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

NCT05022901 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-21

No results posted yet for this study

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.

Conditions

  • Metastatic Ocular Melanoma
  • Metastatic Uveal Melanoma

Interventions

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

Sponsors & Collaborators

  • Delcath Systems Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2024-03-01
Completion
2024-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022901 on ClinicalTrials.gov