Clinical trial · Interventional
Phase II Study With Immunotherapy With Dendritic Cells and Tumor Infiltrating Lymphocytes in Solid Tumors
- 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)
Background: cellular immunotherapy with dendritic cells (DC) loaded with tumor antigens has shown clinical activity, although in a small number of patients. Therefore, is is mandatory to improve the results of this strategy and to closely monitor immunologic response and cell migration in order to improve our understanding of mechanisms of action and to settle future fields of development.. Objectives: Primary: to confirm clinical activity of this strategy, determining tumor response (RECIST criteria). Secondary: to determine: (1) safety; (2) antitumoral immune response and (3) DC migration in the organism Methodology: phase II trial in patients with advanced renal cell carcinoma and melanoma. We will perform repeated immunizations with DC loaded with the patient´s tumor.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immunotherapy with dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Biological: immunotherapy with dendritic cells
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 2 months
Secondary outcomes (1)
- measure
- Immunological response
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of metastatic melanoma, renal cell carcinoma, or hepatocarcinoma (Child´s stage A or B) not amenable of curative treatment. For patients with hepatocarcinoma, treatment after embolization is allowed * Measurable disease * ECOG 0, 1 or 2. * Adequate renal, hepatic and bone marrow function * Availability of tumor tissue, for maturing dendritic cells Exclusion Criteria: * Clinically relevant diseases or infections. * concurrent participation in other clinical trial or administration or other antitumoral treatment * Concurrent cancer, with the exceptions allowed by the PI. * Pregnant or breast feeding women * immunosuppressant treatment * known CNS metastasis
References
Publications (0)
Data not yet available