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CompletedNCT02678572FOCUSUpdated Sep 10, 2026Results posted

Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma

A Phase 3 interventional study of Melphalan/HDS in Ocular Melanoma and Uveal Melanoma, sponsored by Delcath Systems Inc.. Completed at 22 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Delcath Systems Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
102
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate patients who have ocular melanoma that has spread from the eye to the liver: Patients in the study will be treated with Melphalan/HDS up to 6 total treatments and will be followed until death. This study will evaluate the safety and efficacy of the treatment and how long patients live and how long it takes for the cancer to advance or respond to the treatment.

Read the detailed description

The study will consist of 3 phases: a screening phase, treatment phase, and follow-up phase.

Screening 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), 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: Eligible patients will be treated with Melphalan/HDS 3.0 mg/kg Ideal Body Weight (IBW) and must begin treatment within 14 days being eligible. Melphalan/HDS treatment, patients will receive up to 6 treatments. Each treatment cycle consists of 6 weeks with an acceptable delay for 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. If the patient receives only 1 treatment, the disease assessment scans will be conducted 12 weeks after the date of the first treatment. The assessment scans will be reviewed by an Independent Review Committee (IRC), also referred to as Independent Central Review. At any time when progressive disease (PD) is observed, the patient will be removed from further study treatment and followed until death. Melphalan/HDS treatment will also be discontinued in the event that recovery from treatment related toxicity requires more than 8 weeks from last treatment. An end-of-treatment visit will be conducted approximately 6 to 8 weeks following the final study treatment. Ongoing treatment related adverse events (AEs) at the end-of-treatment visit will be followed until the severity is within one of the following parameters (1) Symptoms are resolved or return to baseline; (2) CTCAE Grade \< 1 or can be explained; (3) patient death. The maximum possible duration of the study treatment for any patient will be 12 months.

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 (Section 6.2), the patient will need to continue with disease assessment visits every 12 weeks (+ 2 weeks) until disease progression is documented. If the disease has progressed before or at the EOT their follow-up is to be by phone every 3 months for survival status until death.

Patients will be monitored, following the completion of study treatment, for the development of myelodysplasia and secondary leukemia.

02

Conditions studied

  • Ocular Melanoma
  • Uveal Melanoma

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Keywords

  • melphalan
  • PHP
  • chemosaturation
  • Delcath
  • ocular melanoma
  • uveal melanoma
  • percutaneous hepatic perfusion
  • liver metastasis
03

In context

Uveal Melanoma

103 studies on the registry are indexed under Uveal Melanoma; 38 are open to participants now.

This study's enrollment of 102 is above the median of 42 across 93 interventional studies indexed under Uveal Melanoma.

