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AzTrials

Melanoma, Uveal MetastaticPhase 1NCT04335890

IKKb-matured, RNA-loaded Dendritic Cells for Metastasised Uveal Melanoma

A Phase 1 study testing Vaccination with IKKb matured Dendritic Cells in people with Melanoma, Uveal Metastatic, run by Hasumi International Research Foundation at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Melanoma, Uveal Metastatic
What is being tested?
Vaccination with IKKb matured Dendritic Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteGermany
Study dates
24 Sep 2020to 30 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Major serious illness
  • evidence for HIV-1, HIV-2, HTLV-1, HBV or HCV infection
  • active autoimmune disease requiring immunosuppressive therapy
  • splenectomy or radiation therapy of the spleen
  • organ allografts
  • pregnancy
Show all 9Show fewer
  • lactation
  • psychiatric disorders
  • severe organic brain syndrome

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Erlangen Dept. of Dermatology

    Erlangen, Bavaria, 91054

Other trials in Germany

About this study

Official title: 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

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).

Read the detailed description

Intravenous infusion of 7.5 to 30 mio DCIKKb at 9 vaccination time points (week 1, 3, 7, 13, 19, 25, 31, 37 and 42) and in intervals of 2, 4, and 6 intervals of 6 weeks) is scheduled; the first 4 patients will receive reduced doses for the first 4 vaccinations, namely 7.5 mio (1st and 2nd vaccination) and 15 mio (3rd and 4th vaccination) DC followed by the full dose of 30 mio for subsequent vaccinations. Patients number 5 to 8 will receive initially reduced doses of 15 mio (1st and 2nd vaccination) DC for the first 2 vaccinations, and the full dose of 30 mio for subsequent vaccinations. Patients number 8 to 12 will receive the full dose of 30 mio cells from vaccination 1 onwards provided that no major side effects occurred. Patients will be vaccinated in a staggered approach by selectively decelerating release of the vaccine.

DCIKKb = autologous, monocyte-derived DC that are matured with the standard cocktail (TNF-alpha, IL-1 beta, IL-6 and PGE2) and IKKb-RNA loaded by electroporation with 1) autologous PCR-amplified total tumor mRNA, 2) RNA coding for defined tumor associated antigens (TAA) namely gp100, tyrosinase, PRAME, MAGE-A3, IDO) and 3) RNA coding for driver mutations (GNAQ/GNA11Q209 or R183, or the less frequently occurring SF3B1R625, CYSLTR2L129Q or PLCB4D630) by electroporation; RNAs for selected TAAs are in stock and will be transfected into the DCs only if expressed in the individual tumor of a patient (shown by RNA sequencing of the tumor); RNAs for selected driver mutations are in stock and will be loaded into the DCs only if the respective mutation is found (proven by exome and RNA sequencing) in the individual tumor.

Being tested
Vaccination with IKKb matured Dendritic Cells
Keywords
local treatment not sufficient, systemic treatment indicated
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaccination with IKKb matured Dendritic CellsBiological

    Also called Dendritic Cell vaccine

    IKKb matured autologous monocyte derived dendritic cells loaded with RNAs; intravenous Infusion with a dose escalation starting with 7.5 mio Dendritic Cells for the first vaccination up to 30 mio cells per vaccination

Study groups in NCT04335890
Study groupRoleWhat they receive
DC IKKbExperimentalVaccination with IKKb matured RNA loaded Dendritic Cells
Receives: Biological: Vaccination with IKKb matured Dendritic Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of DCIKKb

    Assesment of side effects using the Common Toxicity Criteria (CTC v4.0)

    Measured: 1 year

  2. Tolerability of DCIKKb

    Assesment of Quality of life using Quality of life EORTC QLQ-C30, Version 2

    Measured: 1 year

  3. Dose-limiting toxicities (DLTs) of DCIKKb

    Assesment of side effects using the Common Toxicity Criteria (CTC v4.0)

    Measured: 1 year

  4. Maximum tolerated dose (MTD) of DCIKKb

    Assesment of side effects using the Common Toxicity Criteria (CTC v4.0)

    Measured: 1 year

Secondary outcomes (3)

  1. Prolongation of median overall survival

    Assesment of survival

    Measured: 2 years

  2. Prolongation of overall survival (OS) after 1 and 2 years

    Assesment of survival

    Measured: 2 years

  3. Induction of antigen specific CD8+ T cells and / or CD4+ T cells against TAA and mutated drivers

    Assesment of immune responses

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2020
  2. Study start24 Sep 2020
  3. Primary completion20 Sep 2022
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04335890
Sponsor's protocol ID
DERMA-ER-DC 09
Status last verified
Oct 2025
First submitted
1 Apr 2020
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pfeiffer IA, Hoyer S, Gerer KF, Voll RE, Knippertz I, Guckel E, Schuler G, Schaft N, Dorrie J. Triggering of NF-kappaB in cytokine-matured human DCs generates superior DCs for T-cell priming in cancer immunotherapy. Eur J Immunol. 2014 Nov;44(11):3413-28. doi: 10.1002/eji.201344417. Epub 2014 Sep 16.

    PubMed 25100611

  • Gerer KF, Erdmann M, Hadrup SR, Lyngaa R, Martin LM, Voll RE, Schuler-Thurner B, Schuler G, Schaft N, Hoyer S, Dorrie J. Preclinical evaluation of NF-kappaB-triggered dendritic cells expressing the viral oncogenic driver of Merkel cell carcinoma for therapeutic vaccination. Ther Adv Med Oncol. 2017 Jul;9(7):451-464. doi: 10.1177/1758834017712630. Epub 2017 Jun 13.

    PubMed 28717398

  • Schuler-Thurner B, Bartz-Schmidt KU, Bornfeld N, Cursiefen C, Fuisting B, Grisanti S, Heindl LM, Holbach L, Keseru M, Knorr H, Koch K, Kruse F, Meiller R, Metz C, Meyer-ter-Vehn T, Much M, Reinsberg M, Schliep S, Seitz B, Schuler G, Susskind D, Viestenz A, Wagenfeld L, Zeschnigk M. [Immunotherapy of uveal melanoma: vaccination against cancer. Multicenter adjuvant phase 3 vaccination study using dendritic cells laden with tumor RNA for large newly diagnosed uveal melanoma]. Ophthalmologe. 2015 Dec;112(12):1017-21. doi: 10.1007/s00347-015-0162-z. German.

    PubMed 26602097

  • Koch EAT, Schaft N, Kummer M, Berking C, Schuler G, Hasumi K, Dorrie J, Schuler-Thurner B. A One-Armed Phase I Dose Escalation Trial Design: Personalized Vaccination with IKKbeta-Matured, RNA-Loaded Dendritic Cells for Metastatic Uveal Melanoma. Front Immunol. 2022 Feb 4;13:785231. doi: 10.3389/fimmu.2022.785231. eCollection 2022.

    PubMed 35185883

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vaccination with IKKb matured Dendritic Cells in people with Melanoma, Uveal Metastatic, run by Hasumi International Research Foundation at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of DCIKKb (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04335890, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

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