viernes, 8 de julio de 2016

NCT02667587 Clinical Trial - National Cancer Institute || Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer).

NCT02667587 Clinical Trial - National Cancer Institute

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

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IITreatmentActive18 and overCA209-548
NCI-2016-00952, 2015-004722-34, NCT02667587

Trial Description

Summary

The main purpose of this study is to compare how long patients with glioblastoma (GBM, a
malignant brain cancer) live after receiving temozolomide plus radiation therapy compared
with patients receiving nivolumab in addition to temozolomide plus radiation therapy.

Eligibility Criteria

Inclusion Criteria:
Males and Females, age ≥ 18 years old
Newly diagnosed brain cancer or tumor called glioblastoma or GBM
Karnofsky performance status of ≥ 70 (able to take care of self)
Full recovery from surgical resection
Tumor test result shows MGMT methylated, partially methylated, or indeterminate tumor
subtype
Exclusion Criteria:
Biopsy-only of GBM with less than 20% of tumor removed
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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Bristol-Myers Squibb

  • Ono Pharmaceutical Company Limited

Trial Sites

U.S.A.

Ohio
Cleveland
Case Comprehensive Cancer Center
Manmeet Singh Ahluwalia
Ph: 866-223-8100
Email: ahluwam@ccf.org
Manmeet Singh Ahluwalia
Principal Investigator
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.

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