Urinary Bladder Neoplasms

The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread. Vepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab. Study participation could last up to approximately 6 years.

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer. The study will compare these drugs to concurrent chemoradiotherapy that is usually used to treat this cancer (standard of care). The study will enroll patients with muscle-invasive bladder cancer (MIBC) who have cancer that has not spread outside the bladder.

Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder. The standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding intismeran autogene, the study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study are to learn if people who receive V940 with BCG live longer and without the cancer growing, spreading, or coming back compared to people who receive BCG alone.

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread. Vepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab. Study participation could last up to approximately 6 years.

Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder and has not spread to the bladder muscle or outside of the bladder. In standard treatment for HR NMIBC, doctors first remove the tumor with a procedure called transurethral resection of the bladder tumor (TURBT). Researchers want to learn if using MK-3120, the study medicine, can treat HR NMIBC after TURBT. The goal of this study is to learn about the safety of MK-3120 and if people tolerate it.

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other standard medicines that treat cancer. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.

The Phase IIIb NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with investigator-selected cisplatin-based neoadjuvant chemotherapy (either ddMVAC or gemcitabine/cisplatin) in a clinical practice setting.

The aim of this trial is to investigate the value of FAPI PET/MRI, FDG PET/MRI and MRI in diagnosing MIBC and predicting the efficacy of neoadjuvant therapy for MIBC patients, so as to guide the clinic to adjust the treatment plan in time and benefit MIBC patients.

This is a multicenter, randomized controlled clinical trial (HOPE-07) designed to evaluate the efficacy and safety of perioperative treatment with disitamab vedotin (RC48) combined with toripalimab compared with toripalimab combined with chemotherapy in patients with resectable HER2-expressing (HER2 1+, 2+, or 3+) muscle-invasive bladder cancer (MIBC, cT2-4aN0/1M0).A total of 240 patients will be enrolled and randomized in a 1:1 ratio to receive either RC48 plus toripalimab or chemotherapy plus toripalimab, with 120 patients in each arm. The primary objective is to compare 2-year event-free survival (2-year EFS) between the two treatment groups. Secondary endpoints include pathological complete response (pCR), event-free survival (EFS), disease-free survival (DFS), 1-year event-free survival (1-year EFS), metastasis-free survival (MFS), overall survival (OS), R0 resection rate, and safety outcomes including adverse events (AEs), serious adverse events (SAEs), vital signs, physical examination, ECOG performance status, laboratory tests, and electrocardiography, assessed according to CTCAE v5.0. Exploratory objectives include assessment of quality of life using EQ-5D-5L and EORTC QLQ-C30, evaluation of associations between biomarkers (HER2 expression, PD-L1 expression, circulating tumor DNA) and treatment efficacy, and multi-omics analyses using tumor tissue, ctDNA, and urinary tumor DNA to identify potential predictive biomarkers.

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors. The study will have four parts. * Part A of the study will find out how much sigvotatug vedotin should be given to participants. * Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors. * Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs. * Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors. * In Parts C and D, participants will receive sigvotatug vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin.

This is an adaptive, open-label, randomised phase II trial that aims to evaluate the impact of 3 vs 6 cycles of first-line platinum-based chemotherapy followed by maintenance avelumab in the quality of life of patients with locally advanced or metastatic urothelial cancer. Initially, 224 eligible and evaluable patients (112 in each arm) will receive 3 cycles vs 6 cycles of 3-weekly gemcitabine plus cisplatin/carboplatin, followed by 2-weekly maintenance avelumab until disease progression or intolerable toxicities. Avelumab treatment will be given up to a maximum of 2 years from the end of chemotherapy.

