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You will receive

Study-related treatment at no cost


To qualify, you must be

Male or Female

18 +

Years Old


This is where the study procedures will take place

Travel expenses may be reimbursed


Showing 3 of 126 available location(s)
Beaston West of Scotland Cancer Centre Claim this site

Recruiting United Kingdom, Glasgow

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Recruiting Canada, Vancouver British Columbia

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Recruiting Germany, Tuebingen

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Recruiting United Kingdom, London Greater London

University Hospital Geneva Claim this site

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University of Alabama at Birmingham Claim this site

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University of Kansas Medical Center Claim this site

Recruiting United States, Westwood Kansas

University of Texas Southwestern Medical Center Claim this site

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UZ Leuven Claim this site

Recruiting Belgium, Leuven

Vanderbilt University Medical Center Claim this site

Recruiting United States, Nashville Tennessee

Washington University School of Medicine Claim this site

Recruiting United States, Saint Louis Missouri

Yale University School of Medicine Claim this site

Recruiting United States, New Haven Connecticut

Study Details

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Study Conditions

About This Condition


Who can participate?

Ideal candidates should meet the following criteria

  • Tumor test result shows MGMT methylated or indeterminate tumor subtype
  • Substantial recovery from surgery resection
  • Karnofsky performance status of ≥ 70 (able to take care of self)
  • Newly diagnosed brain cancer or tumor called glioblastoma or GBM
  • Males and Females, age ≥ 18 years old

Reasons you may not be a good fit

  • Prior treatment for GBM (other than surgical resection)
  • Recurrent or secondary GBM
  • Biopsy-only of GBM with less than 20% of tumor removed
  • Active known or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria could apply
  • Any known tumor outside of the brain


About This Study

Name

An Investigational Immuno therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

Status

Recruiting

ID

NCT02667587

Phase

Phase 3

Type

Interventional

Summary

A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma

Purpose

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving Nivolumab in addition to temozolomide plus radiation therapy.

Details

No addtional details have been provided. click here to stay informed


Study Interventions

Investigational product(s)

Temozolomide


Nivolumab


Procedure(s)

Radiotherapy


Other(s)

Nivolumab placebo



What will be monitored/measured (Outcomes)

Overall survival (OS) defined as time from the date of randomization to the date of death.

Approximately 69 months after first patient first visit


Progression free survival (PFS), defined as the time from randomization to the date of the first documented tumor progression or death to any cause.

Approximately 69 months after first patient first visit


Correlation of PFS and OS

Approximately 69 months after first patient first visit



This Study is Sponsored By


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This study is also collaborated by


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