Clinical Trial TitleMAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum-Based Chemotherapy in Patients with Metastatic Urothelial Cancer
National Clinical Trial Number:NCT05092958
Clinical Trial Protocol Description:
This phase III trial compares the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and avelumab together may further shrink the cancer or prevent it from returning/progressing.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a diagnosis of advanced or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra.
- Have had prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy (platinum-based chemotherapy; gemcitabine-cisplatin, gemcitabine-carboplatin, methotrexate, vinblastine, doxorubicin and cisplatin [MVAC] or dose-dense [dd]MVAC).
- Have had no more than 1 line of prior chemotherapy for metastatic or locally advanced disease (neoadjuvant or adjuvant chemotherapy will be allowed if given 12 or more months prior to registration).
You will be excluded from the study if any of the following criteria apply to you:
- Have active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
- Have no known symptomatic central nervous system (CNS) metastases.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
See clinicaltrials.gov for a comprehensive list of inclusion/exclusion criteria.