Metastatic Uveal Melanoma: Tumor-Treating Fields With Nivolumab and Ipilimumab

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and efficacy of the novel device/drug combination of the Novocure NovoTTF-200(O) with nivolumab and ipilimumab in patients with metastatic uveal melanoma. The tumor-treating fields (TTF) are formed using array patches placed on the skin and deliver electric fields that are hypothesized to disrupt cellular structures in uveal melanoma metastatic tumors. Since large numbers of uveal melanomas recur in the liver, array patches are placed on the abdomen and remain there for at least 18 hours per day. Similar devices have shown benefit in brain tumors such as glioblastoma multiforme.


Eligibility

  • Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement
  • Age 18 years or older and willing and able to provide informed consent
  • WOCBP must have a negative serum pregnancy test documented with 72 hours of first administration of drug
  • Sexually active and WOCBP, patient and partner must agree to use adequate contraception
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Where can I participate?

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute : Saba Mukarram

More about this Clinical Trial

What is the full name of this clinical trial?

TTFIELDS-UM: First in Human Early Feasibility Study of Tumor-Treating Fields in Combination with Nivolumab and Ipilimumab in Metastatic Uveal Melanoma

Study Details
Disease Type/Condition

Melanoma

Principal Investigator

Mehmi, Inderjit

Co-Investigators

Ani Balmanoukian, Cathie T Chung, Iryna Singh, Justin Moyers, Kristopher Wentzel, Navid Hafez, Omid Hamid, Vi K. Chiu

Age Group

Adult

Phase

I

IRB Number

STUDY00002206

ClinicalTrials.gov ID

NCT05004025

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Saba Mukarram

Phone
+1 310-231-2181
Email
MukarramS@cshs.org
Study Detail
Disease Type/Condition

Melanoma

Principal Investigator

Mehmi, Inderjit

Age Group

Adult

Phase

I

IRB Number

TTFIELDS-UM

ClinicalTrials.gov ID

NCT05004025

Key Eligibility
ClinicalTrials.gov

Contact
Name

Saba Mukarram

Phone
+1 310-231-2181
Email
MukarramS@cshs.org