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

Sponsor
Nagoya University
Study ID
NCT06983210
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

【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.

Key Dates

Start date
May 1, 2025
Status verified
Aug 2025
Primary completion
Mar 1, 2027
Completion
Mar 1, 2029

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MIKE-1
    A characteristic pathology of refractory cancers such as advanced urothelial carcinoma is a high proliferation of cancer-associated fibroblasts (CAFs) in the stroma and associated fibrosis. The investigators have previously identified fibroblast-specific meflin as the first functional marker of tumor suppressive CAFs. The investigators hypothesize that increasing the number of mephrin-positive tumor suppressive CAFs may increase the efficacy of ICI. The investigators investigated this in a mouse model of bladder cancer among urothelial carcinomas and confirmed that AM80 administration markedly increased the therapeutic efficacy of ICI. The investigators considered that the efficacy of ICI may be enhanced in patients with urothelial carcinoma when AM80 is administered in combination with ICI. Based on the above, The investigators will explore and evaluate the efficacy and confirm the safety of AM80 when administered in combination with nivolumab, gemcitabine, and cisplatin.

Primary Outcome Measure

Response rate (RR) [ Time Frame: Time from the start of treatment (day 1) to the confirmation of complete response (CR: complete disappearance of tumor) or partial response (PR: reduction of tumor by a certain percentage or more). (Average 18 weeks) ]

Central Contacts

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