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Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis

NCT03903640 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-06-07

Study results available
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Summary

This phase II study will evaluate the safety of combining intermediate frequency electric field (TT Field) with immunotherapy in melanoma patients with brain metastasis. The data of this study will also inform whether this combination will offer advantage in progression free survival (PFS) and overall survival.

Conditions

  • Melanoma With Brain Metastasis

Interventions

DEVICE

Optune

-Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS.

BIOLOGICAL

Nivolumab

-Standard of care

BIOLOGICAL

Ipilimumab

-Standard of care

Sponsors & Collaborators

  • NovoCure Ltd.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • George Ansstas, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2020-06-08
Completion
2021-11-03
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03903640 on ClinicalTrials.gov