Clinical trial · Interventional
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
NCT04335890CI-TRIAL-00104626completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma, Uveal Metastatic | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vaccination with IKKb matured Dendritic Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DC IKKb
- description
- Vaccination with IKKb matured RNA loaded Dendritic Cells
- interventionNames
- Biological: Vaccination with IKKb matured Dendritic Cells
Primary outcomes (4)
- measure
- Safety of DCIKKb
- timeFrame
- 1 year
- description
- Assesment of side effects using the Common Toxicity Criteria (CTC v4.0)
- measure
- Tolerability of DCIKKb
- timeFrame
- 1 year
- description
- Assesment of Quality of life using Quality of life EORTC QLQ-C30, Version 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * lactation * psychiatric disorders * severe organic brain syndrome
References
Publications (4)
- RESULTPfeiffer 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. PMID 25100611
- RESULTGerer 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. PMID 28717398
- RESULTSchuler-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. PMID 26602097
- DERIVEDKoch 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. PMID 35185883