Multi-center, Open-Label, Single Arm Trial for Evaluation of the Efficacy and Safety in the First Line Combination Therapy of Gemcitabine, Cisplatin and Nivolumab With Additional Pretreatment of AM80 for Urothelial Carcinoma Patients
【Treatment of Urothelial Carcinoma】 Treatment for urothelial carcinoma includes surgery, chemotherapy (anticancer drugs), and radiation therapy. Chemotherapy is generally used when metastasis has already occurred at diagnosis and surgery is not curative (metastatic urothelial carcinoma) or when the cancer recurs after local therapy such as surgery or radiation therapy (recurrent urothelial carcinoma). Although there are several recommended treatments for urothelial carcinoma, the options are often limited by side effects and other factors, and these treatments may not be fully effective. Therefore, the development of safer and more effective treatments is desired. 【About the Drugs to be Used in this Clinical Trial】 In this clinical trial, the investigational drug MIKE-1 will be used in combination with nivolumab plus GC (cisplatin gemcitabine), one of the recommended chemotherapy regimens, and subsequently with nivolumab monotherapy for patients with unresectable metastatic or recurrent urothelial cancer. Nivolumab, cisplatin, and gemcitabine are injectable (intravenous infusion), while MIKE-1 is oral. 【Purpose of the Clinical Trial】 The purpose of this clinical trial is to evaluate the efficacy (how much the cancer shrinks or slows down) and safety of the investigational drug MIKE-1 in combination with nivolumab and gemcitabine and cisplatin therapy in patients with untreated unresectable or recurrent urothelial cancer.
• Patients who have been histologically or cytologically diagnosed with urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra based on the General Rule for Clinical and Pathological Studies on Renal Pelvic, Ureteral and Bladder Cancer, 2nd Edition that cannot be curatively resected or has recurred (diagnosis is not permitted at the site of palliative radiation)
• Patients who have not received prior treatment for unresectable or recurrent urothelial carcinoma
• Patients with measurable lesions according to RECIST version 1.1 on the CT at screening
• Patients with an ECOG PS of 0-1 at screening, who are able to take oral medication
• Patients who will be expected to survive for 12 weeks or more from the enrollment
• Patients whose major organ functions at screening meet the following criteria
⁃ (1)Neutrophil count: 1,500/uL or more (2)Platelet count: 100,000/uL or more (3)Hb: 9.0 g/dL or more (no red blood cell transfusion within 14 days prior to screening examination) (4)T-Bil: 1.5 times or less than 1.5 times the upper limit of the facility standard value (less than 3.0 mg/dL in the case of Gilbert syndrome) (5)AST and ALT: 3 times or less than 3 times the upper limit of the facility standard value (6)CrCl 50 mL/min or more 7.Patients who have given consent to be treated if any of the following applies:
• Female patients of childbearing potential who can prevent contraception for 30 days prior to enrollment and for 2 years after the end of AM80 treatment
• Male patients with partners of childbearing potential, who can use contraception from the start of AM80 administration until 7 months after the end of administration and refrain from donating sperm during the above period 8.Patients aged 18-79 years at the time of consent (regardless of sex) 9.Patients who have received a thorough explanation of this clinical trial and have voluntarily given their written informed consent