Nivo/Ipi Combination Therapy in Symptomatic Brain Metastases

Sponsor
University Medical Center Groningen
Study ID
NCT02621515
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2016
Status verified
May 2024
Primary completion
May 30, 2018
Completion
May 30, 2018

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Nivolumab
    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demonstrated, if unacceptable toxicity or intercurrent illness prevents further treatment, and when informed consent is withdrawn.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

Primary Outcome Measure

The best overall response rate (BORR) of brain metastases to nivolumab will be assessed on Magnetic Resonance Imaging (MRI) using the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. [ Time Frame: 2 years ]

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