【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.
Patients who have been histologically or cytologically diagnosed with urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra based on the General Rule for Clinical and Pathological Studies on Renal Pelvic, Ureteral and Bladder Cancer, 2nd Edition that cannot be curatively resected or has recurred (diagnosis is not permitted at the site of palliative radiation)
Patients who have not received prior treatment for unresectable or recurrent urothelial carcinoma
Patients with measurable lesions according to RECIST version 1.1 on the CT at screening
Patients with an ECOG PS of 0-1 at screening, who are able to take oral medication
Patients who have previously been treated with drugs such as antibodies targeting PD-1, PD-L1, PD-L2, CTLA-4, OX-40, or CD137
Single group
Add-on effect of adding tamivarotene (AM80) to gemcitabine, cisplatin, and nivolumab combination therapy
DrugTo 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
Response rate (RR)
Response rate (RR): determined by the investigator or sub-investigator at the site. Tumor shrinkage by the best overall response based on the RECIST criteria will be determined by CT scan at each time point. For the same subject, the same imaging method used to evaluate measurable lesions at screening (e.g., the same contrast method) will be used during the study period in principle. The evaluation on each visit day should be performed by the same evaluator as much as possible to ensure internal consistency between each visit day. The response rate is calculated as the ratio of the total number of subjects with complete response (CR) and partial response (PR). CR or PR shall require "confirmation of efficacy".
Overall survival
Overall survival is defined as the period beginning on the date of AM80 administration and ending on the date of death from any cause. For cases that are alive at the cutoff point, the last date of confirmed survival is used as the cutoff date. In the case of untraceable cases, the cutoff date is the last date of confirmed survival before the cutoff.
Progression free survival
Progression" in the evaluation of progression-free survival is defined as Progressive Disease (PD) in the overall efficacy. Progression-free survival is defined as the time to the cut-off point for survivors who have not experienced progression by the time the last patient completes the imaging evaluation at 49 weeks post-treatment (cut-off point). Unfollow-up will be terminated on the date of the last confirmation that there was no progression. For subjects who have started post-treatment without progression, the cut-off date is the date of the last confirmation that there was no progression before the start of post-treatment. However, if nivolumab is continued after completion of study treatment, it will be treated as post-treatment, but will not be censored in the calculation of progression-free survival. If post-treatment other than nivolumab is subsequently started, it will be censored on the last date of confirmation that no progression occurred before that date.
Duration of Response
The duration of response is the period from the start of AM80 administration to the first date of objective confirmation of tumor recurrence or progression of disease from the time of first confirmation of CR or PR in the evaluation of overall efficacy from the start of AM80 administration in cases in which the best overall response was evaluated as CR or PR. The duration of complete response is the period from the start of AM80 administration and the first confirmed CR in the assessment of overall response to the first objectively confirmed date of tumor recurrence. Duration of response and duration of complete response will be evaluated based on the determination by RECIST evaluation, respectively. If no progression of disease is observed at the cut-off time point, the study is terminated on the last date when disease progression is confirmed. For subjects who have started post-treatment without progression, the cut-off date will be the last date of confirmation that there was no p
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Nagoya University
Lead sponsor
Japan Agency for Medical Research and Development
Collaborator
Kyushu University
Collaborator
Chiba University
Collaborator
University of Tsukuba
Collaborator
Kyoto University
Collaborator
