PHP and Immunotherapy in Metastasized UM

Sponsor
Leiden University Medical Center
Study ID
NCT04283890
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Uveal Melanoma, Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab and nivolumab — DRUG
    The effect of ipilimumab and nivolumab has previously been tested in metastatic uveal melanoma. In this study the combination with percutaneous hepatic perfusion will be performed in order to evaluate the effect.
  • Melphalan chemosaturation via percutaneous hepatic perfusion — DRUG
    The effect of ipilimumab and nivolumab has previously been tested in metastatic uveal melanoma. In this study the combination with percutaneous hepatic perfusion will be performed in order to evaluate the effect.

Study Details

Melanoma of the eye (ocular/uveal melanoma) is an uncommon type of cancer that is associated with a high mortality. It usually disseminates rapidly throughout the body, most commonly to the liver and lungs. In this study a combination therapy with immunotherapy (ipilimumab with nivolumab) and chemotherapy (melphalan) will be assessed for the treatment of disseminated uveal melanoma. Melphalan will be administered selectively to the liver via percutaneous hepatic perfusion, limiting the systemic effect of chemotherapy. With this treatment combination we aim to find a treatment for disseminated uveal melanoma, both in the liver as in the other organs.

Key Dates

Start date
Dec 4, 2019
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2029

Study Design

Enrollment
83 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib
  • Active Comparator: Phase II - Combination treatment
  • Active Comparator: Phase II - PHP

Primary Outcome Measure

Toxicity and safety of treatment [ Time Frame: 36 weeks ]

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