An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (CheckMate 498)
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| ClinicalTrials.gov Identifier: NCT02617589 |
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Recruitment Status :
Active, not recruiting
First Posted : December 1, 2015
Last Update Posted : October 20, 2020
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief Summary:
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain Cancer | Drug: Nivolumab Drug: Temozolomide Radiation: Radiotherapy | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 550 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498) |
| Actual Study Start Date : | January 30, 2016 |
| Actual Primary Completion Date : | January 17, 2019 |
| Estimated Study Completion Date : | August 31, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Brain Tumors
| Arm | Intervention/treatment |
|---|---|
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Experimental: Nivolumab + Radiotherapy Arm
Nivolumab IV infusion + Radiotherapy dose as specified
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Drug: Nivolumab Radiation: Radiotherapy |
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Active Comparator: Temozolomide + Radiotherapy Arm
Temozolomide + Radiotherapy dose as specified
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Drug: Temozolomide Radiation: Radiotherapy |
Primary Outcome Measures :
- Overall survival (OS) [ Time Frame: Approximately 3 years ]Overall survival: Defined as the time between the date of randomization and the date of death due to any cause
Secondary Outcome Measures :
- Progression free survival (PFS) [ Time Frame: Approximately 24 months ]Progression free survival: Defined as the time from randomization to the date of the first documented tumor progression or death due to any cause
- Overall survival [ Time Frame: Approximately 24 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Males and Females, age ≥ 18 years old
- Newly-diagnosed brain cancer or tumor called glioblastoma or GBM
- Tumor test result shows MGMT unmethylated type
- Karnofsky performance status of ≥ 70 (able to care for self)
Exclusion Criteria:
- 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
- Biopsy with less than 20% of tumor removed
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617589
Locations
Show 125 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02617589 |
| Other Study ID Numbers: |
CA209-498 2015-003739-37 ( EudraCT Number ) |
| First Posted: | December 1, 2015 Key Record Dates |
| Last Update Posted: | October 20, 2020 |
| Last Verified: | October 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Glioblastoma Brain Neoplasms Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms |
Neoplasms by Site Brain Diseases Astrocytoma Central Nervous System Diseases Nervous System Diseases Nivolumab Temozolomide Antineoplastic Agents, Immunological Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |