Phase 2
N=22
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
Metastatic Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01497808 ↗Enrolled (actual)
22
Serious AEs
50.0%
Results posted
Aug 2021
Primary outcome: Primary: Dose-limiting Toxicity (DLT) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ipilimumab (Drug); Stereotactic Body Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose-limiting Toxicity (DLT) |
0; 0; 0; 0 | — |
| SECONDARY Participants With Adverse Events |
6; 4; 6; 6 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01497808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.