Clinical trial · Interventional
Single-step Antigen Loading and TLR Activation of Dendritic Cells in Melanoma Patients
Single-step Antigen Loading and TLR Activation of Dendritic Cells by mRNA Electroporation for Vaccination in Stage III and IV Melanoma Patients
- 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 dose escalation is performed and the primary objective is the safety of different doses of TLR-DC and Trimix DC. In part II Trimix DC vaccination will be compared with TLR-DC vaccination and the primary objective of this part is the immunological response, with toxicity and clinical efficacy being secondary objectives. These studies will provide important data on the safety and immunological effects of TLR-DC and Trimix DC. Study design: Part I of this study is an open label dose escalation study. Part II of this study is an open label randomized phase II study. Study population: Our study population consists of 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 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 vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- single step DC treatment
- description
- vaccination with autologous dendritic cells treated with mRNA electroporation for single-step antigen loading and TLR activation (TriMix-DC)
- interventionNames
- Biological: autologous dendritic cell vaccine
- type
- ACTIVE_COMPARATOR
- label
- two step DC treatment
- description
- vaccination with autologous dendritic cells treated with mRNA electroporation for antigen loading and separately for TLR activation
- interventionNames
- Biological: autologous dendritic cell vaccine
Primary outcomes (2)
- measure
- The primary objective of the study isto investigate immunological responses upon vaccination
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 * 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 \> 3.0x10e9/l, lymphocytes \> 0.8x10e9/l, platelets \> 100x10e9/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 (Stage III melanoma) * radical regional lymphnode dissection is 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 symptomatic disease * any serious clinical condition that may interfere with the safe administration of DC
References
Publications (0)
Data not yet available