OncoMatch/Clinical Trials/NCT06983210
Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma
Is NCT06983210 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Add-on effect of adding tamivarotene (AM80) to gemcitabine, cisplatin, and nivolumab combination therapy for urothelial carcinoma bladder.
Treatment: Add-on effect of adding tamivarotene (AM80) to gemcitabine, cisplatin, and nivolumab combination therapy — 【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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
previously been treated with drugs such as antibodies targeting PD-1
Cannot have received: anti-PD-L1 therapy
previously been treated with drugs such as antibodies targeting PD-L1
Cannot have received: anti-PD-L2 therapy
previously been treated with drugs such as antibodies targeting PD-L2
Cannot have received: anti-CTLA-4 therapy
previously been treated with drugs such as antibodies targeting CTLA-4
Cannot have received:
previously been treated with drugs such as antibodies targeting OX-40
Cannot have received:
previously been treated with drugs such as antibodies targeting CD137
Cannot have received: perioperative adjuvant therapy
Exception: completed less than 12 months prior to enrollment
Perioperative adjuvant therapy for curative resection completed less than 12 months prior to enrollment
Cannot have received: intravesical therapy
Exception: within 28 days prior to enrollment
Intravesical therapy within 28 days prior to enrollment
Cannot have received: palliative radiation therapy
Exception: for measurable lesions within 14 days prior to enrollment
Palliative radiation therapy for measurable lesions within 14 days prior to enrollment
Lab requirements
Blood counts
Neutrophil count: 1,500/uL or more; Platelet count: 100,000/uL or more; Hb: 9.0 g/dL or more (no red blood cell transfusion within 14 days prior to screening examination)
Kidney function
CrCl 50 mL/min or more
Liver function
T-Bil: ≤1.5x ULN (less than 3.0 mg/dL in the case of Gilbert syndrome); AST and ALT: ≤3x ULN
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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