Study of AM80 Added to Gemcitabine, Cisplatin, and Nivolumab Therapy for Adults with Untreated Unresectable or Recurrent Urothelial Carcinoma

What this Trial Is About

Researchers are studying treatments for urothelial carcinoma, a type of cancer affecting the urinary tract including the bladder, renal pelvis, ureter, and urethra. This trial focuses on patients with unresectable metastatic or recurrent urothelial carcinoma who have not received prior treatment. The goal is to evaluate the effectiveness and safety of a new oral drug called MIKE-1, combined with nivolumab and the chemotherapy drugs gemcitabine and cisplatin, to see if this combination can better reduce or slow down the cancer. Participants receive the investigational drug MIKE-1 also known as AM80 in combination with nivolumab plus gemcitabine and cisplatin, which are given by intravenous infusion. MIKE-1 is a soft capsule taken orally and aims to enhance the effect of the immune checkpoint inhibitor nivolumab by softening the cancer stroma and allowing better drug penetration. After the combination therapy period, patients continue with nivolumab alone. This is an open-label, single-arm trial that explores the added benefit and safety of MIKE-1 alongside the standard chemotherapy and immunotherapy regimen. During the study, participants will undergo regular assessments including CT scans to measure tumor size and response to treatment. Researchers will monitor how much the cancer shrinks or slows down, overall survival, progression-free survival, and duration of response. Safety and side effects will also be closely observed. The study includes eligibility screening, treatment phases, and follow-up evaluations over an extended period. Participants are expected to be followed up for an average of about 49 weeks for survival and progression outcomes.

Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma