Observational Study of Cabozantinib and Nivolumab as First-Line Therapy for Advanced or Metastatic Renal Cell Carcinoma

Renal cell carcinoma (RCC) is a malignant disease characterized by the uncontrolled proliferation of certain kidney cells (tubular cells). These cells are responsible, among other things, for filtering urine. The disease is usually asymptomatic in its early stages. For this reason, the cancer is often discovered by chance or only at an advanced or metastatic stage. Cancer is considered metastatic when cancer cells are already detectable as distant metastases in other organ systems. The combination therapy of cabozantinib and nivolumab is already approved as a first-line treatment for advanced or metastatic renal cell carcinoma. Nivolumab is a so-called PD-1 inhibitor—an antibody that binds to the PD-1 surface protein on immune cells and neutralizes the inhibitory effect of the PD-1 ligand/PD-1 receptor system. As a result, cancer cells are no longer able to deactivate the body’s own immune cells and can be destroyed by the immune system. Cabozantinib is a tyrosine kinase inhibitor (TKI) that blocks enzymes to inhibit the signaling pathways and growth of cancer cells. This combination of immunotherapy and targeted therapy is necessary because renal cell carcinoma is generally resistant to chemotherapy, and surgical removal is often no longer possible at this stage. Cabozantinib and nivolumab are also approved as monotherapies; the decision to use monotherapy or combination therapy depends on various factors, such as the patient’s health status.

The aim of this prospective observational study is to document the efficacy and tolerability of monotherapy with cabozantinib or combination therapy with cabozantinib and nivolumab in everyday clinical practice. In particular, the study will record dose reductions and interruptions or delays in medication intake due to side effects of the therapy. “Prospective” means that the patients’ disease progression will be monitored over a certain period of time (in this case, 2 years). Participation in the study does not involve any additional treatment, nor is any new medication being tested.

Women and men aged 18 and older with advanced or metastatic renal cell carcinoma are eligible to participate in this study. Patients must have already decided to undergo treatment with cabozantinib or the combination therapy of cabozantinib and nivolumab before beginning their participation.