Table 2:
Ongoing clinical trials of immunotherapies for mesothelioma
| Intervention | Study design | Estimated enrolment (n) | Stage and disease | Main eligibility requirements | Endpoints | |
|---|---|---|---|---|---|---|
| Adjuvant WT1 analogue peptide vaccine | WT1 analogue peptide vaccine, montanide, granulocyte macrophage colony-stimulating factor, or montanide adjuvant, granulocyte macrophage colony-stimulating factor | Phase 2 randomised, double-blind | 78 | Mesothelioma | Immunohistochemistry positive for WT1 (>10% of cells). Completed combined modality therapy* | Primary: 1 year PFS. Secondary: immunogenicity |
| Dendritic cell vaccine, cyclophosphamide | Tumour lysate autologous dendritic cells, cyclophosphamide | Phase 1 | 10 | Mesothelioma | Stable disease or objective response after chemotherapy. Availability of sufficient tumour material | Primary: immunogenicity. Secondary: safety |
| Tumour cell vaccine, adjuvant, and celecoxib | Epigenetically modifi ed autologous tumour cell vaccine, ISCOMATRIX™ adjuvant, postoperative celecoxib | Phase 1 | 120 (30 assessable) | Mesothelioma and other malignancies† | Completed surgical resection plus adjuvant chemotherapy or radiation, or both | Primary: safety. Secondary: immunogenicity |
| Tumour cell vaccine, cyclophosphamide,and celecoxib | Allogeneic tumour cell vaccine, metronomic low-dose cyclophosphamide, celecoxib | Phase 1 and 2 | 25 | Thoracic malignancies | No evidence of disease or minimal residual disease after standard multimodality therapy | Primary: safety. Secondary: immunogenicity |
PFS=progression-free survival.
Combined modality therapy: surgical resection plus chemotherapy or radiation, or both.
Lung and oesophageal carcinoma or sarcoma.