Nivolumab for Brain Tumors

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Brain TumorsNivolumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding the immunotherapy drug nivolumab to standard treatment for glioblastoma improves outcomes.

Eligible Conditions
  • Brain Tumors

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: From randomization to date of death (up to approximately 4.5 years)

Month 35
Progression free survival (PFS), investigator assessed
Progression-free survival (PFS), Blinded Independent Central Review (BICR) assessed
Month 69
Overall survival (OS) defined as time from the date of randomization to the date of death.
Month 12
Overall Survival (OS) Rates at 12 Months
Month 24
Overall Survival (OS) Rates at 24 Months
Year 5
Overall Survival (OS)
Year 5
Progression Free Survival (PFS) Based on Investigator Assessment
Progression-free Survival (PFS) Determined by BICR

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Nivolumab + Temozolomide + Radiotherapy
1 of 2
Nivolumab placebo + Temozolomide + Radiotherapy
1 of 2

Experimental Treatment

Non-Treatment Group

716 Total Participants · 2 Treatment Groups

Primary Treatment: Nivolumab · Has Placebo Group · Phase 3

Nivolumab + Temozolomide + RadiotherapyExperimental Group · 3 Interventions: Temozolomide, Nivolumab, Radiotherapy · Intervention Types: Drug, Drug, Radiation
Nivolumab placebo + Temozolomide + RadiotherapyPlaceboComparator Group · 3 Interventions: Temozolomide, Radiotherapy, Nivolumab Placebo · Intervention Types: Drug, Radiation, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
FDA approved
Nivolumab
FDA approved
Radiotherapy
2017
Completed Phase 3
~2600

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization to date of death (up to approximately 4.5 years)

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdIndustry Sponsor
149 Previous Clinical Trials
94,024 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,501 Previous Clinical Trials
3,927,552 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The tumor is MGMT methylated or indeterminate.
You are able to take care of yourself.
You have been diagnosed with a newly diagnosed brain tumor called glioblastoma or GBM.

Who else is applying?

What state do they live in?
North Carolina100.0%
How old are they?
65+100.0%
What site did they apply to?
Levine Cancer Institute100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References