NCT05022901

An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Delcath Systems Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients in the study will be treated with Melphalan/HDS and will receive up to 6 total treatments. This study will evaluate the safety and effects of the treatment.

Detailed description

The study will consist of 3 phases: Screening/Baseline Phase: Screening assessments will be conducted within 28 days prior to the eligibility date to determine each patient's overall eligibility and baseline characteristics. These assessments will include medical history, physical examination, Eastern Cooperative Oncology Group (ECOG) performance status (PS), Quality of Life questionnaire, 12 lead electrocardiogram (ECG), echocardiogram (ECHO), vital signs, full hematology and biochemistry, Quality of Life questionnaire, radiologic assessments of baseline disease status and concomitant medications. For patients with a history of liver surgery or major vasculature surgery, an angiogram evaluation of their vasculature will be performed for compatibility for Percutaneous Hepatic Perfusion (PHP) prior to confirming eligibility. Eligibility date: This is the date on which all screening assessments have been completed and the patient is determined to be eligible for the trial. Treatment Phase: The first study treatment should occur within 14 days of the eligibility date. Eligible patients will be treated with Melphalan/HDS 3.0 mg/kg Ideal Body Weight (IBW). Melphalan/HDS treatment will be administered every 6 weeks for a total of 6 cycles with an acceptable delay of another 2 weeks before the next planned treatment to allow for recovery of melphalan-related toxicity, if needed. Tumor response will be assessed every 12 weeks (+ 2 weeks) until disease progression. Patients with progressive disease (PD) will be discontinued from study treatment, and will continue to be followed until death. Melphalan/HDS treatment will also be discontinued if recovery from treatment related toxicity requires more than 8 weeks from the last treatment. An end-of-treatment visit (EOT) will be conducted approximately 6 to 8 weeks following the final study treatment. Follow-up Phase: Once the patient has completed the end-of-treatment (EOT) visit in accordance with the schedule of events they will enter the follow-up phase. If the disease has not progressed at the EOT, the patient will need to continue with disease assessment visits every 12 weeks (± 2 weeks) until disease progression is documented. After disease progression, follow-up is to be by phone every 3 months for survival status until death.

Conditions

• Metastatic Ocular Melanoma
• Metastatic Uveal Melanoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Melphalan (3 mg/kg IBW) with Hepatic Delivery System (HDS)	Melphalan administered directly to the liver via the Hepatic Delivery System (HDS) infused over a 30 minute period, followed by a 30 minute washout period

Timeline

• Start date: 2022-06-10
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2021-08-26
• Last updated: 2023-12-21

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study