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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

Official Title

A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)

Keywords

Brain Cancer Temozolomide Dacarbazine Nivolumab Antibodies, Monoclonal

Eligibility

For people ages 18 years and up

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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)

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

Locations

  • Sutter Medical Group in progress, not accepting new patients
    Sacramento, California, 95816, United States
  • Cedars-Sinai Medical Center completed
    Los Angeles, California, 90048, United States
  • Ucla Neuro-Oncology Program in progress, not accepting new patients
    Los Angeles, California, 90095, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS clinical trial educational resource
Investigator Inquiry form
FDA Safety Alerts and Recalls
ID
NCT02617589
Phase
Phase 3
Lead Scientist
Nicholas Butowski
Study Type
Interventional
Last Updated
April 1, 2017