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New treatment option for Urothelial Carcinoma Bladder
Official title Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma
ClinicalTrials.gov ID: NCT06983210
What this study is testing
What is Add-on effect of adding tamivarotene (AM80) to gemcitabine, cisplatin, and nivolumab combination therapy?
Add-on effect of adding tamivarotene (AM80) to gemcitabine, cisplatin, and nivolumab combination therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for urothelial carcinoma bladder.
Also referred to as AM80.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 【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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- Patients who have been histologically or cytologically diagnosed with urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra based on...
- 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 will be expected to survive for 12 weeks or more from the enrollment
You likely can't join if
- Patients who have previously been treated with drugs such as antibodies targeting PD-1, PD-L1, PD-L2, CTLA-4, OX-40, or CD137
- Patients who have received any of the following t reatments for urothelial carcinoma: (1)Perioperative adjuvant therapy for curative resection...
See the full eligibility criteria
- 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...
- 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 will be expected to survive for 12 weeks or more from the enrollment
- Patients whose 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...
- Female patients of childbearing potential who can prevent contraception for 30 days prior to enrollment and for 2 years after the end of AM80 treatment
- Male patients with partners of childbearing potential, who can use contraception from the start of AM80 administration until 7 months after the end of administration and refrain from donating sperm during the above...
- Patients who have previously been treated with drugs such as antibodies targeting PD-1, PD-L1, PD-L2, CTLA-4, OX-40, or CD137
- Patients who have received any of the following t reatments for urothelial carcinoma: (1)Perioperative adjuvant therapy for curative resection completed less than 12 months prior to enrollment (2)Intravesical therapy...
The study team makes the final eligibility decision.
Where it's taking place
- Nagoya, Aichi-ken, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nagoya, Aichi-ken, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.