Our Goal

Upon approval, to be the treatment of choice for patients with ocular melanoma liver metastases

Disease Focus

Ocular melanoma, also referred to as uveal melanoma, is a cancer that originates in the eye.  Approximately 4,500 patients in the United States and Europe are diagnosed with ocular melanoma each year. About half of patients diagnosed with ocular melanoma develop metastatic disease (cancer spreads beyond the primary source). Of those, the liver is the first site of metastases 80-90% of the time.

Delcath aims to change the lives of patients suffering with ocular melanoma liver metastases through our clinical program.

FOCUS Global Registration Clinical Trial – Enrolling Now

click here for further information 

Study Title

A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma

Study objective

This study will evaluate the effect of treatments on Objective Response Rate, the duration of response, disease control rate, how long patients live, how long it takes for the cancer to respond to the treatment or to advance, and quality of life, among other measures.

Who is Eligible?

You may be able to enroll in the FOCUS trial if you:

  • Are an adult who weighs at least 80 pounds
  • Have tumors in no more than one-half of the liver
  • Have cancer that has spread to the skin, lung, or bone, as long as it’s limited
  • Have had previous therapies that didn’t work
  • Are in good overall health (determined by examination and blood work) with an otherwise healthy liver

Exclusion Criteria

Patients may be excluded from enrolling in the trial if they:

  • Have cirrhosis of the liver
  • Have active significant heart or lung problems
  • Have had current or past significant bleeding problems
  • Have cancer that has spread to the brain
  • Have diabetes that is not controlled
  • Are Pregnant

Interested patients should consult with a healthcare professional to see if you meet the entry criteria. For further information on inclusion and exclusion criteria please click here.

What Will Happen During the Trial?

If you qualify for and decide to participate in the FOCUS trial, additional requirements are:

  • You will receive treatment about every 6 weeks for up to 6 treatments and stay in the hospital for 3 days
  • All patients will get blood work done between treatments at the hospital.
  • All patients will be evaluated by CAT scans or MRIs to determine cancer status every 10-14 weeks.
  • All patients will receive Melphalan/HDS until the cancer worsens or the maximum number of treatments has been reached

Where is the treatment available?

The FOCUS Trial is currently being conducted at 22 leading cancer institutes worldwide. Click on the interactive map below to view locations in the United States and Europe or to find out more email medaffairgroup@delcath.com

FOCUS Trial Locations