Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
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|ClinicalTrials.gov Identifier: NCT03718767|
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : September 28, 2022
Gliomas are the most common malignant brain tumors. Some have certain changes (mutations) in the genes IDH1 or IDH2. If there are a high number of mutations in a tumor, it is called hypermutator phenotype (HMP). The drug nivolumab helps the immune system fight cancer. Researchers think it can be more effective in patients with IDH1 or IDH2 mutated gliomas with HMP. They will test gliomas with and without HMP.
To see if nivolumab stops tumor growth and prolongs the time that the tumor is controlled.
Adults 18 years or older with IDH1 or IDH2 mutated gliomas
Participants will be screened with:
Heart, blood, and pregnancy tests
Review of symptoms and activity levels
Brain magnetic resonance imaging (MRI). Participants will lie in a cylinder that takes pictures in a strong magnetic field.
Participants will get the study drug in 4-week cycles. They will get it through a small plastic tube in a vein (IV) on days 1 and 15 of cycles 1-4. For cycles 5-16, they will get it just on day 1.
On days 1 and 15 of each cycle, participants will repeat some or all screening tests.
After cycle 16, participants will have 3 follow-up visits over 100 days. They will answer health questions, have physical and neurological exams, and have blood tests. They may have a brain MRI.
Participants whose disease did not get worse but who finished the study drug within 1 year of treatment may have imaging studies every 8 weeks for up to 1 year.
Participants will be called or emailed every 6 months with questions about their health.
|Condition or disease||Intervention/treatment||Phase|
|Glioma Glioblastoma High Grage Glioma Low Grade Glioma Malignant Glioma||Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Evaluating Nivolumab In Patients With IDH-Mutant Gliomas With And Without Hypermutator Phenotype|
|Actual Study Start Date :||March 27, 2019|
|Estimated Primary Completion Date :||September 30, 2025|
|Estimated Study Completion Date :||February 27, 2026|
- 6-month progression free survival rate [ Time Frame: 6 months ]Proportion of patients that do not have progressive disease after 6 months
- Proportion of patients that have improvement in quality of life [ Time Frame: Study Calendar -last collection of QOL questioner. ]To longitudinally evaluate patient reported outcome measures using self-reported symptom severity and interference with daily activities using the MDASI-BT.
- Median amount of time subject survives after therapy and Proportion of patients that have progressive disease after 12 months [ Time Frame: 12 months and death ]To determine the 1-year progression free survival rate and overall survival in IDH-mutant gliomas patients with and without HMP in response to nivolumab treatment.
- Correlation between neoantigen burden of tumor and proportion of subjects that survive after 6 and 12 months [ Time Frame: 6 months and 12 months ]To determine whether the neoantigen burden in tumor prior to the treatment is correlated with treatment response.
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): NCT03718767
|Contact: NCI NOB Referral Group||(866) email@example.com|
|Contact: Jing Wu, M.D.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Jing Wu, M.D.||National Cancer Institute (NCI)|