Browse Uveal Melanoma studies →

Lead sponsor

Delcath Systems Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female patients ≥ 18 years of age.
  2. Patients must weigh ≥ 35 kg (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).
  3. 50% or less histologically or cytologically-proven ocular melanoma metastases in the parenchyma of the liver.
  4. Disease in the liver must be measurable by computed tomography (CT) and/or magnetic resonance imaging (MRI).
  5. Evidence of limited extrahepatic disease on preoperative radiological studies is acceptable if the life threatening component of disease is in the liver. Limited extrahepatic disease is defined in this protocol as follows: metastasis in bone, subcutaneous, lung or lymph nodes that is amenable to resection or radiation and has a defined treatment plan. Patients with extra-hepatic tumor burden which does not have a defined treatment plan (i.e. monitor or is unable to be resected or radiated) must not be included in the trial.
  6. Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and MRI of the liver) must be performed within 28 days prior to randomization. An MRI of the liver is required at screening to validate that CT accurately reflects the extent of disease in the liver. For patients with MRI intolerance, a 3-phase liver CT is to be done in place of liver MRI.
  7. Patients must not have chemotherapy, radiotherapy, chemoembolization, radioembolization, or immunoembolization for their malignancy within 30 days prior to treatment and must have recovered from all side effects of therapeutic and diagnostic interventions except those listed in Appendix B of the study protocol.
  8. Patients receiving anti programmed cell death protein 1 (PD-1) immunotherapy such as pembrolizumab or nivolumab, or human cytotoxic T-lymphocyte antigen 4 blocking antibody such as ipilimumab should wait 8 weeks before Melphalan/HDS treatment.
  9. Patients must have an ECOG PS of 0-1 at screening and on the day prior to treatment.
  10. Patients must have adequate hepatic function as evidenced by total serum bilirubin ≤ 1.5 x the upper limit of normal (ULN) and a prothrombin time (PT) within 2 seconds of the upper normal limit. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) must be ≤ 2.5 x ULN.
  11. Patients must have a platelet count > 100,000/µL, hemoglobin ≥ 10.0 gm/dL, white blood cell count (WBC) > 2,000/uL, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, and a serum creatinine ≤ 1.5 mg/dL unless the measured creatinine clearance is > 40 mL/min/1.73 m2.
  12. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (β-human chorionic gonadotropin) within 7 days prior to randomization.
  13. Provided signed informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patients with Child-Pugh Class B or C cirrhosis or with evidence of portal hypertension by history, endoscopy, or radiologic studies.
  2. Those with New York Heart Association functional classification II, III or IV active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.
  3. History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
  4. Women of childbearing potential (WOCBP) i.e. fertile meaning not permanently sterilized and having had a menstrual period within the past 12 months) unable to undergo hormonal suppression to avoid menstruation during treatment.
  5. WOCBP and fertile males (not permanently sterile by bilateral orchidectomy) unwilling or unable to use highly effective contraception method for consent to at least 6 months after the last administration of study treatment (e.g. combined hormonal contraception; progestogen-only hormonal contraception; Intrauterine device, intrauterine hormone-releasing system; bilateral tubal occlusion, vasectomized partner or sexual abstinence).
  6. Females that are pregnant or breastfeeding patients
  7. Patients taking immunosuppressive drugs; however, oral corticosteroids ≤ 10 mg/day are allowed.
  8. Patients who are unable to be temporarily removed from chronic anti-coagulation therapy.
  9. Patients with active bacterial infections with systemic manifestations (malaise, fever, leucocytosis) are not eligible until completion of appropriate therapy.
  10. Patients with severe allergic reaction to iodine contrast, which cannot be controlled by premedication with antihistamines and steroids (because a hepatic angiogram is needed for the Delcath system procedure).
  11. Patients with a history of or known hypersensitivity to melphalan or the components of the Melphalan/HDS system.
  12. Patients with latex allergy.
  13. Patients with a history of hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
  14. Patients with a history of bleeding disorders or evidence of intracranial abnormalities which would put them at risk for bleeding with anti-coagulation (e.g., strokes, active metastases).
  15. Patients with a history of gastrinoma, hepatic vasculature incompatible with perfusion, hepatofugal flow in the portal vein or known unresolved venous shunting.
  16. Known varices at risk of bleeding, including medium or large esophageal or gastric varices, or active peptic ulcer.
  17. Patients with prior Whipple's procedure.
  18. Patients with brain metastases or presence of other intracranial lesions at risk for bleeding by history or baseline radiologic imaging.
  19. Patients with active liver infection, including Hepatitis B and Hepatitis C infection. Patients with anti-hepatitis B core antibody (HBc) positive, or hepatitis B surface antigen (HBsAg) but DNA negative are exception(s).
  20. Uncontrolled endocrine disorders including diabetes mellitus, hypothyroidism, or hyperthyroidism.
  21. Received any investigational agent for any indication within 30 days prior to first treatment.
  22. Not recovered from side effects of prior therapy to ≤ Grade 1 (according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 4.03). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at > Grade 1.
  23. Cancers other than ocular melanoma for which the patient is currently under treatment or still deemed not to be cancer free.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    Melphalan/HDS

    3 mg/kg ideal body weight of melphalan for infusion administered directly to the liver via percutaneous hepatic perfusion (PHP) over 30 minutes followed by a 30 minute washout. Treatment cycles are to be repeated every 6-8 weeks until disease progression.

    Combination Product: Melphalan/HDS

Interventions

  • Combination productMelphalan/HDS

    Melphalan (3 mg/kg IBW) with Hepatic Device System (HDS)

    Also known as: Alkeran

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR) as Determined by Independent Central Review Committee.

    Objective Response Rate (partial or complete) as determined by Independent Central Review Committee. This is assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Time frame: Patients will be assessed for ORR from baseline through completion of treatment. [assessed up to 36 months].

Secondary outcomes

  1. Duration of Response (DOR) as Determined by Independent Central Review Committee

    Duration of Response (DOR) is defined as the time from first documented confirmed response of CR or PR based on RECIST v1.1 determined by the IRC to the first documented progression or death due to any cause. This is determined by MRI and / or CT imaging that is conducted every 12 weeks on all patients that started study treatment.

