Study of Nivolumab versus Temozolomide, given with radiation therapy, for newly-diagnosed patients with glioblastoma (GBM, a malignant brain cancer)

Conditions: nmethylated MGMT (tumor O-6-methylguanine DNA methyltransferase) Glioblastoma
MedDRA version: 18.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-003739-37-ES

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 640

Inclusion Criteria

Males and Females, age ? 18 years old
Newly-diagnosed brain cancer or tumor called glioblastoma or GBM
Tumor test result shows MGMT unmethylated type
Karnofsky performance status of ? 70 (able to care for self)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 512
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 128

Exclusion Criteria

Prior treatment for GBM (other than surgical resection)
Any known tumor outside of the brain
Recurrent or secondary GBM
Active known or suspected autoimmune disease
Biopsy with less than 20% of tumor removed

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main purpose of this study is to compare how long patients with glioblastoma (GBM, a malignant brain cancer) live after receiving nivolumab every two weeks in addition to radiation therapy (RT), and then every four weeks, compared with patients receiving standard therapy with temozolomide in addition to RT;Secondary Objective: - To compare investigator-assessed progression-free survival (PFS) of RT + nivolumab versus RT + TMZ;<br>- To estimate the overall survival rate at 24 months (OS[24]) of RT + nivolumab versus RT + TMZ (final analysis only);Primary end point(s): Overall survival of nivolumab versus temozolomide both in combination with radiation therapy;Timepoint(s) of evaluation of this end point: Time between the date of randomization and the date of death due to any cause

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Progression free survival<br>- Overall survival rate of nivolumab versus temozolomide both in combination with radiation therapy;Timepoint(s) of evaluation of this end point: - Time from randomization to date of first documented tumor progression or death due to any cause<br>- 24 months