Surgical Nivolumab And Ipilimumab For Recurrent GBM

Part of paid clinical trials in Los Angeles, California.

Sponsor
Patrick Wen, MD
Study ID
NCT04606316
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab-Placebo — DRUG
    Intravenous (IV) solution that has no therapeutic effect, used as a control in testing investigational drug. One dose is received prior to surgery.
  • Nivolumab — DRUG
    Given as intravenous (IV) infusion into a vein.
  • Ipilimumab-Placebo — DRUG
    Intravenous (IV) solution that has no therapeutic effect, used as a control in testing investigational drug. One dose is received prior to surgery.
  • Ipilimumab — DRUG
    Given as intravenous (IV) infusion into a vein.
  • Surgery — PROCEDURE
    Treatment of disease or injury by cutting, abrading, suturing, or otherwise physically changing body tissues and organs.

Study Details

This research trial is studying the safety and effectiveness of nivolumab in combination with ipilimumab and surgery when used in the treatment of recurrent glioblastoma. The names of the study drugs involved in this study are: * Nivolumab * Ipilimumab * Placebo (IV solution with no medicine) * Zr-89 Crefmirlimab berdoxam (optional sub-study)

Key Dates

Start date
Feb 1, 2021
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Nivolumab and Ipilimumab Before and After Surgery
    One dose of nivolumab plus ipilimumab will be administered 14(±5) days before surgery. After surgery, participants receive nivolumab in combination with ipilimumab every 3 weeks for 9 weeks and then nivolumab alone every 4 weeks.
  • Experimental: Nivolumab and Placebo-Ipilimumab Before Surgery, Nivolumab After Surgery
    One dose of nivolumab plus placebo-ipilimumab will be administered 14(±5) days before surgery. After surgery, participants receive nivolumab in combination with ipilimumab every 3 weeks for 9 weeks and then nivolumab alone every 4 weeks.
  • Experimental: Placebo-Nivolumab and Placebo-Ipilimumab Before Surgery, Nivolumab and Ipilimumab After Surgery
    One dose of placebo-nivolumab plus placebo-ipilimumab will be administered 14(±5) days before surgery. After surgery, participants receive nivolumab in combination with ipilimumab every 3 weeks for 9 weeks and then nivolumab alone every 4 weeks

Primary Outcome Measure

Tumor Infiltrating T Lymphocyte (TIL) Density [ Time Frame: 24 Months ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095-
Stanford UniversityStanfordCalifornia94305-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in Los Angeles, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of California Los Angeles· Los Angeles, CAStanford University· Stanford, CADana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NY

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