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

NCT03367715 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-07-01

Study results available
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Summary

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.

Conditions

  • MGMT-unmethylated Glioblastoma (GBM)
  • GBM

Interventions

DRUG

Nivolumab

study treatment on Day 1 with one dose of nivolumab 3 mg/kg

DRUG

Ipilimumab

study treatment on Day 1 with one dose of ipilimumab 1mg/kg

RADIATION

Radiation Therapy (RT)

total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.

Sponsors & Collaborators

Principal Investigators

  • Andrew Chi, MD · NYU Langone Health

  • Sylvia Kurz, MD · NYU Langone Health

  • Erik Sulman, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-07
Primary Completion
2021-05-20
Completion
2022-03-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03367715 on ClinicalTrials.gov