Clinical trial · Interventional
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
NCT01497808CI-TRIAL-00053182completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Ipilimumab and Radiotherapy (8 Gy x 2)
- interventionNames
- Drug: Ipilimumab
- Radiation: Stereotactic Body Radiation Therapy
- type
- EXPERIMENTAL
- label
- Ipilimumab and Radiotherapy (8 Gy x 3)
- interventionNames
- Drug: Ipilimumab
- Radiation: Stereotactic Body Radiation Therapy
- type
- EXPERIMENTAL
- label
- Ipilimumab and Radiotherapy (6 Gy x 2)
- interventionNames
- Drug: Ipilimumab
- Radiation: Stereotactic Body Radiation Therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMaity 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. PMID 33643689