    Time frame: From time of 1st treatment until there is evidence of disease progression [assessed up to 36 months]

  2. Disease Control Rate (DCR) Determined by Independent Central Review Committee

    DCR is defined as the proportion of patients with a best overall response of CR of any duration, PR of any duration, or stable disease (SD) for a minimum of 12 weeks from the eligibility date for PHP-OCM-301A patients (and randomization date for PHP-OCM-301 patients). This is determined by the evaluation of MRI and / or CT imaging conducted every 12 weeks on all patients that have received study treatment.

    Time frame: ORR will be assessed every 10-14 weeks from the start of 1st treatment and continues until the earlier of either when there is evidence of disease progression or 1 year from 1st treatment up to 12 months.

  3. Overall Survival

    Overall Survival will be measured from the eligibility date for PHP-OCM-301A patients (and randomization date for PHP-OCM-301 patients) to the date of death (included all-cause mortality).

    Time frame: From the start of the study to the date the patient was last known alive. [assessed up to 36 months]

  4. Progression-Free Survival

    PFS is defined as the time from the eligibility date for PHP-OCM-301A patients (and randomization date for PHP-OCM-301 patients) to the first occurrence of disease progression (either hepatic or extra-hepatic), as determined by the Investigator and / or Independent Central Review Committee assessments using RECIST (version 1.1), or death from any cause. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Time frame: From start of study until disease progression. [assessed up to 36 months]

Other outcomes

  1. Time to Objective Response (TOR)

    TOR will be assessed and the results for median with 95% confidence intervals using Kaplan-Meier time-to-event analysis techniques will be presented. This is determined by the evaluation of MRI and / or CT imaging conducted every 12 weeks on all patients that have received study treatment.

    Time frame: From study start through study completion. [Assessed up to 36 months]

  2. Hepatic Progression Free Survival (hPFS)

    Hepatic PFS (hPFS) is defined as the time from the eligibility date for the PHP-OCM-301A patients (and randomization date for PHP-OCM-301 patients) to the first occurrence of hepatic disease progression, as determined by the Independent Central Review Committee (IRC) on imaging studies using RECIST 1.1 or death from any cause. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Time frame: Assessed from the start of study through evidence of hepatic disease progression [Assessed up to 36 months]

  3. Hepatic Objective Response Rate (hORR) as Determined by Imaging Core Lab

    Hepatic Objective Response Rate (hORR), is defined as the proportion of patients with tumor size reduction when evaluating hepatic lesions after study treatment as determined by the IRC using RECIST version 1.1. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Time frame: Assessed from the start of 1st treatment and continues until there is evidence of disease progression in the liver or 1 year from 1st treatment. [Assessed up to 36 months]

  4. Exploratory Analysis for Demographics

    Subgroup analysis of Demographic information, including age, gender, race, and ethnicity. This demographic information is collected for all patients at baseline prior to patients receiving any study treatment. It is collected by the study nurse in conversation with the patient.

    Time frame: At the beginning of screening assessments for baseline data prior to the patient receiving any study drug.

  5. Percentage of Liver Tumor Involvement

    Percentage of liver tumor involvement assessed at baseline with MRI and / or CT imaging and then categorized into two groups: * Extent of liver involvement - 1-25% * Extent of liver involvement - 26-50%

    Time frame: At the beginning of screening assessments for baseline data prior to the patient receiving any study drug.

  6. Performance Status

    Patients will be assessed for performance status based on the ECOG Performance Status (Eastern Cooperative Oncology Group) criteria and the results will be presented in percentage. As the protocol requires that only patients with an ECOG performance status of 0 to 1 be eligible for study treatment, the percentage will be given for these 2 categories. * ECOG performance status 1 * ECOG performance status 2

    Time frame: At the beginning of screening assessments for baseline data prior to the patient receiving any study drug.

07

Results

Posted Sep 10, 2026

Participant flow

The FOCUS Trial was conducted at large academic institutions in the United States and eight European countries.

Participant flow — Overall Study
MilestonePercutaneous Hepatic Perfusion (PHP)
Started102
Safety population95
Completed91
Not completed11

Outcome measures

PrimaryObjective Response Rate (ORR) as Determined by Independent Central Review Committee.

