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Monoclonal Antibodies

Hypofractionated Stereotactic Irradiation for Malignant Glioma

Phase 1
Waitlist Available
Led By Solmaz Sahebjam, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of World Health Organization (WHO) Grade III or IV malignant glioma.
Documented recurrence by diagnostic biopsy or contrast enhanced magnetic resonance imaging (MRI) performed within 28 days of entry in to the trial as per Response Assessment in Neuro-Oncology (RANO) criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial is testing whether a combination of different immunotherapy drugs, given with a type of radiation treatment, is safe and tolerated by people with a certain type of brain tumor.

Eligible Conditions
  • Malignant Glioma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Treatment Related Adverse Events
Secondary outcome measures
Overall Survival (OS) Rate at 6 Months
Overall Survival (OS) Rate at 9 Months
Response Rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination TherapyExperimental Treatment4 Interventions
Safety Cohort: The first 6 participants will receive Hypofractionated Stereotactic Irradiation (HFSRT) followed by Ipilimumab + Nivolumab + Bevacizumab. Dose Expansion Cohort: All 26 participants will be treated with Hypofractionated Stereotactic Irradiation (HFSRT), followed by Ipilimumab + Nivolumab +Bevacizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Hypofractionated Stereotactic Irradiation
2016
Completed Phase 1
~40
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
538 Previous Clinical Trials
134,976 Total Patients Enrolled
Solmaz Sahebjam, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
4 Previous Clinical Trials
85 Total Patients Enrolled

Frequently Asked Questions

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

Is Nivolumab known to cause any serious health complications?

"Nivolumab's safety is largely unproven as it is only in Phase 1 trials."

Answered by AI

Nivolumab is frequently used to treat which type of cancer?

"Nivolumab is frequently used as a treatment for patients with unresectable melanoma. It is also used to manage squamous cell carcinoma, locally advanced nonsquamous non-small cell lung cancer, and high risk of recurrence."

Answered by AI

What other precedent does Nivolumab have in medical research?

"1164 studies are currently being conducted for Nivolumab with 181 of those in the final stage of testing. The majority of these studies are taking place in Pittsburgh, though there are 61232 total locations running Nivolumab trials."

Answered by AI
~4 spots leftby Mar 2025