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

Part of paid clinical trials in San Francisco, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02311920
Phase
PHASE1
Status
Completed

Conditions

  • Gliosarcoma
  • Supratentorial Glioblastoma

Eligibility Criteria

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

Interventions

  • Ipilimumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV
  • Temozolomide — DRUG
    Given PO

Study Details

This phase I trial studies the safety and best dose of ipilimumab, nivolumab, or both in combination with temozolomide in treating patients with newly diagnosed glioblastoma or gliosarcoma. Monoclonal antibodies, such as ipilimumab and nivolumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known which combination is a better treatment for glioblastoma or gliosarcoma.

Key Dates

Start date
Apr 16, 2015
Status verified
Jan 2023
Primary completion
Dec 31, 2017
Completion
Dec 22, 2022

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (temozolomide and ipilimumab)
    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.
  • Experimental: Arm II (temozolomide and nivolumab)
    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.
  • Experimental: Arm III (temozolomide, nivolumab, ipilimumab)
    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.

Primary Outcome Measure

Immune-related dose-limiting toxicities for the single-agent treatment with ipilimumab [ Time Frame: Up to 8 weeks ]

Locations (11)

FacilityCityStateZIPSite coordinators
UCSF Medical Center-ParnassusSan FranciscoCalifornia94143-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
University of Maryland/Greenebaum Cancer CenterBaltimoreMaryland21201-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Case Western Reserve UniversityClevelandOhio44106-
Cleveland Clinic Cancer Center/Fairview HospitalClevelandOhio44111-
Cleveland Clinic FoundationClevelandOhio44195-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in San Francisco, CA

By research site
UCSF Medical Center-Parnassus· San Francisco, CAEmory University Hospital/Winship Cancer Institute· Atlanta, GAUniversity of Maryland/Greenebaum Cancer Center· Baltimore, MDNational Institutes of Health Clinical Center· Bethesda, MDDana-Farber Cancer Institute· Boston, MANYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center· New York, NY

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