Objective Response Rate (partial or complete) as determined by Independent Central Review Committee. This is assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Time frame:
Patients will be assessed for ORR from baseline through completion of treatment. [assessed up to 36 months].
Reported as:
Number · Percentage of participants
Objective Response Rate (ORR) as Determined by Independent Central Review Committee.
Percentage of participantsPercutaneous Hepatic Perfusion (PHP)
Overall Survival36.3 (26.44 to 47.01)
SecondaryDuration of Response (DOR) as Determined by Independent Central Review Committee

Duration of Response (DOR) is defined as the time from first documented confirmed response of CR or PR based on RECIST v1.1 determined by the IRC to the first documented progression or death due to any cause. This is determined by MRI and / or CT imaging that is conducted every 12 weeks on all patients that started study treatment.

Time frame:
From time of 1st treatment until there is evidence of disease progression [assessed up to 36 months]
Reported as:
Median · months
Duration of Response (DOR) as Determined by Independent Central Review Committee
monthsMelphalan/HDS
Duration of Response (DOR) as Determined by Independent Central Review Committee14.00 (8.31 to 17.74)
SecondaryDisease Control Rate (DCR) Determined by Independent Central Review Committee

DCR is defined as the proportion of patients with a best overall response of CR of any duration, PR of any duration, or stable disease (SD) for a minimum of 12 weeks from the eligibility date for PHP-OCM-301A patients (and randomization date for PHP-OCM-301 patients). This is determined by the evaluation of MRI and / or CT imaging conducted every 12 weeks on all patients that have received study treatment.

Time frame:
ORR will be assessed every 10-14 weeks from the start of 1st treatment and continues until the earlier of either when there is evidence of disease progression or 1 year from 1st treatment up to 12 months.
Reported as:
Number · Percentage of PR + CR
Disease Control Rate (DCR) Determined by Independent Central Review Committee
Percentage of PR + CRMelphalan/HDS
Disease Control Rate (DCR) Determined by Independent Central Review Committee73.6 (63.35 to 82.31)
SecondaryOverall Survival

Overall Survival will be measured from the eligibility date for PHP-OCM-301A patients (and randomization date for PHP-OCM-301 patients) to the date of death (included all-cause mortality).

Time frame:
From the start of the study to the date the patient was last known alive. [assessed up to 36 months]
Reported as:
Median · months
Overall Survival
monthsMelphalan/HDS
Overall Survival20.53 (16.79 to 25.26)
SecondaryProgression-Free Survival

PFS is defined as the time from the eligibility date for PHP-OCM-301A patients (and randomization date for PHP-OCM-301 patients) to the first occurrence of disease progression (either hepatic or extra-hepatic), as determined by the Investigator and / or Independent Central Review Committee assessments using RECIST (version 1.1), or death from any cause. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame:
From start of study until disease progression. [assessed up to 36 months]
Reported as:
Median · months
Progression-Free Survival
monthsMelphalan/HDS
Progression-Free Survival9.03 (6.34 to 11.56)
Other pre-specifiedTime to Objective Response (TOR)

TOR will be assessed and the results for median with 95% confidence intervals using Kaplan-Meier time-to-event analysis techniques will be presented. This is determined by the evaluation of MRI and / or CT imaging conducted every 12 weeks on all patients that have received study treatment.

Time frame:
From study start through study completion. [Assessed up to 36 months]
Reported as:
Median · months
Time to Objective Response (TOR)
monthsTime to Objective Response
Time to Objective Response (TOR)3.29 (2.86 to 5.59)
Other pre-specifiedHepatic Progression Free Survival (hPFS)

Hepatic PFS (hPFS) is defined as the time from the eligibility date for the PHP-OCM-301A patients (and randomization date for PHP-OCM-301 patients) to the first occurrence of hepatic disease progression, as determined by the Independent Central Review Committee (IRC) on imaging studies using RECIST 1.1 or death from any cause. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame:
Assessed from the start of study through evidence of hepatic disease progression [Assessed up to 36 months]
Reported as:
Median · months
Hepatic Progression Free Survival (hPFS)
monthsHepatic Progression-Free Survival (hPFS)
Hepatic Progression Free Survival (hPFS)13.90 (9.30 to 16.66)
Other pre-specifiedHepatic Objective Response Rate (hORR) as Determined by Imaging Core Lab

