Clinical Trial: NCT02617589 - My Cancer Genome

NCT02617589

Description:

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.

Related Conditions:

Glioblastoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02617589

Trial Eligibility

Document

Title

Brief Title: 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)
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)

Clinical Trial IDs

ORG STUDY ID: CA209-498
SECONDARY ID: 2015-003739-37
NCT ID: NCT02617589

Conditions

Brain Cancer

Interventions

Drug	Synonyms	Arms
Nivolumab		Nivolumab + Radiotherapy Arm
Temozolomide		Temozolomide + Radiotherapy Arm

Purpose

Trial Arms

Name	Type	Description	Interventions
Nivolumab + Radiotherapy Arm	Experimental	Nivolumab IV infusion + Radiotherapy dose as specified	Nivolumab
Temozolomide + Radiotherapy Arm	Active Comparator	Temozolomide + Radiotherapy dose as specified	Temozolomide

Eligibility 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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Overall Survival (OS)
Time Frame:	up to 3 years
Safety Issue:
Description:	OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.

Secondary Outcome Measures

Measure:	Progression Free Survival (PFS)
Time Frame:	up to 3 years
Safety Issue:
Description:	PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die will be censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment will be censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on RANO criteria

Measure:	OS at 24 Months
Time Frame:	at 24 Months
Safety Issue:
Description:	The OS rate at 24 months of nivolumab + RT and RT + TMZ was estimated as Kaplan-Meier probability of survival at 24 months.

Measure:	OS in Tumor Mutational Burden (TMB) High Population
Time Frame:	up to 3 years
Safety Issue:
Description:	OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.

Measure:	PFS in Tumor Mutational Burden (TMB) High Population
Time Frame:	up to 3 years
Safety Issue:
Description:	PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die will be censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment will be censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on RANO criteria

Details

Phase:	Phase 3
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Bristol-Myers Squibb

Last Updated

February 3, 2021

Clinical Trials /

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)