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
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
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 Carolina | 100.0% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| Levine Cancer Institute | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
References
- Woroniecka, Karolina, and Peter E Fecci. 2020. “Immuno-synergy? Neoantigen Vaccines and Checkpoint Blockade in Glioblastoma”. Neuro-oncology. Oxford University Press (OUP). doi:10.1093/neuonc/noaa170.
- Lim, Michael, Michael Weller, Ahmed Idbaih, Joachim Steinbach, Gaetano Finocchiaro, Raju R Raval, George Ansstas, et al.. 2022. “Phase III Trial of Chemoradiotherapy with Temozolomide Plus Nivolumab or Placebo for Newly Diagnosed Glioblastoma with Methylated mgmt Promoter”. Neuro-oncology. Oxford University Press (OUP). doi:10.1093/neuonc/noac116.
- Lim M, Weller M, Idbaih A, Steinbach J, Finocchiaro G, Raval RR, Ansstas G, Baehring J, Taylor JW, Honnorat J, Petrecca K, De Vos F, Wick A, Sumrall A, Sahebjam S, Mellinghoff IK, Kinoshita M, Roberts M, Slepetis R, Warad D, Leung D, Lee M, Reardon DA, Omuro A. Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro Oncol. 2022 Nov 2;24(11):1935-1949. doi: 10.1093/neuonc/noac116.
- Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.
- 2016. "An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02667587.
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Conditions
Cancer Related
Treatments