Back to resultsRADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
Primary Purpose
Metastatic Melanoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ipilimumab
Stereotactic Body Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Melanoma focused on measuring previously untreated, previously treated, bone, lung, liver or subcutaneous involvement, nodal involvement, without evidence of brain involvement
Eligibility 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
Sites / Locations
- Abramson Cancer Center of the Universirty of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Ipilimumab and Radiotherapy (8 Gy x 2)
Ipilimumab and Radiotherapy (8 Gy x 3)
Ipilimumab and Radiotherapy (6 Gy x 2)
Ipilimumab and Radiotherapy (6 Gy x 3)
Arm Description
Outcomes
Primary Outcome Measures
Dose-limiting Toxicity (DLT)
Secondary Outcome Measures
Participants With Adverse Events
Full Information
NCT ID
NCT01497808
First Posted
December 13, 2011
Last Updated
July 19, 2021
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01497808
Brief Title
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
Official Title
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 29, 2011 (Actual)
Primary Completion Date
December 29, 2013 (Actual)
Study Completion Date
October 12, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
previously untreated, previously treated, bone, lung, liver or subcutaneous involvement, nodal involvement, without evidence of brain involvement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ipilimumab and Radiotherapy (8 Gy x 2)
Arm Type
Experimental
Arm Title
Ipilimumab and Radiotherapy (8 Gy x 3)
Arm Type
Experimental
Arm Title
Ipilimumab and Radiotherapy (6 Gy x 2)
Arm Type
Experimental
Arm Title
Ipilimumab and Radiotherapy (6 Gy x 3)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Primary Outcome Measure Information:
Title
Dose-limiting Toxicity (DLT)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Participants With Adverse Events
Time Frame
after 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Maity, PhD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the Universirty of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33643689
Citation
Maity A, Mick R, Rengan R, Mitchell TC, Amaravadi RK, Schuchter LM, Pryma DA, Patsch DM, Maity AP, Minn AJ, Vonderheide RH, Lukens JN. A stratified phase I dose escalation trial of hypofractionated radiotherapy followed by ipilimumab in metastatic melanoma: long-term follow-up and final outcomes. Oncoimmunology. 2021 Jan 31;10(1):1863631. doi: 10.1080/2162402X.2020.1863631.
Results Reference
derived
Learn more about this trial
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
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