This is a Phase II, prospective, single-arm, open-label clinical study evaluating hyperthermic intravesical chemotherapy (HIVEC) with Mitomycin C in patients with high-grade, non-muscle-invasive bladder cancer (NMIBC) who are BCG-non-responsive or BCG-intolerant and are ineligible for, or refuse, radical cystectomy. Mitomycin C is an approved medicinal product used within routine clinical practice and administered with a CE-marked recirculation device (BRS Combat system) that maintains the solution at approximately 43°C for 60 minutes. The treatment schedule consists of 6 weekly induction instillations followed by 9 monthly maintenance instillations. The co-primary objectives are to describe the safety and toxicity profile of HIVEC, including treatment discontinuations due to procedure-related toxicity, and to estimate the 12-month recurrence-free survival (12moRFS). Secondary objectives include characterizing patterns of non-muscle-invasive and muscle-invasive recurrences, bladder cancer-specific survival, overall survival, and quality of life. Approximately 50 patients will be enrolled in this single-center pilot study to generate exploratory safety and efficacy data in this high-risk population and to support the design of future randomized trials

This study evaluates our team's urology-specific AI (UroMed AI Doctor) for its safety, professionalism, knowledge and Q\&A ability, and tests its effectiveness against traditional manual urology care, to confirm if it can be a safe auxiliary tool and improve patients' preoperative experience. Before the study, we will test the AI with urology questions, compare it to international AI models (DeepSeek, ChatGPT, Google Gemini), and have two senior chief physicians evaluate it. In the clinical trial, patients at The First Affiliated Hospital of Guangxi Medical University will be randomly split into two groups: AI-assisted care or traditional care by a specialist. Two senior specialists will evaluate both groups blindly; each group will get preoperative education (AI or physician), with anxiety and satisfaction surveyed. Subsequently, a multi-center validation will be conducted with 11 domestic and international hospitals.

Bladder cancer is a significant global health issue. When the cancer spreads into the muscle layer of the bladder (muscle-invasive bladder cancer), a common treatment is the surgical removal of the bladder (radical cystectomy). However, even after surgery, it can be difficult for doctors to accurately predict how an individual patient's disease will progress using standard staging methods. This retrospective observational study aims to find better ways to predict patient outcomes by examining the tumor microenvironment, which is the environment immediately surrounding the cancer cells. Specifically, researchers are looking at the relationship between the tumor cells, the surrounding supportive tissue (the stroma), and the patient's natural immune cells. The study will review existing medical records and archived tumor tissue samples from at least 100 patients who underwent radical cystectomy at the South Egypt Cancer Institute between 2018 and 2024. Under a microscope, researchers will assess three main features: * Tumor-Stroma Ratio (TSR): The amount of tumor tissue compared to the surrounding supportive tissue. * Tumor-Infiltrating Lymphocytes (TILs): The number of immune cells that have moved into the tumor to try and fight it. * Tertiary Lymphoid Structures (TLS): Organized clusters of immune cells that form near the tumor. By analyzing these features, the researchers hope to determine if specific patterns of immune and supportive cells are linked to better or worse survival rates, such as Overall Survival and Disease-Free Survival. Understanding this immune-stromal landscape could lead to more personalized risk assessments and better treatment plans for future bladder cancer patients.

Intravesical Bacillus Calmette-Guérin (BCG) therapy is the standard adjuvant treatment for patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC). However, BCG therapy frequently induces local bladder irritation symptoms including urinary frequency, urgency, dysuria, hematuria, and suprapubic pain, which may reduce quality of life and lead to treatment interruption. Blad-Care™ is an intravesical therapy containing hyaluronic acid and chondroitin sulfate, key components of the urothelial glycosaminoglycan (GAG) layer. Restoration of the GAG layer may protect the bladder mucosa and reduce inflammation-induced bladder irritation symptoms. This prospective randomized study aims to determine whether early administration of intravesical Blad-Care during BCG induction improves BCG-induced bladder toxicity compared with delayed administration after completion of BCG induction therapy.

Lymphedema of the extremities is common after lymph node surgery in treating several forms of cancer, e.g., breast cancer. However, very little is known of the occurrence of lymphedema of the lower extremities after urologic surgery with lymph node dissection. This project aims to describe the frequency and grade of lymphedema arising after urologic surgery, using the Lymphedema Quality of Life Questionnaire (LymQOL), Delfin MoistureMeter D, and lower limb volume measurements.

