Clinical trial · Interventional
Toll-like Receptor (TLR) Ligand Matured Dendritic Cell Vaccination in Melanoma Patients
TLR Ligand Matured Dendritic Cell Vaccination in Melanoma Patients: the Key Towards a More Potent Immune Induction?
- 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)
Objectives: This is an exploratory study, consisting of two parts. In part I a dose escalation is performed and the primary objective is the safety of different doses of TLR-dendritic cell (TLR-DC). In part II TLR-DC vaccination will be compared with cytokine-matured DC vaccination and the primary objective of this part is the immunological response to TLR-DC vaccination, with toxicity and clinical efficacy being secondary objectives. These studies will provide important data on the safety and immunological effects of TLR-matured DC. Study design: This study is an open label prospective exploratory intervention study. Study population: The investigators' study population consists of HLA-A2.1 positive melanoma patients, with proven expression of melanoma associated tumor antigens gp100 and tyrosinase. Melanoma patients with regional lymph node metastasis in whom a radical lymph node dissection is planned or performed within 2 months of inclusion in this study (further referred to as stage III) and melanoma patients with measurable distant metastases (further referred to as stage IV) will be included.
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 | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous dendritic cell vaccination | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- cytokine matured DC
- description
- vaccination with autologous dendritic cells matured with standard cytokine cocktail and electroporated with mRNA encoding tumor associated antigens
- interventionNames
- Biological: autologous dendritic cell vaccination
- type
- EXPERIMENTAL
- label
- TLR ligand matured DC
- description
- vaccination with autologous TLR-ligand matured dendritic cells electroporated with mRNA encoding tumor associated antigens
- interventionNames
- Biological: autologous dendritic cell vaccination
Primary outcomes (1)
- measure
- Toxicity of TLR-matured DC (part I) and immunological response upon vaccination with TLR-matured DC (part II)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: All patients: * histologically documented evidence of melanoma * stage III or IV melanoma according to the 2001 AJCC criteria * HLA-A2.1 phenotype melanoma expressing gp100 (compulsory) and tyrosinase (non- compulsory) * WHO performance status 0-1 (Karnofsky 100-70) * life expectancy \> 3 months * age 18-70 years * no clinical signs or symptoms of CNS metastases * WBC \> 3.0x109/l, lymphocytes \> 0.8x109/l, platelets \> 100x109/l, serum creatinine \< 150 µmol/l, serum bilirubin \< 25 µmol/l * normal serum LDH (\< 450 U/l) * expected adequacy of follow-up * no pregnant or lactating women * written informed consent And in addition for Part I + II: * stage III melanoma: radical regional lymphnode dissection is planned or performed * stage IV melanoma: at least one unidimensional measurable target lesions according to RECIST, not previously irradiated, and no significant symptoms of disease requiring other palliative treatments Exclusion Criteria: * prior chemotherapy, immunotherapy or radiotherapy \< 4 weeks prior to planned vaccination or presence of treatment-related toxicity * history of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix serious active infections, HbsAg or HIV positive or autoimmune diseases or organ allografts * concomitant use of immunosuppressive drugs * known allergy to shell fish (since it contains KLH) * rapidly progressive disease * any serious clinical condition that may interfere with the safe administration of DC
References
Publications (0)
Data not yet available