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

Conditions

• Melanoma With Brain Metastasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Optune — DEVICE
  -Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS.
• Nivolumab — BIOLOGICAL
  -Standard of care
• Ipilimumab — BIOLOGICAL
  -Standard of care

Study Details

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.

Key Dates

Start date

Oct 14, 2019

Status verified

May 2022

Primary completion

Jun 8, 2020

Completion

Nov 3, 2021

Study Design

Enrollment

2 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Optune + Ipilimumab + Nivolumab
  * Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. * Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses * Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy. * Treatment may continue for up to 1 year

Primary Outcome Measure

Intracranial Progression-free Survival [ Time Frame: At 6 months (up to 184 days) ]

Locations (1)

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