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Checkpoint Inhibitor

Ipilimumab for Gliosarcoma

Q: How many sites are involved in the administration of this research trial?

<p>The M D Anderson <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in Houston, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>; <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a> State University Comprehensive Cancer Centre in Columbus, Ohio; and the Cleveland Clinic Foundation in Cleveland, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> are three of 15 sites hosting this trial. The remaining 11 locations can be found on our website.</p>

Phase 1

Waitlist Available

Led By Mark R Gilbert

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years after the start of immunotherapy treatment

Awards & highlights

Study Summary

This trial is studying the safety and best dose of ipilimumab, nivolumab, or both in combination with temozolomide for treating patients with newly diagnosed glioblastoma or gliosarcoma.

Eligible Conditions

Glioblastoma
Gliosarcoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years after the start of immunotherapy treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years after the start of immunotherapy treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after the start of immunotherapy treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Immune-related dose-limiting toxicities for the combination of ipilimumab and nivolumab when given with temozolomide

Immune-related dose-limiting toxicities for the single-agent treatment with ipilimumab

Immune-related dose-limiting toxicities for the single-agent treatment with nivolumab

Secondary outcome measures

Biomarker analysis of immune cells within tumor samples using standard immunohistochemistry

Incidence of adverse events, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Number of patients who are alive

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm III (temozolomide, nivolumab, ipilimumab)Experimental Treatment4 Interventions

Within 5 weeks after completion of chemoradiation, patients receive temozolomide PO on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 90 minutes once every 4 weeks for 4 courses and nivolumab IV over 60 minutes once every 2 weeks for 64 weeks in the absence unacceptable toxicity.

Group II: Arm II (temozolomide and nivolumab)Experimental Treatment3 Interventions

Within 5 weeks after completion of chemoradiation, patients receive temozolomide PO on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 60 minutes once every 2 weeks for 16 weeks and then once every 2 weeks for 48 weeks in the absence unacceptable toxicity.

Group III: Arm I (temozolomide and ipilimumab)Experimental Treatment3 Interventions

Within 5 weeks after completion of chemoradiation, patients receive temozolomide PO on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 90 minutes once every 4 weeks for 4 courses and then beginning 3 months after course 4 once every 3 months for 4 courses in the absence unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~2670

Nivolumab

2014

Completed Phase 3

~4750

Temozolomide

2010

Completed Phase 3

~1930

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,121 Total Patients Enrolled

142 Trials studying Gliosarcoma

10,793 Patients Enrolled for Gliosarcoma

NRG OncologyOTHER

231 Previous Clinical Trials

100,820 Total Patients Enrolled

9 Trials studying Gliosarcoma

3,507 Patients Enrolled for Gliosarcoma

Mark R GilbertPrincipal InvestigatorNRG Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities currently available for this investigation?

"Currently, this trial is not open to enrollment. Latest updates to the clinical trial information were made on September 20th 2022 and it was initially posted in April 2015. For those seeking other trials, there are 443 gliosarcoma studies with active recruitment and 960 Ipilimumab studies that are currently enrolling participants."

Answered by AI

What other investigations has Ipilimumab been part of?

"Ipilimumab was first examined in 2002 by Memorial Sloan Kettering Cancer Center and since then, 1192 clinical trials have been finished. At this current moment, there are 960 active studies with Houston being a major hub for them."

Answered by AI

How many sites are involved in the administration of this research trial?

"The M D Anderson Cancer Center in Houston, Texas; Ohio State University Comprehensive Cancer Centre in Columbus, Ohio; and the Cleveland Clinic Foundation in Cleveland, New york are three of 15 sites hosting this trial. The remaining 11 locations can be found on our website."

Answered by AI

Is this endeavor the inaugural one of its genre?

"Since 2002, Ipilimumab has been studied. Initial trials were conducted by Schering-Plough and involved 60 patients. Following the success of this initial trial, Phase 2 drug approval was granted for ipilimumab in 2002. Nowadays there are 960 experiments taking place across 2486 cities and 51 countries to further study its efficacy."

Answered by AI

In what circumstances is it typical to administer Ipilimumab?

"Ipilimumab has shown to be effective in treating cases of malignant neoplasms, unresectable melanoma and squamous cell carcinomatous proliferation."

Answered by AI

Has Ipilimumab been certified by the FDA?

"The safety profile of Ipilimumab is rated at 1 due to the limited clinical data available, as this drug is currently undergoing its initial phase of testing."

Answered by AI

How many participants are currently signed up for this experiment?

"The clinical trial, posted April 16th 2015 and last updated September 20th 2022, is presently not enrolling patients. If you are seeking other medical studies relating to gliosarcoma or ipilimumab there are 443 and 960 respective trials actively admitting participants."

Answered by AI

Recent research and studies

BMC CancerJournal

Clinical Decision Making in the Era of Immunotherapy for High Grade-glioma: Report of Four Cases

Ranjan, Surabhi, Martha Quezado, Nancy Garren, Lisa Boris, Christine Siegel, Osorio Lopes Abath Neto, Brett J. Theeler, et al.. 2018. “Clinical Decision Making in the Era of Immunotherapy for High Grade-glioma: Report of Four Cases”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-018-4131-1.

clinicaltrials.govStudy

Ipilimumab and/or Nivolumab in Combination With Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

2015. "Ipilimumab and/or Nivolumab in Combination With Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02311920.