drugset / Trial / NCT02054520

Immunotherapy Study for Patients With Stage IV Melanoma

NCT02054520 ↗

Phase 2 Terminated 47 enrolled NewLink Genetics Corporation
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to examine the effectiveness of immune checkpoint inhibitors (drugs called ipilimumab, nivolumab, or pembrolizumab), either given alone, or in combination with the experimental immunotherapy drug, dorgenmeltucel-L, for melanoma. We hypothesize that this form of combinatorial immunotherapy will result in tumor stabilization or shrinkage, significant prolongation of progression-free, disease-free or overall survival compared to the use of immune checkpoint inhibitors alone.

Timeline

Start
2014-06
Primary completion
2018-04-05
Completion
2021-01-05

Outcome

Outcome not reported

Stopped: “Withdrawal of IND”

Drugs

EvaluationDrugModalityDoseRoute
Subject Dorgenmeltucel-L Vaccine 3e+08 cells —
Subject Ipilimumab Monoclonal antibody 3 mg/kg —
Subject Nivolumab Monoclonal antibody 3 mg/kg —
Subject Pembrolizumab Monoclonal antibody 2 mg/kg —

Indications