drugset / Trial / NCT00112242
Immunotherapy of Stage III/IV Melanoma Patients
Phase 1
Completed
39 enrolled
Centre Hospitalier Universitaire Vaudois
Ludwig Institute for Cancer Research · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether vaccination with melanoma antigen peptides \[Melan-A/Mart-1 (both EAA and ELA), NY-ESO-1b analog, Long NY-ESO-1 LP and MAGE-A10\] and Montanide, CpG adjuvants and low dose rIL-2 can induce an immune response in melanoma patients and to assess the safety of this vaccination.
Timeline
- Start
- 2004-02
- Primary completion
- 2013-03
- Completion
- 2013-03
Publications
- Results Baumgaertner P, Costa Nunes C, Cachot A, Maby-El Hajjami H, Cagnon L, Braun M, Derre L, Rivals JP, Rimoldi D, Gnjatic S, Abed Maillard S, Marcos Mondejar P, Protti MP, Romano E, Michielin O, Romero P, Speiser DE, Jandus C. Vaccination of stage III/IV melanoma patients with long NY-ESO-1 peptide and CpG-B elicits robust CD8+ and CD4+ T-cell responses with multiple specificities including a novel DR7-restricted epitope. Oncoimmunology. 2016 Sep 9;5(10):e1216290. doi: 10.1080/2162402X.2016.1216290. eCollection 2016.
- Results Hebeisen M, Schmidt J, Guillaume P, Baumgaertner P, Speiser DE, Luescher I, Rufer N. Identification of Rare High-Avidity, Tumor-Reactive CD8+ T Cells by Monomeric TCR-Ligand Off-Rates Measurements on Living Cells. Cancer Res. 2015 May 15;75(10):1983-91. doi: 10.1158/0008-5472.CAN-14-3516. Epub 2015 Mar 25.
- Results Bordry N, Costa-Nunes CM, Cagnon L, Gannon PO, Abed-Maillard S, Baumgaertner P, Murray T, Letovanec I, Lazor R, Bouchaab H, Rufer N, Romano E, Michielin O, Speiser DE. Pulmonary sarcoid-like granulomatosis after multiple vaccinations of a long-term surviving patient with metastatic melanoma. Cancer Immunol Res. 2014 Dec;2(12):1148-53. doi: 10.1158/2326-6066.CIR-14-0143. Epub 2014 Oct 2.
- Costa-Nunes C, Cachot A, Bobisse S, Arnaud M, Genolet R, Baumgaertner P, Speiser DE, Sousa Alves PM, Sandoval F, Adotevi O, Reith W, Protti MP, Coukos G, Harari A, Romero P, Jandus C. High-throughput Screening of Human Tumor Antigen-specific CD4 T Cells, Including Neoantigen-reactive T Cells. Clin Cancer Res. 2019 Jul 15;25(14):4320-4331. doi: 10.1158/1078-0432.CCR-18-1356. Epub 2019 Apr 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MAGE-A10 | Peptide | 0.1 mg | — |
| Subject | MAGE-A10 | Peptide | 0.5 mg | — |
| Subject | Melan-A EAA | Peptide | 0.1 mg | — |
| Subject | Melan-A ELA | Peptide | 0.1 mg | — |
| Subject | Melan-A ELA | Peptide | 0.5 mg | — |
| Subject | NY-ESO-1 lp | Unknown | 0.5 mg | Subcutaneous |
| Subject | NY-ESO-1b | Peptide | 0.5 mg | — |
| Subject | agatolimod | Oligonucleotide (other) | 2.5 mg | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | — | — |
| Background | Montanide | Other / unclassified | 1 ml | Subcutaneous |