Hepatic Objective Response Rate (hORR), is defined as the proportion of patients with tumor size reduction when evaluating hepatic lesions after study treatment as determined by the IRC using RECIST version 1.1. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Time frame:
Assessed from the start of 1st treatment and continues until there is evidence of disease progression in the liver or 1 year from 1st treatment. [Assessed up to 36 months]
Reported as:
Number · Participants
Hepatic Objective Response Rate (hORR) as Determined by Imaging Core Lab
ParticipantsHepatic Objective Response Rate (hORR)
Hepatic Objective Response Rate (hORR) as Determined by Imaging Core Lab38
Other pre-specifiedExploratory Analysis for Demographics

Subgroup analysis of Demographic information, including age, gender, race, and ethnicity. This demographic information is collected for all patients at baseline prior to patients receiving any study treatment. It is collected by the study nurse in conversation with the patient.

Time frame:
At the beginning of screening assessments for baseline data prior to the patient receiving any study drug.
Reported as:
Mean · Percentage of liver tumor involvement
Exploratory Analysis for Demographics
Percentage of liver tumor involvementBaseline Extent of Liver Involvement
Exploratory Analysis for Demographics48.94 ± 38.513
Other pre-specifiedPercentage of Liver Tumor Involvement

Percentage of liver tumor involvement assessed at baseline with MRI and / or CT imaging and then categorized into two groups: * Extent of liver involvement - 1-25% * Extent of liver involvement - 26-50%

Time frame:
At the beginning of screening assessments for baseline data prior to the patient receiving any study drug.
Reported as:
Count of participants · Participants
Percentage of Liver Tumor Involvement
ParticipantsBaseline Extent of Liver Involvement < 25%Baseline Extent of Liver Involvement 25% - 50%
Percentage of Liver Tumor Involvement7219
Other pre-specifiedPerformance Status

Patients will be assessed for performance status based on the ECOG Performance Status (Eastern Cooperative Oncology Group) criteria and the results will be presented in percentage. As the protocol requires that only patients with an ECOG performance status of 0 to 1 be eligible for study treatment, the percentage will be given for these 2 categories. * ECOG performance status 1 * ECOG performance status 2

Time frame:
At the beginning of screening assessments for baseline data prior to the patient receiving any study drug.
Reported as:
Count of participants · Participants
Performance Status
ParticipantsEastern Cooperative Group (ECOG) Performance Status 0Eastern Cooperative Group (ECOG) Performance Status 1
Performance Status809

Adverse events

Collected over Serious and Other Adverse Events were collected from first dose until 30 days after last dose (assessed up to June 2021, up to approximately 61 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Melphalan/HDS67/91 (73.6%)43/95 (45.3%)95/95 (100%)
Most frequent serious events
Showing 10 of 53
Most frequent serious events
EventMelphalan/HDS
ThrombocytopeniaBlood and lymphatic system disorders9/95
NeutropeniaBlood and lymphatic system disorders8/95
Febrile neutropeniaBlood and lymphatic system disorders7/95
Platelet count decreasedInvestigations6/95
LeukopeniaBlood and lymphatic system disorders4/95
Cardiac arrestCardiac disorders3/95
Neutrophil count decreasedInvestigations2/95
HypoxiaRespiratory, thoracic and mediastinal disorders2/95
Pleural effusionRespiratory, thoracic and mediastinal disorders2/95
Pulmonary oedemaRespiratory, thoracic and mediastinal disorders2/95
Most frequent other events
Showing 10 of 74
Most frequent other events
EventMelphalan/HDS
AnaemiaBlood and lymphatic system disorders55/95
NauseaGastrointestinal disorders54/95
FatigueGeneral disorders51/95
Platelet count decreasedInvestigations41/95
VomitingGastrointestinal disorders33/95
Alanine aminotransferase increasedInvestigations30/95
International normalised ratio increasedInvestigations29/95
Activated partial thromboplastin time prolongedInvestigations27/95
Aspartate aminotransferase increasedInvestigations27/95
Blood alkaline phosphatase increasedInvestigations26/95

Baseline characteristics

In this trial there were 102 patients enrolled, 95 patients in which a treatment was attempted, and 91 patients that received study drug treatment.

