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Thomas Flaig, MD


Phase III Trial to Combine Maintenance Avelumab and Cabozantinib in Metastatic Urothelial Cancer

By: Hope Craig, MSPH
Posted: Friday, July 22, 2022

At the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS4607), Shilpa Gupta, MD, of the Taussig Cancer Institute, Cleveland Clinic Foundation, and colleagues presented methods for the phase III MAIN-CAV trial—the first study to systematically address whether adding the multitargeted tyrosine kinase inhibitor cabozantinib to the checkpoint inhibitor avelumab may lead to improved clinical outcomes over avelumab alone in patients with metastatic urothelial cancer. This randomized, multicenter, international trial includes more than 650 adults with locally advanced metastatic urothelial cancer whose disease has not progressed after platinum-based chemotherapy.

From 3 to 10 weeks after the last dose of chemotherapy, patients are randomly assigned 1:1 to receive maintenance avelumb at 800 mg every 2 weeks or a combination of oral avelumb and cabozantinib at 40 mg daily for up to 2 years. Patients will be stratified according to therapeutic response, with overall survival as the primary endpoint and progression-free survival, safety, tolerability, and activity of cabozantinib/avelumb as key secondary endpoints. Quality of life and biomarkers of response and resistance to avelumb will also be assessed. The team plans to use imaging studies to test the correlation of established and new radiomic signatures with overall survival, adverse events, and quality of life.

“There is an unmet need to further improve outcomes by combining [avelumb] with an effective, non–cross-resistant therapy with nonoverlapping toxicity…. We hypothesize that [the cabozantinib/avelumb] combination will be synergistic in patients with metastatic urothelial cancer, with an acceptable safety profile, and will improve upon the benefit seen with [avelumb] maintenance in metastatic urothelial cancer,” the authors commented.

Disclosure: Full authors’ disclosures are available at

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