NCT04335890CompletedPhase 1
IKKb-matured, RNA-loaded Dendritic Cells for Metastasised Uveal Melanoma
Phase I Vaccination Trial in Metastatic Uveal Melanoma Using IKKb-matured Dendritic Cells Loaded With Autologous Tumor-RNA + RNA Coding for Defined Antigens and Driver Mutations
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
A Phase I vaccination trial in patients suffering from recently diagnosed metastatic uveal melanoma not cureable with local therapy and needing systemic therapy. IKKb-matured Dendritic Cells loaded with autologous tumor-RNA + RNA coding for defined antigens and driver mutations will be added to a standard therapy chosen by the tumor board (either checkpoint blockade or chemotherapy).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 1 Apr 2020
- Start date
- 24 Sept 2020
- Primary completion date
- 20 Sept 2022
- Lead sponsor
- Hasumi International Research Foundation
- Diseases
- Melanoma
- NCT number
- NCT04335890
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 17
- From 24 Sept 2020 to the primary completion date, 20 Sept 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- splenectomy or radiation therapy of the spleen
Other illness
- Major serious illness
- evidence for HIV-1, HIV-2, HTLV-1, HBV or HCV infection
- active autoimmune disease requiring immunosuppressive therapy
- psychiatric disorders
- severe organic brain syndrome
Other
- organ allografts
- pregnancy
- lactation
Who the study is looking for
- Histologically confirmed unresectable stage IV metastatic uveal melanoma as per AJCC staging system 2014, 7th edition (updated 2018) not curable with local therapy modalities
- WHO performance status of 0, 1 or 2
- age from 18 and ≤ 75 years
- negative pregnancy test
- signed informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Erlangen Dept. of Dermatology Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.