Age, Continuous
Age, Continuous(years)Melphalan/HDS
Enrolled Population58.1 ± 11.45
Safety Population57.7 ± 11.50
Treated Population57.7 ± 11.62
Sex: Female, Male
Sex: Female, Male(Participants)Melphalan/HDS
Female50
Male52
Sex: Female, Male
Sex: Female, Male(Participants)Melphalan/HDS
Female48
Male47
Sex: Female, Male
Sex: Female, Male(Participants)Melphalan/HDS
Female47
Male44
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Melphalan/HDS
Enrolled Population - Race — American Indian or Alaska Native0
Enrolled Population - Race — Asian0
Enrolled Population - Race — Native Hawaiian or Other Pacific Islander0
Enrolled Population - Race — Black or African American0
Enrolled Population - Race — White96
Enrolled Population - Race — More than one race2
Enrolled Population - Race — Unknown or Not Reported4
Safety Population - Race — American Indian or Alaska Native0
Safety Population - Race — Asian0
Safety Population - Race — Native Hawaiian or Other Pacific Islander0
Safety Population - Race — Black or African American0
Safety Population - Race — White90
Safety Population - Race — More than one race2
Safety Population - Race — Unknown or Not Reported3
Treated Population - Race — American Indian or Alaska Native0
Treated Population - Race — Asian0
Treated Population - Race — Native Hawaiian or Other Pacific Islander0
Treated Population - Race — Black or African American0
Treated Population - Race — White86
Treated Population - Race — More than one race2
Treated Population - Race — Unknown or Not Reported3
Age, Categorical
Age, Categorical(Participants)Melphalan/HDS
Enrolled Population - Age — <=18 years0
Enrolled Population - Age — >18 and <65 years69
Enrolled Population - Age — >=65 years33
Safety Population - Age — <=18 years0
Safety Population - Age — >18 and <65 years65
Safety Population - Age — >=65 years30
Treated Population - Age — <=18 years0
Treated Population - Age — >18 and <65 years61
Treated Population - Age — >=65 years30
08

Study locations

22 sites
  • University of Arizona
    Tucson, Arizona 85719, United States
  • Stanford University
    Palo Alto, California 19380, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Ohio State University James Cancer Center
    Columbus, Ohio 43210, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • University of Tennessee Health Science Center
    Memphis, Tennessee 38163, United States
  • Universitätsklinikum Graz
    Graz, 8036, Austria
  • Universitair Ziekenhuis Leuven
    Leuven, 3000, Belgium
  • Centre Léon Bérard
    Lyon, Rhône 69373, France
  • Charité Unversitätsmedizin Berlin Comprehensive Cancer Center
    Berlin, 10117, Germany
  • Universitätsklinikum Giessen und Marburg
    Marburg, 35043, Germany
  • Universitätshautklinik Münster
    Münster, Germany
  • Universitätsklinikum Regensburg
    Regensburg, 93053, Germany
  • Universitätsklinikum Würzburg
    Würzburg, 97080, Germany
  • Istituto Europeo di Oncologia
    Milan, 20141, Italy
  • Clínic Barcelona
    Barcelona, 08036, Spain
  • UniversitätsSpital Zürich
    Zurich, 8091, Switzerland
  • University Hospital Southampton NHS Trust
    Southampton, Hampshire SO16 6YD, United Kingdom
  • Aintree University Hospital
    Liverpool, L9 7AL, United Kingdom
09

References and documents

Publications

  • Zager JS, Orloff M, Ferrucci PF, Choi J, Eschelman DJ, Glazer ES, Ejaz A, Howard JH, Richtig E, Ochsenreither S, Reddy SA, Lowe MC, Beasley GM, Gesierich A, Bender A, Gschnell M, Dummer R, Rivoire M, Arance A, Fenwick SW, Sacco JJ, Haferkamp S, Weishaupt C, John J, Wheater M, Ottensmeier CH. Efficacy and Safety of the Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study. Ann Surg Oncol. 2024 Aug;31(8):5340-5351. doi: 10.1245/s10434-024-15293-x. Epub 2024 May 4. PubMed 38704501 ↗

Study documents

  • Study protocol · Jun 22, 2018
  • Statistical analysis plan · Jun 18, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02678572
Lead sponsor
Delcath Systems Inc.
Collaborators
IQVIA Biotech
Responsible party
Sponsor
First posted
Feb 10, 2016
Start date
Feb 1, 2016
Primary completion
May 18, 2023
Completion
Aug 15, 2023
Results posted
Sep 10, 2026
Last update
Sep 10, 2026

Study contacts

Jonathan Zager, MD
principal investigator · Moffitt Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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