Clinical trialNCT04145115Active, not recruitingPhase 2Interventional

A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden

SponsorNational Cancer Institute (NCI)Enrollment37Astrocytoma, IDH-Mutant, Grade 4Diffuse GliomaGlioblastoma, IDH-WildtypeSecondary Glioblastoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase II trial studies the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioma that has come back (recurrent) and carries a high number of mutations (mutational burden). Cancer is caused by changes (mutations) to genes that control the way cells function. Tumors with high number of mutations may respond well to immunotherapy. Immunotherapy with monoclonal antibodies 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. Giving ipilimumab and nivolumab may lower the chance of recurrent glioblastoma with high number of mutations from growing or spreading compared to usual care (surgery or chemotherapy).

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.

Gavin P Dunn
Alliance for Clinical Trials in 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

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

Puerto Rico

Pan American Center for Oncology Trials Llc
San Juan, Puerto Rico

United States

Alaska Breast Care and Surgery Llc
Anchorage, Alaska, United States
Alaska Oncology and Hematology Llc
Anchorage, Alaska, United States
Alaska Women'S Cancer Care
Anchorage, Alaska, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Cancer Center at Saint Joseph'S
Phoenix, Arizona, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Chi Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
Providence Saint Joseph Medical Center/disney Family Cancer Center
Burbank, California, United States
Mercy Cancer Center - Carmichael
Carmichael, California, United States
Mercy San Juan Medical Center
Carmichael, California, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States
Uc San Diego Moores Cancer Center
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Mercy Cancer Center - Rocklin
Rocklin, California, United States
Mercy Cancer Center - Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States
Woodland Memorial Hospital
Woodland, California, United States
Uchealth University of Colorado Hospital
Aurora, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
Adventhealth Porter
Denver, Colorado, United States
Commonspirit Cancer Center Mercy
Durango, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Commonspirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, United States
Adventhealth Littleton
Littleton, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States

374 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 →

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: 24 Dec 2020
Primary completion: 31 Dec 2026
Completion: 31 Dec 2026
Last update posted: 4 Aug 2026
Registered enrollment: 37
Registry id: NCT04145115

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.