Phase1b/2 Study Combining Hepatic Percutaneous Perfusion With Ipilimumab Plus Nivolumab in Advanced Uveal Melanoma (CHOPIN)

NCT04283890 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Leiden University Medical Center
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	83
Start date	2019-12-04
Completion	2029-12

Conditions

• Uveal Melanoma, Metastatic

Interventions

• Ipilimumab and nivolumab
• Melphalan chemosaturation via percutaneous hepatic perfusion

Primary outcomes

• Toxicity and safety of treatment — 36 weeks
  Dose limiting toxicities, maximum tolerated dose and recommended phase dose of the combination ipilimumab/nivolumab and PHP in patients with unresectable, histologically confirmed hepatic metastasis of uveal melanoma in phase Ib part.
• Efficacy and safety — 1 year
  Description of PFS according to RECIST 1.1 at one year in the PHP group versus PHP + ipilimumab/nivolumab group in the phase II part.

Countries

Netherlands