Nivo/Ipi Combination Therapy in Symptomatic Brain Metastases
Summary
The effect of nivolumab on symptomatic brain metastases is currently unknown. This phase 2 clinical trial will be the first to evaluate this intracranial effect in humans, with the aim to give these patients the possibility to be treated with anti-PD-1. Besides the objective response rate, long term benefits in this patient category will be evaluated by measuring survival in terms of progression free survival and overall survival. Furthermore safety and tolerability of administration of this drug in patients with symptomatic brain metastases will be studied, as this is the first study for nivolumab in this specific patient category.
Timeline
- Start
- 2016-08
- Primary completion
- 2018-05-30
- Completion
- 2018-05-30
Outcome
Outcome not reported
Stopped: “In the Netherlands we wanted to add pilimumab to nivolumab. This resulted in a very long METC procedure which resulted in a to slow inclusion rate.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |