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

Sponsor
University Hospital Tuebingen
Study ID
NCT03728465
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    In the induction phase of this study nivolumab is administered as a IV infusion in combination with ipilimumab at a dose of 1 mg/kg for 4 cycles at three weeks interval and in a maintenance phase alone at a dose of 3 mg/kg every two weeks.
  • Ipilimumab — BIOLOGICAL
    In the induction phase of this study ipilimumab is administered as a IV infusion in combination with nivolumab at a dose of 3 mg/kg for 4 cycles at three weeks interval.

Study Details

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.

Key Dates

Start date
Apr 10, 2018
Status verified
Oct 2018
Primary completion
Jan 1, 2021
Completion
Jan 1, 2021

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Phase
    Treatment phase is divided into the "Induction Phase" and "Maintenance Phase". During the induction phase patients are treated with 1 mg/kg nivolumab and 3 mg/kg ipilimumab, during the maintenance phase with nivolumab 3 mg/kg only .

Primary Outcome Measure

Intracranial Control Rate after 6 months of treatment [ Time Frame: 6 months ]

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