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Carcinoma, Transitional Cell clinical trials

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NCT ID: NCT06439836 Not yet recruiting - Clinical trials for Metastatic Urothelial Carcinoma

Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy

Start date: August 30, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety, side effects, best dose, and effectiveness of emavusertib (CA-4948) in combination with pembrolizumab in treating patients with urothelial cancer that has spread from where it first started to other places in the body (metastatic) and that has a resistance to PD-1/PD-L1 immune checkpoint inhibitors. CA-4948, a kinase inhibitor, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving CA-4948 in combination with pembrolizumab may be safe, tolerable and/or effective in treating patients with metastatic urothelial cancer that is resistant to PD-1/PD-L1 immune checkpoint inhibitors.

NCT ID: NCT06427993 Not yet recruiting - Bladder Cancer Clinical Trials

Urine DNA Methylation Detection for Hematuria Evaluation

Start date: June 15, 2024
Phase:
Study type: Observational

Background: Hematuria, a common symptom of urinary system diseases, can result from various causes including infection, stones, trauma, and tumors. Urothelial carcinoma (UC), the most common malignancy of the urinary system, often presents with hematuria. Current diagnostic methods like urine cytology and cystoscopy have limitations in sensitivity and specificity, and cystoscopy is invasive. DNA methylation biomarkers offer potential for non-invasive UC detection, improving diagnostic accuracy in hematuria patients. Objective: This study aims to evaluate the diagnostic performance of DNA methylation biomarkers in detecting UC in patients with hematuria. Methods: This prospective pilot study will involve collecting preoperative urine samples from hematuria patients for DNA methylation testing using MSRE-qPCR. Sample size calculation was based on an assumed 25% prevalence of UC in hematuria patients, resulting in a total of 71 participants after accounting for a 20% dropout rate. Sensitivity, specificity, and diagnostic performance will be assessed using ROC curves. Conclusion: This study seeks to validate the effectiveness of urine DNA methylation testing for UC detection in hematuria patients, providing a basis for its clinical application and informing the design of larger future studies.

NCT ID: NCT06424717 Not yet recruiting - Clinical trials for Urothelial Carcinoma

Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L)1 Therapy (JAVELIN DDRiver Bladder)

Start date: July 29, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the antitumor activity of avelumab in combination with tuvusertib in terms of objective response in participants with advanced urothelial carcinoma. Study details include: Condition/Disease: Participants with urothelial carcinoma (locally advanced and unresectable, or metastatic) that has progressed on prior anti-PD-(L)1 therapy Treatment Duration: Participants will be treated until progressive disease, death, or discontinuation due to e.g. withdrawal of consent or lost to follow-up Visit Frequency: While receiving study intervention, participants will visit the site twice per every 21-day study intervention period. 1 week after end of study intervention, participants will visit the site for an End of Study Intervention Visit, followed by 2 Safety Follow-Up visits at 1 and 3 months after last dose, and thereafter have remote Long-Term Follow-up every 3 months. Study Duration: The overall study is planned to close after the last participant has been followed up for at least 12 months.

NCT ID: NCT06421311 Not yet recruiting - Clinical trials for Urothelial Carcinoma

Observational Study of Muscle Invasive Urothelial Carcinoma Participants Treated With Adjuvant Nivolumab in France

URADJ
Start date: June 15, 2024
Phase:
Study type: Observational

This study will estimate the real-world effectiveness of adjuvant nivolumab therapy in adult participants with muscle invasive urothelial carcinoma (MIUC) in France.

NCT ID: NCT06405425 Not yet recruiting - Clinical trials for Urothelial Carcinoma

A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Start date: May 2024
Phase: Phase 2
Study type: Interventional

This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 combination therapy in patients with locally advanced or metastatic urothelial carcinoma.

NCT ID: NCT06396533 Not yet recruiting - Clinical trials for Urothelial Carcinoma

Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)

INSITE
Start date: May 2024
Phase:
Study type: Observational

This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy. Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.

NCT ID: NCT06364904 Not yet recruiting - Bladder Cancer Clinical Trials

An Phase III Study, Multicenter,Randomized Controlled Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.

Start date: April 15, 2024
Phase: Phase 3
Study type: Interventional

The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy.

NCT ID: NCT06356155 Not yet recruiting - Clinical trials for Urothelial Carcinoma

Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer

NEPTUNE
Start date: October 2024
Phase: Phase 2
Study type: Interventional

This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in cisplatin-eligible patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab.

NCT ID: NCT06331299 Not yet recruiting - Bladder Cancer Clinical Trials

A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer

UTOPIA
Start date: July 2024
Phase: Phase 3
Study type: Interventional

This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).

NCT ID: NCT06318871 Not yet recruiting - Clinical trials for Renal Cell Carcinoma

Memory-like Natural Killer (NK) Cell Therapy With N-803 in Patients With Renal Cell Carcinoma or Urothelial Carcinoma

Start date: June 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this research study is to establish the safety and then to explore the effectiveness of infusing the combination of cytokine-induced memory-like (CIML) natural killer (NK) cells, a type of immune cell in the blood that is collected and bathed in special proteins to help identify and treat curtained advanced cancers, combined with N-803, a medication that increases the activity of Interleukin-15, which is a cytokine that activates immune cells, in advanced clear cell renal cell carcinoma and urothelial carcinoma. Names of the study therapies involved in this study are/is: - CIML NK cell therapy (a NK cell therapy) - N-803 (a type of recombinant human IL-15 superagonist)