Clinical trial · Interventional
Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides
NCT02429440CI-TRIAL-00029125UroRCCunknownPhase 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)
Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer (RCC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Granulocyte Macrophage Colony Stimulating Factor | Drug | — | UNRESOLVED |
| Montanide ISA-51 | Drug | — | UNRESOLVED |
| peptide vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study Arm 1
- description
- Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
- interventionNames
- Biological: peptide vaccine
- Drug: Granulocyte Macrophage Colony Stimulating Factor
- type
- ACTIVE_COMPARATOR
- label
- Study Arm 2
- description
- Intradermal application of peptide vaccine with Montanide ISA-51
- interventionNames
- Biological: peptide vaccine
- Drug: Montanide ISA-51
Primary outcomes (1)
- measure
- Tolerability
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced renal cell carcinoma clinical stage T3 or T4, N0, M0 * N+, M0 * M1 (after complete metastasectomy) * ECOG performance status 0 or 1 * age \>18 years * at least 4 weeks since last administration of radiation- or chemotherapy * Serum levels of bilirubin \<2 mg/dl, creatinine\<2mg/dl Exclusion Criteria: * detectable distant metastasis in radiological imaging (M1) * patients unable to consent * severe cardiopulmonary disorder (NYHA \>= 3) * presence of secondary malignancy * Immunosuppressive medication (last application of glucocorticoids \> 4 weeks) * seizure * pregnancy * simultaneous participation in other active or passive immunisation treatment
References
Publications (0)
Data not yet available
No reference posted for this study.