Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Nervous System Diseases

Rare Diseases

Neoplasm Metastasis

Melanoma

Brain Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

* 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

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

Optune

George Ansstas, M.D.

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.

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

Phase II Study of Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis

* The PFS time will be calculated as the duration of time from the date of first dose of study treatment to the date of earliest intracranial progression or death, whichever occurs first.
* Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

-Defined as the duration of time from the date of first dose of study treatment to death from any cause.

* Defined as the percentage of patients with a confirmed intracranial complete or partial response
* Using modified RANO criteria

* Defined as the percentage of patients with a confirmed extracranial complete or partial response
* Using modified RANO criteria

* Defined as the duration of time from the date of first dose of study treatment to the date of earliest extracranial progression or death, whichever occurs first. Patients who neither progress nor die by the data cutoff date will be censored at the last follow up.
* Using modified RANO criteria

-The descriptions and grading scales found in CTCAE version 5.0.

NovoCure Ltd.

Washington University School of Medicine

Optune + Ipilimumab + Nivolumab

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The study was opened to enrollment from 07/01/2019 through 03/09/2022. The study was terminated early due to low enrollment. The low enrollment was due to the COVID-19 pandemic and no external referrals for the trial. The Principal Investigator reached out to other academic institutions about opening the trial but there was not any interest.

Dr. George Ansstas

Intracranial Progression-free Survival

Overall Survival

Best Intracranial Response Rate

Best Extracranial Response Rate

Extracranial Progression-free Survival

Safety of the Treatment Regimen as Measured by Number of Participants With Treatment-related Grade 3 or Greater Adverse Events

Safety of the Treatment Regimen as Measured by Number of Participants With Discontinuations Due to Treatment Related Adverse Events.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis	NCT03903640	Melanoma With B...	Optune Nivolumab Ipilimumab	18 Years -	Washington University School of Medicine
Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis	NCT03903640	Melanoma With B...	Optune Nivolumab Ipilimumab	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for melanoma with brain metastasis