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Closed (no longer recruiting)Last updated: 7 February 2024

Checkmate 548: This phase II trial is comparing outcomes for patients with newly diagnosed Glioblastoma who receive temozolomide plus radiation therapy, with patients who also receive nivolumabA Randomized Phase 2 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

Clinical summary

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. **Tumor test result shows MGMT methylated, partially methylated, or indeterminate tumor subtype**

Conditions

This trial is treating patients with Glioblastoma.

Cancer

Brain and Spinal Cancers Brain and Spinal

Age

People18+

Phase

II

Trial Acronym

Checkmate 548

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Randomized Phase 2 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

Eligibility

Inclusion

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

  • 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)
  • Substantial recovery from surgery resection
  • Tumor test result shows MGMT methylated or indeterminate tumor subtype

Exclusion

  • 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

Other protocol defined inclusion/exclusion criteria could apply

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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