Actively Recruiting
Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma
Led by Nagoya University · Updated on 2025-08-14
43
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
Sponsors
N
Nagoya University
Lead Sponsor
J
Japan Agency for Medical Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
【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.
CONDITIONS
Official Title
Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra that cannot be cured by surgery or has recurred
- No prior treatment for unresectable or recurrent urothelial carcinoma
- Measurable tumor lesions on CT scan according to RECIST 1.1
- ECOG performance status of 0 or 1 and able to take oral medication
- Expected survival of 12 weeks or more from enrollment
- Adequate organ function including neutrophil count ≥1500/uL, platelet count ≥100,000/uL, hemoglobin ≥9.0 g/dL (no recent red blood cell transfusion), bilirubin ≤1.5 times upper normal limit, AST and ALT ≤3 times upper normal limit, creatinine clearance ≥50 mL/min
- Women of childbearing potential able to use contraception starting 30 days before enrollment and for 2 years after treatment
- Men with partners of childbearing potential who can use contraception until 7 months after treatment ends and avoid sperm donation during this time
- Age between 18 and 79 years
- Provided informed consent after full explanation of the trial
You will not qualify if you...
- Prior treatment with drugs targeting PD-1, PD-L1, PD-L2, CTLA-4, OX-40, or CD137
- Prior perioperative adjuvant therapy completed less than 12 months before enrollment
- Intravesical therapy within 28 days before enrollment
- Palliative radiation therapy for measurable lesions within 14 days before enrollment
- Ongoing toxicity from prior treatments (except mild fatigue or hair loss)
- Participation in other clinical trials within 28 days before enrollment unless similar approved drugs/devices are used
- Brain metastases or history of carcinomatous meningitis
- Multiple cancers with disease-free interval less than 3 years (except certain fully treated cancers)
- Use of vitamin A agents or supplements at enrollment
- Surgery under general anesthesia or severe trauma within 28 days before enrollment
- Bleeding disorders or need for anticoagulants/antiplatelets
- Active infections requiring systemic treatment
- Positive tests for hepatitis B, hepatitis C, or HIV infections
- History or presence of interstitial lung disease or active non-infectious pneumonitis
- Autoimmune disease or recent use of high-dose steroids or immunosuppressants
- Tuberculosis requiring treatment
- Intestinal obstruction or risk factors for intestinal perforation
- Gastrointestinal conditions affecting absorption of the investigational drug
- Severe allergic reactions to study drugs
- Live or attenuated vaccines within 30 days before enrollment
- Serious liver, kidney, heart, lung, blood, or brain diseases
- Uncontrolled adrenal insufficiency or significant hearing or nerve damage
- Hypervitaminosis A
- Lactating women not agreeing to stop breastfeeding
- Pregnant women or positive pregnancy test
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 4668560
Actively Recruiting
Research Team
T
Tomoyasu Sano
CONTACT
Y
Yuri Amano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here