This is a non-blinded phase 2 trial in Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab to assess whether bladder preservation after dual immunotherapy would be a viable treatment option for patients responding to treatment
Willing and able to provide informed consent
Age ≥ 18 years
Resectable muscle-invasive UC of the bladder, defined as cT2-4aN0M0 OR cT1-4aN1M0. In cT1N1 patients, lymph node positivity would need to be cytologically or histologically confirmed.
Surgical resection (cystectomy) is the advised locoregional treatment and is accepted by the subject after consultation with the urologist.
Subjects with active autoimmune disease in the past 2 years. Patients with diabetes mellitus, properly controlled hypothyroidism or hyperthyroidism, vitiligo, psoriasis or other mild skin disease can still be included.
Documented history of severe autoimmune disease (e.g. inflammatory bowel disease, myasthenia gravis).
Previous intravenous systemic therapy or radiotherapy for UC.
Upper urinary tract disease, unless all disease is planned to be resected in the same surgery as for UBC. This includes non-muscle-invasive disease.
The Netherlands Cancer Institute
Lead sponsor
Bristol-Myers Squibb
Collaborator