30 days
after 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Amit Maity, PhD, Abramson Cancer Center of the University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2011

Primary Completion (Actual)

December 29, 2013

Study Completion (Actual)

October 12, 2015

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 23, 2011

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 06611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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