Clinical trial · Interventional
Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)
Phase I Clinical Trial of a Therapeutic Vaccine for Malignancies, Comprising the Tumor Antigen NY-ESO-1 in Combination With the Adjuvant MPLA of Bordetella Pertussis. Evaluation of Toxicity and Immunogenicity
NCT01584115CI-TRIAL-00006783unknownPhase 1 / Phase 2ClinicalTrials.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)
This study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability, immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined with the adjuvant MPLA from B. pertussis in cancer patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer. | Malignant Neoplasm | ALIAS | 0.90 |
| Lung Cancer. | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma. | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer. | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NY-ESO-1 combined with MPLA | Biological | — | UNRESOLVED |
| NY-ESO-1 combined with MPLA vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NY-ESO-1
- description
- NY-ESO-1 combined with MPLA vaccine
- interventionNames
- Biological: NY-ESO-1 combined with MPLA
- Biological: NY-ESO-1 combined with MPLA vaccine
Primary outcomes (1)
- measure
- Safety
- timeFrame
- Six months after immunization.
- description
- CTCAE (Common Terminology Criteria for Adverse Events)
Secondary outcomes (1)
- measure
- Immunogenicity
- timeFrame
- Six months after immunization.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * In this study, will be included fifteen patients aged over 18 years, with a confirmed diagnosis of malignant neoplasms, which have proven NY-ESO-1 expression by immunohistochemistry and have undergone the standard treatment. Exclusion Criteria: * Will be excluded from the study patients with continuous use of systemic steroids, immunosuppressive agents and antibiotics, and with severe chronic systemic disease.
References
Publications (0)
Data not yet available
No reference posted for this study.