Hypofractionated Stereotactic Irradiation With Nivolumab, Ipilimumab and Bevacizumab in Patients With Recurrent High Grade Gliomas

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT02829931
Phase
PHASE1
Status
Completed

Conditions

  • Malignant Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hypofractionated Stereotactic Irradiation — RADIATION
    Hypofractionated Stereotactic Irradiation (HFSRT) prior to nivolumab.
  • Nivolumab — DRUG
    Nivolumab intravenously (IV): 240 mg every (q) 3 weeks x 4 months followed by 480 mg X 4 months.
  • Bevacizumab — DRUG
    Bevacizumab intervenously (IV): 15 mg/kg every (q) 3 weeks when given with Ipilumumab and Nivolumab combination. Dose changed to 10mg/kg every 2 weeks when given with Nivolumab only.
  • Ipilimumab — DRUG
    Ipilimumab 1mg/kg intervenously (IV) 200 mg (5 mg/mL) every (q) 3 weeks for 4 months.

Study Details

The main purpose of this study is to evaluate the safety, and tolerability of nivolumab, ipilimumab, and bevacizumab given in combination with hypofractionated stereotactic re-irradiation of recurrent high grade gliomas.

Key Dates

Start date
Aug 22, 2016
Status verified
Jan 2023
Primary completion
Aug 11, 2021
Completion
Nov 22, 2022

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Therapy
    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

Primary Outcome Measure

Number of Participants with Treatment Related Adverse Events [ Time Frame: Up to 24 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Tampa, FL

By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FLOhio State University Comprehensive Cancer Center· Columbus, OH

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