drugset / Trial / NCT03728465

Evaluation of Safety and Efficacy of Patients With Four and More Symptomatic Brain Metastases of Melanoma

NCT03728465 ↗

Phase 2 Terminated 6 enrolled University Hospital Tuebingen
NaSingle-groupOpen-labelTreatment

Summary

Up to 50% of patients with unresectable metastatic melanoma will develop brain metastases during their lifetime. A possible treatment options for patients with brain metastases are surgery and radiotherapy but usually for lesions in the range of \< 3 brain metastases. This study was performed to evaluate the addition of immune checkpoint inhibitors in patients with stage IV melanoma with \> 3 symptomatic brain metastases, who are not eligible for surgery or radiosurgery.

Timeline

Start
2018-04-10
Primary completion
2021-01-01
Completion
2021-01-01

Outcome

Outcome not reported

Stopped: “Lack of patients”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 3 mg/kg Intravenous