NCT02621515

Nivo/Ipi Combination Therapy in Symptomatic Brain Metastases

An Open-label, Single-arm, Phase II, Multicenter Study to Evaluate the Efficacy of Nivolumab/Ipilimumab Combination Therapy in Metastatic Melanoma Patients With Symptomatic Brain Metastases.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is an open label, single arm, phase II clinical trial of prospectively collected data evaluating efficacy and safety of nivolumab in metastatic melanoma patients with symptomatic brain metastases. It will be conducted in several study centers in the Netherlands. Patients with radiologic evidence of brain metastases and who are eligible for treatment with nivolumab will be screened for inclusion. All patients in this trial will receive treatment with nivolumab for 24 months. Treatment will be discontinued if confirmed disease progression has been demonstrated, if unacceptable toxicity or intercurrent illness prevents further treatment, and when informed consent is withdrawn. After discontinuation of treatment, follow-up will start. Duration of follow-up depends on survival of patients, with a maximum of 24 months. Therefore the end of this study is determined as 24 months after the last patient in this trial has started follow-up, has died, withdraws consent or is lost to follow-up for a different reason.

Conditions

• Melanoma
• Brain Metastasis

Interventions

Type	Name	Description
DRUG	Nivolumab	All patients in this phase 2 trial will receive treatment with nivolumab, a monoclonal antibody against the PD1-receptor on T cells. Dosing will be based on patients' weight (3 mg/kg). It will be administered in an intravenous infusion every 2 weeks and for a maximum of 2 years.

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2015-12-03
• Last updated: 2024-05-06

Locations

4 sites across 1 country: Netherlands