Exelixis announced today the start of a phase 1b clinical trial of cabozantinib in combination with atezolizumab (TECENTRIQ®) in patients with locally advanced or metastatic urothelial carcinoma (UC) or renal cell carcinoma (RCC).
The primary objective of this study is to determine the best dose and dosing schedule of cabozantinib when given in combination with atezolizumab. The best dose found in the first part of this trial (the dose-escalation stage) will be used in the second part of the trial (the expansion stage) to look at how effective the cabozantinib plus atezolizumab combination is against inoperable, locally advanced, metastatic or recurrent UC (including renal, pelvis, ureter, urinary bladder and urethra), or RCC patients who have not received prior systemic therapy. Between 9 to 36 patients will be included in the first stage of the trial, and up to 120 patients will be included in the second stage (4 cohorts of 30 patients in each cohort).
Both parts of the trial will assess the safety of the cabozantinib plus atezolizumab combination through the evaluation of incidence and severity of side effects, including immune-related adverse events.
The trial is being conducted by researchers at the City of Hope Hospital in California, USA. “Patients with locally advanced or metastatic urothelial or renal cell carcinoma are in need of additional therapies that can slow disease progression,” said Dr Sumanta Kumar Pal, Co-director, Kidney Cancer Program at City of Hope, and Principal Investigator of the study. “As new investigational and approved therapies become available, research into their use in combination with other treatments may be a productive avenue for improving clinical outcomes in patients with these tumour types. Identifying the appropriate dose for cabozantinib when paired with the immunotherapy atezolizumab is the first step in examining this potential combination therapy.”
More information about this trial is available at ClinicalTrials.gov.