drugset / Trial / NCT01856023
HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma
Phase 4
Terminated
29 enrolled
Clinigen, Inc.
Johns Hopkins University · collabM.D. Anderson Cancer Center · collab
RandomizedSequentialOpen-labelTreatment
Summary
Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic melanoma who are treatment naïve or have previously received a single non-immunologic therapy. Treatment Arm 1: "HD IL-2 first, then ipilimumab" Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab. Treatment Arm 2: Ipilimumab first then HD IL-2 Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.
Timeline
- Start
- 2013-05
- Primary completion
- 2015-07
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Comparator | aldesleukin | Protein / enzyme biologic | 600000 iu/kg | Intravenous |