drugset / Trial / NCT02748564

Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma

NCT02748564 ↗

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

EvaluationDrugModalityDoseRoute
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