Phase II Randomized Double-Blind Trial of PF-04518600, an OX40 Antibody, in Combination with Axitinib Versus Axitinib in Immune-Checkpoint Inhibitor Exposed Patients with Metastatic Renal Cell Carcinoma

Patients with the most common type of kidney cancer are initially treated with VEGF targeting drugs such as sunitinib and pazopanib, among others. Once the cancer develops resistance, the treatment is changed to an anti PD1/PDL1 immunotherapy with drugs such as nivolumab. Unfortunately, no treatment strategy works forever and inevitably there is a need to change treatment once again. Patients who have had both VEGF targeting drugs and immunotherapy are typically treated with another VEGF targeting agent, although no drug has been found to provide the best outcome in this setting. This study proposes to give such patients axitinib. In addition, this study proposes to investigate whether the addition of an experimental drug, also working on the immune system, would improve the outcomes for patients. Since this is an experiment and the experimental drug is not proven to be effective, half of the patients will receive the experimental drug, i.e. OX40-Ab and the other half will receive placebo. The treatment assignment is decided at random. The OX40-Ab was studied in various cancers and was found to be safe. If you, or a loved one, has advanced (metastatic, stage IV, or unresectable) kidney cancer and have been treated with anti PD1/PDL1 immunotherapy in the past, this trial may be a treatment option.

Keywords: Metastatic kidney cancer, metastatic renal cell carcinoma, axitinib, OX40 Antibody