Phase 3 Brain Cancer Trial, Completed NCT02617589 Sponsor: Bristol-Myers Squibb Condition: Brain Cancer
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 560 adults with a type of brain tumour, with 280 randomly assigned to receive nivolumab (an immunotherapy drug) combined with radiation therapy, and 280 assigned to receive temozolomide (a chemotherapy drug) combined with radiation therapy. The trial's main goal was to measure overall survival — that is, how long participants lived after joining the study. The reported data shows that, for the primary measure of overall survival, the median time (the point at which half the participants had died and half were still alive) was approximately 13.4 months in the nivolumab plus radiation group, compared with approximately 14.9 months in the temozolomide plus radiation group. For a secondary measure — how long participants lived without their disease getting worse (called progression-free survival) — the reported median was about 6.0 months in the nivolumab group and 6.2 months in the temozolomide group. The reported data also shows that at the two-year mark, approximately 10.6% of participants in the nivolumab group and 21.2% in the temozolomide group were estimated to still be alive. For two additional secondary measures looking at outcomes specifically in participants whose tumours had a high number of genetic changes (known as "tumour mutational burden high"), no numerical results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Brain Cancer Trial, Completed

NCT02617589
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years old or older (male or female)
  • You have been recently diagnosed with a type of brain cancer called glioblastoma (also known as GBM)
  • Your tumor test results show a specific characteristic called "MGMT unmethylated" (confirm with trial site if unsure of your results)
  • You are able to take care of yourself and carry out normal daily activities (your doctor will assess this)

Who may not be able to join:

  • You have already received treatment for GBM, not counting surgery to remove the tumor
  • You have any known cancer or tumor located outside of the brain
  • Your GBM has come back after previous treatment, or developed as a result of another cancer
  • You have an active autoimmune disease (a condition where your immune system attacks your own body)
  • Your surgery only removed less than 20% of the tumor during biopsy
  • There may be additional requirements not listed here that the trial team will check

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb

Australian sites

Royal North Shore Hospital, St Leonards, New South Wales
Local Institution - 0003, Heidelberg, Victoria
Local Institution - 0004, Prahran, Victoria
Local Institution - 0001, Nedlands, Western Australia
Local Institution - 0002, New South Wales,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 March 2016
Est. completion
17 January 2019

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇷🇺 Russia 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Overall Survival (OS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov