Neoadjuvant Nivolumab in Glioblastoma

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Study ID
NCT02550249
Phase
PHASE2
Status
Completed

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Intravenous administration of nivolumab

Study Details

Neoadjuvant nivolumab will be administered to patients with primary and recurrent glioblastoma multiforme that require surgery. Nivolumab will be continued following surgery.

Key Dates

Start date
Jun 30, 2015
Status verified
Jul 2015
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017

Study Design

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

Arms

  • Experimental: Nivolumab
    Nivolumab 3 mg every 2 weeks

Primary Outcome Measure

Changes in percentage and level of expression of Programmed Death-Ligand 1 (PD-L1) by tumor cells and lymphocytes, assessed at baseline and following neoadjuvant nivolumab in Glioblastoma multiforme (GBM). [ Time Frame: 1 neoadjuvant cycle followed by surgery (4 weeks). Evaluation will be performed at baseline and after the neoadjuvant cycle ]

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