A Phase 3 Study of ONO-4538/BMS-936558(ONO-4538-40/CA209548)

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(ONO-4538-40/CA209548)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223128

Enrollment

693

Registered

2016-03-03

Start date

2016-05-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Interventions

investigational material(s) Generic name etc : ONO-4538/BMS-936558 INN of investigational material : nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Inve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newly-diagnosed GBM 2. Tumor test result shows MGMT methylated or indeterminate tumor subtype 3. Karnofsky performance status of >= 70 (able to care for self) 4. Substantial recovery from surgical resection

Exclusion criteria

Exclusion criteria: 1. Biopsy-only of GBM with less than 20% of tumor removed 2. Prior treatment for GBM (other than surgical resection) 3. Any known tumor outside of the brain 4. Recurrent or secondary GBM 5. Active known or suspected autoimmune disease

Design outcomes

Primary

Measure	Time frame
efficacy Progression free survival (PFS), Blinded Independent Central Review(BICR) assessed, Overall survival (OS)	—

Secondary

Measure	Time frame
efficacy Overall survival rate at 24 months (OS[24]), Progression free survival (PFS), Investigator assessed	—

Countries

Europe, Japan, Middle East, North America, Oceania

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026