Clinical Trials
Physicians at Columbia Urology are also faculty members at Columbia University Vagelos College of Physicians and Surgeons where they conduct clinical trials on a range of novel and promising treatments for urologic disorders. Our researchers often conduct research collaboratively with each other and with other departments, as part of our comprehensive and integrated research program.
Our clinical studies have already advanced our understanding and treatment of a broad range of urologic disorders. Through clinical trials physicians in our department helped develop the tools and techniques now widely used for robotic prostatectomy and minimally invasive partial nephrectomy, new treatments for kidney cancer, and through our holistic urology program we are testing herbal and naturopathic treatments for a number or urologic problems.
Current Clinical Trials
This is a phase 2, open-label, randomized trial with continuous toxicity monitoring to ensure safety using Bayesian toxicity monitoring, which will evaluate treatment with doublet platinum-based chemotherapy (gemcitabine and cisplatin) plus cemiplimab (REGN2810) with or without fianlimab (REGN3767) for localized muscle-invasive bladder cancer (MIBC). Participants will be randomized to 4 cycles of 3 weeks each (12 weeks total) with gemcitabine, cisplatin, and cemiplimab with or without fianlimab. Participants achieving a clinical complete response will continue 13 more cycles of immunotherapy (39 weeks total). The total duration of systemic treatment, including neoadjuvant therapy, will be 52 weeks.
PI: Christopher B. Anderson, MD
This phase III trial compares the effect of chemotherapy drugs (gemcitabine in combination with docetaxel) to the usual treatment with bacillus Calmette-Guerin (BCG) in patients with non-muscle invasive bladder cancer who have not previously received BCG (BCG naïve). Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. BCG is a weakened form of the bacterium Mycobacterium bovis (bacillus Calmette-Guérin) that does not cause disease. BCG is used in a solution to stimulate the immune system in the treatment of bladder cancer by administering it into the bladder (intravesical). Chemotherapy with intravesical gemcitabine and docetaxel may be similarly effective and not be inferior to the usual treatment with intravesical BCG for shrinking tumor and preventing cancer from coming back (recurrence) in patients with BCG naïve non-muscle invasive bladder cancer.