Synthetic retinoid-mediated preconditioning of cancer-associated fibroblasts and macrophages improves cancer response to immune checkpoint blockade.
Takayuki Owaki, Tadashi Iida, Yuki Miyai...
https://pubmed.ncbi.nlm.nih.gov/38849479Actively Recruiting
Phase 2
Age: 18Years - 79Years
All Genders
ID06983210
Multi-center, Open-Label, Single Arm Trial Evaluating the Efficacy and Safety of Gemcitabine, Cisplatin, Nivolumab, and AM80 (MIKE-1) Combination Therapy in Patients With Urothelial Carcinoma
Led by Nagoya University · Updated on 2025-08-14
43
Participants Needed
1
Research Sites
104 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
Researchers are studying treatments for urothelial carcinoma, a type of cancer affecting the urinary tract including the bladder, renal pelvis, ureter, and urethra. This trial focuses on patients with unresectable metastatic or recurrent urothelial carcinoma who have not received prior treatment. The goal is to evaluate the effectiveness and safety of a new oral drug called MIKE-1, combined with nivolumab and the chemotherapy drugs gemcitabine and cisplatin, to see if this combination can better reduce or slow down the cancer. Participants receive the investigational drug MIKE-1 (also known as AM80) in combination with nivolumab plus gemcitabine and cisplatin, which are given by intravenous infusion. MIKE-1 is a soft capsule taken orally and aims to enhance the effect of the immune checkpoint inhibitor nivolumab by softening the cancer stroma and allowing better drug penetration. After the combination therapy period, patients continue with nivolumab alone. This is an open-label, single-arm trial that explores the added benefit and safety of MIKE-1 alongside the standard chemotherapy and immunotherapy regimen. During the study, participants will undergo regular assessments including CT scans to measure tumor size and response to treatment. Researchers will monitor how much the cancer shrinks or slows down, overall survival, progression-free survival, and duration of response. Safety and side effects will also be closely observed. The study includes eligibility screening, treatment phases, and follow-up evaluations over an extended period. Participants are expected to be followed up for an average of about 49 weeks for survival and progression outcomes.
CONDITIONS
Brief Title
Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma
Who Can Participate
Age: 18Years - 79Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra that cannot be completely removed 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 to 1 and able to take oral medication
- Expected to survive at least 12 weeks from enrollment
- Adequate major organ function as defined by specific blood counts and liver and kidney function
- Female patients of childbearing potential able to use contraception from 30 days before enrollment until 2 years after treatment
- Male patients with partners of childbearing potential able to use contraception from treatment start until 7 months after treatment
- Age between 18 and 79 years
- Provided informed consent after being fully explained the trial
You will not qualify if you...
- Previous treatment with drugs targeting PD-1, PD-L1, PD-L2, CTLA-4, OX-40, or CD137
- Prior perioperative adjuvant therapy within 12 months or intravesical therapy within 28 days before enrollment
- Palliative radiation therapy for measurable lesions within 14 days before enrollment
- Unresolved toxicity from prior treatments except mild fatigue or alopecia
- Participation in other clinical trials within 28 days unless similar drug/device and indication
- Metastasis to central nervous system or history of carcinomatous meningitis
- Multiple cancers with less than 3 years disease-free interval (with some exceptions)
- Current use of vitamin A agents or supplements
- Recent surgery or severe trauma within 28 days
- Bleeding disorders or need for anticoagulants/antiplatelets
- Active infections requiring systemic treatment
- Positive tests for hepatitis B, C, or HIV with some exceptions
- History or presence of interstitial lung disease or active pneumonitis
- Autoimmune disease or recent use of high-dose steroids or immunosuppressants
- Need for tuberculosis treatment
- Intestinal obstruction or risk of intestinal perforation
- Gastrointestinal disorders affecting absorption of MIKE-1
- Severe allergies to study drugs
- Recent live or attenuated vaccinations
- Serious complications in major organs
- Uncontrolled adrenal insufficiency or significant hearing/neuropathy impairment
- Hypervitaminosis A
- Lactating or pregnant females or positive pregnancy test
- Any other condition deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 18 weeks until initial tumor response assessment
Participants receive a combination therapy including the investigational drug MIKE-1 (AM80) taken orally, along with intravenous infusions of gemcitabine, cisplatin, and nivolumab to treat unresectable or recurrent urothelial carcinoma.
Regular visits for treatment administration and monitoring during the combination therapy period
Follow-up
Duration - Up to 49 weeks on average
Participants are monitored for overall survival, progression-free survival, and duration of response after treatment completion.
Periodic visits for ongoing monitoring and safety assessments
Trial Site Locations
Total: 1 location
1
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 4668560
Actively Recruiting
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Research Team
T
Tomoyasu Sano
Y
Yuri Amano
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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