Clinical trialNCT04396860CompletedPhase 2/PHASE3Interventional

Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma

SponsorNational Cancer Institute (NCI)Enrollment159GliosarcomaMGMT-Unmethylated Glioblastoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase II/III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy in combination with immunotherapy with ipilimumab and nivolumab in treating patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses high energy photons to kill tumor and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temozolomide, may not work as well for the treatment of tumors that have the unmethylated MGMT. Immunotherapy with monoclonal antibodies called immune checkpoint inhibitors, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is possible that immune checkpoint inhibitors may work better at time of first diagnosis as opposed to when tumor comes back. Giving radiation therapy with ipilimumab and nivolumab may lengthen the time without brain tumor returning or growing and may extend patients' life compared to usual treatment with radiation therapy and temozolomide.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Andrew B Lassman
NRG Oncology
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

285 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim
Anaheim, California, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
John Muir Medical Center-Concord
Concord, California, United States
Uc San Diego Moores Cancer Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Kaiser Permanente-Ontario
Ontario, California, United States
Uc Irvine Health/chao Family Comprehensive Cancer Center
Orange, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Adventhealth Porter
Denver, Colorado, United States
Adventhealth Littleton
Littleton, Colorado, United States
Adventhealth Parker
Parker, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
the Hospital of Central Connecticut
New Britain, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians Pa
Newark, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants Pa
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Baptist Md Anderson Cancer Center
Jacksonville, Florida, United States
Adventhealth Orlando
Orlando, Florida, United States
Augusta University Medical Center
Augusta, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph'S/candler
Savannah, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, United States

245 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Ipilimumab →Nivolumab →Temozolomide →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Sept 2020
Primary completion: 13 Jan 2023
Completion: 23 Dec 2025
Last update posted: 22 Apr 2026
Registered enrollment: 159
Registry id: NCT04396860

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.