Based on promising efficacy findings, the COSMIC-021 clinical trial has been expanded from the original two indications (non-small cell lung cancer (NSCLC) and prostate cancer) and is now open to patients with renal cell carcinoma (RCC), urothelial cancer, breast cancer and ovarian cancer.
The phase 1b, open-label trial assesses the combination of cabozantinib (Cabometyx) and atezolizumab (Tecentriq) in people with locally advanced or metastatic solid tumours.
The trial is evaluating the safety, tolerability, efficacy, and pharmacokinetic properties (how a drug is absorbed, distributed, metabolised, and eliminated) of cabozantinib in combination with atezolizumab in patients with different types of solid cancers.
The study is divided into two phases. The first phase (dose-escalation phase) is now complete and helped to determine the optimal dose of cabozantinib (40 mg daily) and atezolizumab (1,200 mg infusion once every three weeks) in patients with advanced RCC or locally advanced, metastatic or recurrent urothelial cancer.
The second phase (expansion phase) is now assessing the percentage of patients with RCC, urothelial cancer, NSCLC, prostate cancer, breast cancer and ovarian cancer responding to the combination therapy.
The two original groups of patients (NSCLC and prostate cancer) have been expanded from 30 to 80 patients each and will receive the optimal doses of the combination therapy.
The Barts Cancer Institute in London is recruiting patients for this study.