Trial · NCT05022901
An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma
NCT05022901, Phase 3, Active not recruiting, Delcath Systems Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma. Trials, record NCT05022901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05022901
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma
- NCT number
- NCT05022901
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Delcath Systems Inc.
- Conditions
- Metastatic Ocular Melanoma, Metastatic Uveal Melanoma
- Interventions
- Melphalan (3 mg/kg IBW) with Hepatic Delivery System (HDS)
- First posted
- 2021-08-26
- Last updated
- 2023-12-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | From eligibility until death due to any cause, for up to 104 weeks | The number and type of adverse events will be assessed per CTCAE version 5.0. |
| Secondary | Efficacy (ORR) | Every 12 (+/-2) weeks until progression, for up to 104 weeks | Defined as the proportion of patients with a best overall response (BOR) based on a confirmed complete response or partial response (CR+PR) determined by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). |
| Secondary | Efficacy (OS) | From eligibility until death due to any cause, for up to 104 weeks | The time from the eligibility date to date of death due to any cause |
| Secondary | Efficacy (PFS) | Every 12 (+/-2) weeks until progression, for up to 104 weeks | The time from the eligibility date to the first documented progression or death due to any cause determined by the investigator |
| Secondary | Quality of Life (FHSI-8) | Every 6-8 weeks until the end of treatment, for up to 52 weeks | FHSI-8 Quality of Life Survey |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05022901
GET https://conductscience.org/api/trials/v1/NCT05022901/registered