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Trial of Combination Tumor Treating Fields (TTF; Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma

NCT03430791 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-02-02

Study results available
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Summary

Phase I/II trial in which participants with recurrent glioblastoma will receive a combination of tumor treating fields(portable device), nivolumab with or without ipilimumab.

Conditions

Interventions

DRUG

Nivolumab 240 mg IV

Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.

DRUG

Nivolumab 3 mg/kg

Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.

DRUG

Ipilimumab 1 mg/kg

Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.

DEVICE

NovoTTF200A (Optune)

A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • NovoCure Ltd.

    collaborator INDUSTRY

  • Baptist Health South Florida

    lead OTHER

Principal Investigators

  • Yazmin Odia · Miami Cancer Institute at Baptist Health, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2020-05-29
Completion
2021-01-27
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03430791 on ClinicalTrials.gov