This is a phase Ib study of the safety and performance of a novel intravesical contrast-enhanced Magnetic Resonance Imaging protocol for determination of bladder cancer stage prior to transurethral resection of bladder tumor (21 subjects) or prior to radical cystectomy for muscle invasive disease (21 subjects). Subjects will undergo a single MRI study: a pre-contrast, single breath hold image followed by sterile placement of a temporary urethral catheter for instillation of a 50mL solution containing Gadobutrol (4 mM) plus ferumoxytol (5 mM) and then a second, post-contrast image. Images will be reviewed by two dedicated abdominal radiologists, who are blinded to the pathologic staging, for determination of tumor presence and depth of bladder wall penetration.

This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or BCG-intolerant high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Two prespecified cohorts are analysed: (1) CIS cohort (CIS with/without Ta/T1) and (2) non-CIS cohort (high-risk Ta/T1 without CIS). In the combination arm, intravesical GEM→MMC is given weekly for 6 weeks (induction) and, for patients without recurrence at the first tumour assessment (\~month 3), monthly maintenance continues up to 24 months or until progression/unacceptable toxicity; toripalimab IV every 3 weeks starts during the first intravesical cycle and continues up to 24 months or until progression/unacceptable toxicity. The monotherapy arm receives toripalimab IV every 3 weeks up to 24 months or until progression/unacceptable toxicity. Cystoscopy and urine cytology are performed every 3 months; imaging every 24 weeks. Primary endpoints are 3-month complete response (CR) rate in the CIS cohort and median recurrence-free survival (RFS) in the non-CIS cohort. Secondary endpoints include landmark CR, PFS and OS, RFS/HG-RFS landmarks in the non-CIS cohort, and safety (CTCAE v5.0). Exploratory analyses will assess outcomes by protocol-defined PD-L1 status. Approximately 106 participants will be enrolled at multiple sites in China.

This randomized, double-blind, placebo-controlled, multicenter trial evaluates the efficacy and safety of Antarctic krill oil in reducing side effects of intravesical therapy for non-muscle-invasive bladder cancer (NMIBC). A total of 210 participants (18-75 years) will be randomized to receive either 2g/day of krill oil capsules (containing phospholipids, DHA, EPA, and astaxanthin) or placebo during intravesical treatment (epirubicin, pirarubicin, or BCG). Primary outcomes include bladder irritation symptoms (IPSS score), systemic adverse events, hematuria, and urinary tract infections. Secondary outcomes assess quality of life (QoL). Safety will monitor adverse events per CTCAE v5.0. The study follows GCP standards and includes rigorous data management and ethical oversight. Results may offer a dietary intervention to improve treatment tolerance and QoL for bladder cancer patients.

The purpose of this trial is to evaluate a new drug, HTL0039732, that will be administered on its own (as a monotherapy) and in combination with atezolizumab or with other approved anti-cancer therapies, in participants with advanced solid tumours.

Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer. However, research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective. Currently, ongoing clinical trials have not discussed the effectiveness of PD-1/PD-L1 inhibitors combined with BCG instillation in reducing postoperative recurrence in intermediate-risk NMIBC. Therefore, this study aims to explore the clinical efficacy and safety of tislelizumab combined with BCG in the treatment of intermediate and high-risk NMIBC. For this purpose, investigators have established strict screening criteria to include eligible patients in the study and have recruited suitable patients from multiple medical centers.Investigators have also developed a meticulous implementation process and follow-up considerations, hoping to better verify the clinical efficacy and safety of the combined use of these two drugs.

The goal of the Flemish Databank for Urothelial Cancer is to collect clinical and pathological data of patients treated for urothelial cancer (UC).

To compare the urinary continence rate and long-term oncological outcomes of pelvic-organ preserving radical cystectomy (POPRC) with orthotopic ileal neobladder (OIN) versus standard radical cystectomy(SRC) with OIN.