RecruitingPhase 3NCT06519266

PHP in Combination With IPI1/NIVO3 Compared to IPI3/NIVO1 Only in Patients With Uveal Melanoma Liver Metastases

A Phase III Randomized Controlled Multicentre Trial of Percutaneous Hepatic Perfusion in Combination With Ipilimumab and Nivolumab Compared to Ipilimumab and Nivolumab Only in Patients With Uveal Melanoma Liver Metastases

Sponsor

Vastra Gotaland Region

Enrollment

40 participants

Start Date

Jun 10, 2024

Study Type

INTERVENTIONAL

Conditions

Liver Metastases Uveal Melanoma

Summary

Uveal melanoma is the most common primary intraocular malignancy in adults. Despite successful control of the primary tumor, metastatic disease will develop in approximately 35%-50% of the patients within 10 years. The liver is the most common site for metastases, and about 50% of the patients will have isolated liver metastases. These metastases are generally refractory to systemic chemotherapy and the median survival for patients with liver metastases is about 6 months. Regardless of treatment, the mortality rate is approximately 90% at 2 years with only about 1% of the patients surviving more than 5 years. The primary objective with this study is to evaluate progression-free survival in patients with uveal melanoma liver metastases randomized to either percutaneous hepatic perfusion (PHP) in combination with ipilimumab and nivolumab or ipilimumab and nivolumab only. Secondary objectives include further efficacy and safety analysis, as well as biomarker discovery.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of liver-directed treatment (a procedure that delivers chemotherapy directly to the liver) plus low-dose immunotherapy drugs, compared to immunotherapy alone, in people with a rare eye cancer (uveal melanoma) that has spread to the liver. **You may be eligible if...** - You are 18 or older - You have been diagnosed with uveal melanoma that has spread to the liver (confirmed by biopsy or lab tests) - The cancer is measurable on a CT scan - You have not previously been treated for this spread, OR you received tebentafusp and it stopped working - You are in good general health (able to carry out normal activities) - You are willing to use effective contraception during and for 5 months after treatment **You may NOT be eligible if...** - The cancer has spread outside the liver (such as to the lungs) - More than half of your liver is replaced by tumor - You have serious heart or lung disease that prevents general anesthesia - You have HIV, active hepatitis B or C - You have a serious autoimmune disease requiring ongoing treatment - You are pregnant or breastfeeding - Your kidneys or liver are not functioning well enough Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPHP

Patients will be treated with 2 cycles of PHP (CHEMOSAT® Hepatic Delivery System for Melphalan) six weeks apart

DRUGIPI1/NIVO3

Patients will be treated with 2 cycles of i.v. ipilimumab 1mg/kg and nivolumab 3mg/kg q3w, followed by continued i.v. nivolumab 480mg q4w up to 1 year.

DRUGIPI3/NIVO1

Patients will be treated with 4 cycles of intravenous (i.v.) infusion with ipilimumab 3mg/kg and nivolumab 1mg/kg q3w followed by continued i.v. nivolumab 480mg q4w up to 1 year.