drugset / Trial / NCT02748564
Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma
Phase 2
Terminated
10 enrolled
Rutgers, The State University of New Jersey
National Cancer Institute (NCI) · collab
NaSequentialOpen-labelTreatment
Summary
This study will evaluate the safety and tolerability of IL-2 when given in combination with pembrolizumab to patients with advanced melanoma. Aldesleukin may stimulate white blood cells to melanoma cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving aldesleukin and pembrolizumab may kill more tumor cells. There are two parts to this study: * Phase Ib: To determine the safety and side effects of increasing doses of IL-2 in combination with pembrolizumab * Phase II: Once the maximum tolerated dose of IL-2 is determined, additional patients will be treated to determine if it is effective against the cancer.
Timeline
- Start
- 2017-03-21
- Primary completion
- 2018-10-18
- Completion
- 2023-06-05
Outcome
Outcome not reported
Stopped: “Study Complete”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | aldesleukin | Protein / enzyme biologic | 6000 iu/kg | Intravenous |
| Subject | aldesleukin | Protein / enzyme biologic | 60000 iu/kg | Intravenous |
| Subject | aldesleukin | Protein / enzyme biologic | 600000 iu/kg | Intravenous |