Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Patients With Recurrent Grade II-III Meningioma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03604978
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Grade 2 Meningioma
  • Grade 3 Meningioma
  • Recurrent Meningioma

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo brain MRI
  • Nivolumab — BIOLOGICAL
    Given IV
  • Stereotactic Radiosurgery — RADIATION
    Undergo multi-fraction stereotactic radiosurgery

Study Details

This phase I/II trial studies the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating patients with grade II-III meningioma that has come back (recurrent). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Giving nivolumab and multi-fraction stereotactic radiosurgery with or without ipilimumab may work better in treating patients with grade II-III meningioma.

Key Dates

Start date
Jun 17, 2019
Status verified
Jan 2026
Primary completion
Mar 19, 2027
Completion
Mar 19, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (nivolumab, radiosurgery)
    Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo multi-fraction stereotactic radiosurgery on days 1, 3, and 5. Patients undergo brain MRI and blood sample collection throughout the study. Patients may also undergo ECHO as clinically indicated.
  • Experimental: Cohort B (nivolumab, ipilimumab, radiosurgery)
    Patients receive nivolumab IV over 30 minutes every 2 weeks for 12 doses (6 months) and then every 4 weeks for additional 6 months. Patients also receive ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 6 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients undergo multi-fraction stereotactic radiosurgery on days 1, 3, and 5. Patients undergo brain MRI and blood sample collection throughout the study. Patients may also undergo ECHO as clinically indicated.

Primary Outcome Measure

Maximum tolerated combination of radiosurgery and nivolumab plus or minus ipilimumab (Phase I) [ Time Frame: Up to 100 days ]

Locations (29)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital in ArizonaPhoenixArizona85054-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
UCHealth University of Colorado HospitalAuroraColorado80045-
UM Sylvester Comprehensive Cancer Center at AventuraAventuraFlorida33180-
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146-
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
UM Sylvester Comprehensive Cancer Center at KendallMiamiFlorida33176-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
UM Sylvester Comprehensive Cancer Center at PlantationPlantationFlorida33324-
University of Kansas Cancer CenterKansas CityKansas66160-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Mayo Clinic in RochesterRochesterMinnesota55905-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
Washington University School of MedicineSt LouisMissouri63110-
University of Nebraska Medical CenterOmahaNebraska68198-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27710-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

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By research site
Mayo Clinic Hospital in Arizona· Phoenix, AZCity of Hope Comprehensive Cancer Center· Duarte, CAUC San Diego Moores Cancer Center· La Jolla, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CA

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