Clinical trial · Interventional
Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma
RADVAX: A Stratified Phase II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma
NCT01970527CI-TRIAL-00043392terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Change in standard of care
Summary
Brief summary (as posted)
This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IV Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (stereotactic body radiotherapy, ipilimumab)
- description
- Patients undergo a total of 3 fractions of stereotactic body radiotherapy between days 1-13. Patients then receive ipilimumab IV every 3 weeks. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: Ipilimumab
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (4)
- measure
- Immune-related Clinical Response, Defined as Proportion of Patients Treated at the Maximum-tolerated Dose (MTD) Who Achieve Either a Complete or Partial Immune-related Response
- timeFrame
- Up to 60 days after last ipilimumab injection
- description
- Scored on a non-index lesion using immune-related response criteria according to immune-related Response Evaluation Criteria in Solid Tumors version 1.1. The number of immune-related responses will be tabled by stratum and SBRT fraction dose level. At the MTD, the immune-related response rate and 95% exact confidence interval will be estimated separately for previously untreated and previously treated metastatic patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of melanoma * Previously treated or previously untreated stage IV melanoma by American Joint Committee on Cancer (AJCC) staging criteria * Presence of an index lesion between 1 and 5 cm * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Signed informed consent document * Adequate renal, hepatic, and hematologic indices for ipilimumab therapy * 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 treating investigator * Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc) * Presence of central nervous system metastasis (including active brain metastasis); active brain metastasis would be defined as untreated brain metastases; if the brain metastases have received prior treatment (usually either with surgery or radiation), they are no longer active * Long-term use of systemic corticosteroids; patients with replacement steroids and not immunosuppressive steroids may enroll in the study * Prior radiation therapy (RT) that precludes the delivery of SBRT
References
Publications (0)
Data not yet available
No reference posted for this study.