Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT03367715
Phase
PHASE2
Status
Completed

Conditions

  • GBM
  • MGMT-unmethylated Glioblastoma (GBM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    study treatment on Day 1 with one dose of nivolumab 3 mg/kg
  • Ipilimumab — DRUG
    study treatment on Day 1 with one dose of ipilimumab 1mg/kg
  • Radiation Therapy (RT) — RADIATION
    total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.

Study Details

This is a single arm, open-label, phase II trial of nivolumab, ipilimumab and short-course radiation therapy in adult patients with newly diagnosed, MGMT unmethylated GBM with the primary objective of determining the overall survival at 1 year.

Key Dates

Start date
Feb 7, 2018
Status verified
Jun 2022
Primary completion
May 20, 2021
Completion
Mar 17, 2022

Study Design

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

Arms

  • Experimental: Nivolumab + Ipilimumab + Short-course radiation therapy
    within 6 weeks of the first diagnostic surgery for glioblastoma, all subjects will initiate study treatment on Day 1

Primary Outcome Measure

1-year Overall Survival (OS) [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
New York University School of MedicineNew YorkNew York10016-

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New York University School of Medicine· New York, NY

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