Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03367715|
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : November 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|MGMT-unmethylated Glioblastoma (GBM) GBM||Drug: Nivolumab Drug: Ipilimumab Radiation: Radiation Therapy (RT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-label, Single Arm Trial of Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma|
|Actual Study Start Date :||February 7, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: Nivolumab + Ipilimumab + Short-course radiation therapy
within 6 weeks of the first diagnostic surgery for glioblastoma, all subjects will initiate study treatment on Day 1
study treatment on Day 1 with one dose of nivolumab 3 mg/kg
study treatment on Day 1 with one dose of ipilimumab 1mg/kg
Radiation: Radiation Therapy (RT)
total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.
- 1-yr OS [ Time Frame: 1 Year ]To determine the overall survival at 1 year (1-yr OS) of adults with newly diagnosed, MGMT unmethylated GBM administered nivolumab, ipilimumab and short course RT.
- 2-year Overall Survival (OS) [ Time Frame: 2 Years ]Survival rate is defined as the percent of people who survive a disease such as cancer for a specified amount of time.
- Median Overall Survival (OS) [ Time Frame: 36 Months ]Survival rate is defined as the percent of people who survive a disease such as cancer for a specified amount of time.
- Median Progression Free Survival (PFS) [ Time Frame: 36 Months ]The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
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): NCT03367715
|Contact: Zacharia Sawaged||2122634431||Zacharia.Sawaged@nyulangone.org|
|Contact: Hector Sevillano-Torres||212-731-6267||Hector.Sevillanoemail@example.com|
|United States, New York|
|New York University School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: Zacharia Sawaged 212-263-4431 Zacharia.Sawaged@nyulangone.org|
|Principal Investigator: Andrew Chi, MD|
|Principal Investigator: Sylvia Kurz, MD|
|Sub-Investigator: Erik Sulman, MD|
|Principal Investigator:||Andrew Chi, MD||NYU Langone Health|
|Principal Investigator:||Sylvia Kurz, MD||NYU Langone Health|
|Principal Investigator:||Erik Sulman, MD||NYU Langone Health|