Table 1.
Completed clinical trials of therapeutic vaccines in renal cell carcinoma (localized: RCC or metastatic: mRCC)
| Vaccine developer | Phase | Patients (N) | TAA or vaccine type | Vector | Combined with | Notes | Reference |
|---|---|---|---|---|---|---|---|
| Reniale LipoNova, Hannover, Germany | III | 379* RCC | Tumor lysate | None | 0 | Endpoint: Tumor progression risk (NS) Subgroups: pT3 and G3 better 5 and 10-y PFS Strong methodological bias | [46–47] |
| TroVax Oxford Biomedica, Oxford, UK | III | 733 mRCC | 5T4 | Modified Ankara virus | IFNα, IL2, or sunitinib | Endpoint: OS (NS) Subgroup Immune responders with normal hemogram: higher OS | NCT00397345 [48–50] |
| Vitespen (formerly Oncophage) Agenus (formerly Anti-genics),Lexington, USA | II II III | 818 RCC | gp96 HSP-peptide complex (HSPPC-96) | None | 0 | Endpoint: RFS (NS) Subgroup: Stage I & II: NS decrease in recurrence Marketed in Russia | NCT01147536 NCT00126178 NCT00033904 [51] |
| TG4010 Transgene, Illkirch-Graffenstaden, France | II | 37 mRCC | MUC1 | None | ± cyto-kines | Endpoint: Clinical response (NS) | [52] |
| AGS-003 Argos Therapeutics Durham, NC, USA | II | 21 mRCC | Tumor mRNA (+CD40L) | DC | Sunitinib | Good safety | NCT00678119 [53-54] |
| IMA-901 Immatics Bio-technologies, Tübingen, Germany | II | 30+68 mRCC | 10 peptides* | Adjuvant: GM-CSF | 0 | Subgroup benefit: Immune response (multi-TUMAP responder) | NCT00523159 [21] |
| DC-vaccines | Meta-analysis (n = 12) | 148 mRCC | DC | DC | 0 | ORR 12.7%, CBR 48% Subgroup benefit: Immune response and High dose DC | (55) |
379 eligible patients for assessment (intention to treat) on 558 enrolled.
Abbreviations: CBR, clinical benefit rate; DC, dendritic cells; GM-CSF, granulocyte macrophage colony-stimulating factor; HSP, heat-shock protein; NS, not significant; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; RCC, renal cell carcinoma; TAA, tumor associated antigen; TUMAP, tumor associated peptide
These are APO-001, PLIN2 and APOL1 (overexpressed in lipid droplets in RCC);91 CCND1 (modified cell cycle regulator showing aberrations in RCC); 92 GUCY1A3 ( involved in cGMP synthesis and angiogenic in RCC); 93 PRUNE2 (overexpressed in RCC); 94 MET (hepatocyte growth factor receptor); 95 RGS (cell cycle regulator involved in angiogenesis); 96 MUC1 (cell surface glycoprotein with modified glycosylation pattern in tumors leading to potential antigens (e.g., CA15-3); MMP7 (involved in invasion and metastasis). 97