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

Scottsdale/Phoenix, AZ, Rochester, MN, Eau Claire, WI, Jacksonville, FL, La Crosse, WI

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

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to evaluate the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioblastoma that has come back (recurrent) and carries a high number of mutations. 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).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Contact us for the latest status	View complete study & contact information
Rochester, Minn.	Contact us for the latest status
La Crosse, Wis.	Closed for enrollment
Scottsdale/Phoenix, Ariz.	Contact us for the latest status
Eau Claire, Wis.	Contact us for the latest status

Print study details

Site IRB:
- Jacksonville, Florida: 20-011985
- Rochester, Minnesota: 20-011985
- La Crosse, Wisconsin: 20-011985
- Scottsdale/Phoenix, Arizona: 20-011985
- Eau Claire, Wisconsin: 20-011985
NCT ID:
NCT04145115
Sponsor Protocol Number:
A071702

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information
Scottsdale/Phoenix, Ariz.	Open for enrollment

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Contact us for the latest status	View complete study & contact information

Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study

Scottsdale/Phoenix, AZ, Rochester, MN, Jacksonville, FL, Mankato, MN, Albert Lea, MN, Eau Claire, WI, La Crosse, WI

See Details

Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to demonstrate non-inferior 12-month overall survival of patients with GlioblastomA (GBM) treated with dose escalated hypofractionated radiotherapy compared to standard of care. Also, to demonstrate the safety and favorable quality of life via physician-reported G3+ toxicitycompare if SBRT is non-inferior to standard of care on the proportion of overall survival of patients with glioblastoma 12 months after randomization.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Mankato, Minn.	Open for enrollment
La Crosse, Wis.	Open for enrollment
Jacksonville, Fla.	Open for enrollment
Eau Claire, Wis.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment
Albert Lea, Minn.	Open for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 22-006990
- Mankato, Minnesota: 22-006990
- La Crosse, Wisconsin: 22-006990
- Jacksonville, Florida: 22-006990
- Eau Claire, Wisconsin: 22-006990
- Scottsdale/Phoenix, Arizona: 22-006990
- Albert Lea, Minnesota: 22-006990
NCT ID:
NCT05781321
Sponsor Protocol Number:
GMROR2261

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Open for enrollment	View complete study & contact information
Rochester, Minn.	Closed for enrollment

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Search Results 11-20 of 20 for

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

Gemini Study to Evaluate the Integration of Cancer Genetic Testing into a Cancer Clinical Practice at Mayo Clinic at Arizona

Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors

Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study

A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM

A Study to Evaluate Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer

A Study of the Possible Use of a New Imaging Method with Glioma Tumors

Patient Adherence and Symptoms During Post-operative Fluid Restriction Protocol After Transsphenoidal Surgery

Image-based Mapping of Brain Tumors

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