RecruitingPhase 2NCT06983210

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

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

Sponsor

Nagoya University

Enrollment

43 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Urothelial Carcinoma Bladder Urothelial Carcinoma of the Renal Pelvis and Ureter Urothelial Carcinoma Urethra Urothelial Carcinoma Recurrent

Summary

【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.

Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called AM80 (tamibarotene, a vitamin A derivative that affects gene expression) combined with standard chemotherapy (gemcitabine and cisplatin) and immunotherapy (nivolumab) in people with advanced or recurrent urothelial carcinoma — a cancer of the bladder, kidney pelvis, ureter, or urethra. **You may be eligible if...** - You are an adult with a confirmed diagnosis of urothelial carcinoma that cannot be surgically removed or has come back - You have not previously received systemic treatment for unresectable or recurrent disease - You have at least one measurable tumor on imaging - You are in good physical condition (ECOG 0-1) and your organ function meets study criteria - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have already received chemotherapy or immunotherapy for advanced urothelial cancer - You have active autoimmune disease or are taking immune-suppressing medications - You have uncontrolled brain metastases or serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdd-on effect of adding tamivarotene (AM80) to gemcitabine, cisplatin, and nivolumab combination therapy

To explore the efficacy and safety of the combination of tamivarotene (AM80), gemcitabine, cisplatin, and nivolumab in the treatment of patients with untreated unresectable or recurrent urothelial cancer