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Urothelial Carcinoma Bladder clinical trials

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

A Phase 3 Single-arm 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: NCT06184516 Not yet recruiting - Clinical trials for Urothelial Carcinoma Bladder

Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy

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

Currently, the standard of care for female patients undergoing radical cystectomy includes the removal of the bladder, pelvic lymph nodes, anterior vagina, uterus, fallopian tubes and ovaries. Removal of female ancillary organs, both in pre and post-menopausal stages is associated with reduction in various quality of life metrics, including sexual health, cognitive decline and depression. Furthermore, removal of ovaries has been associated with increased cardiovascular events, metabolic acidosis, osteoporosis and bone fractures. In premenopausal women, the removal of the ovaries is associated with increased all-cause mortality. From an oncologic standpoint, multi institutional retrospective reviews have demonstrated certain pre-operative radiographic and cystoscopic risk factors that are associated with bladder cancer involvement of female reproductive organs. The absence of these unfavorable risk factors may provide an opportunity to spare women from undergoing unnecessary reproductive organ removal during RC. In doing so, this may eliminate the associated sequelae of removing these additional organs while also providing acceptable oncologic care. The investigators thus propose a decision tool to stratify women undergoing radical cystectomy as favorable and unfavorable for reproductive organ sparing radical cystectomy. This decision tool classification will be used to decide which patients will undergo reproductive organ sparing radical cystectomy versus radical cystectomy in this study.

NCT ID: NCT06090318 Withdrawn - Gastric Cancer Clinical Trials

Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss

Start date: May 19, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, single-arm, Phase 1b/2 study designed to evaluate the safety, tolerability, and preliminary efficacy of milademetan in combination with atezolizumab in patients with advanced solid tumors with confirmed homozygous CDKN2A loss and WT TP53 who have progressed on or are refractory to prior PD-1/PD-L1 inhibitor therapy and who, in the opinion of the Investigator, are unlikely to tolerate or derive clinically meaningful benefit from other therapy. This study will determine the recommended dose of milademetan when given in combination with atezolizumab (the combination RP2D) using a dose de-escalation safety assessment cohort (Phase 1b). Following identification of the combination RP2D, the safety profile and preliminary anti-tumor activity of the combination RP2D will be evaluated in a larger population in a dose expansion cohort (Phase 2).

NCT ID: NCT05839119 Recruiting - Clinical trials for Urothelial Carcinoma Bladder

Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant

TASUC-Neo
Start date: October 2, 2023
Phase: Phase 1
Study type: Interventional

This study is for patients who have bladder cancer that invades into the muscle wall of the bladder. The standard treatment for patients with muscle invasive bladder cancer is to give 4 cycles of chemotherapy with the drugs cisplatin and gemcitabine, then to do an operation to remove the bladder (cystectomy). In this study, the investigators will test participants' bladder cancer to see if their bladder cancer has a receptor for testosterone inside the bladder cancer cells. If it has the testosterone receptor participants will receive a medication called Degarelix that lowers testosterone levels in the blood. Degarelix will be given during the period that participants are receiving the standard of care chemotherapy drugs gemcitabine and cisplatin. The purpose of this study is to evaluate the effects, good and bad, of adding Degarelix to standard chemotherapy for patients with bladder cancer that have the testosterone receptor.

NCT ID: NCT05701332 Not yet recruiting - Clinical trials for Urothelial Carcinoma Bladder

Effect of Intravesical B.C.G and Gemcitabine on Semen Quality and Testicular Volume

Start date: April 1, 2023
Phase: Phase 4
Study type: Interventional

To evaluate the effects of local intravesical B.C.G and gemcitabine on semen quality and testicular volume.

NCT ID: NCT05656235 Not yet recruiting - Bladder Cancer Clinical Trials

Renal Retention in High Grade Upper Tract Urothelial Cancer

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

This trial will evaluate the use of combination pembrolizumab and enfortumab vedotin for patients with high grade non-metastatic (cN0/NxMx, no measurable regional lymph nodes, no metastases) upper tract urothelial cancer (UTUC), preferring to forego standard of care radical nephroureterectomy (RNU) surgery. Currently these patients would not be suitable candidates for neoadjuvant trials, as the patients intention is to forego surgery. The patients are also not candidates for metastatic trials, as the patients have no measurable metastasis. The Investigators hypothesize the combination of pembrolizumab and enfortumab vedotin for patients with high grade cN0/NxMx UTUC deferring RNU will lead to event free survival outcomes similar to that achieved by RNU in a historic dataset.

NCT ID: NCT05401279 Recruiting - Clinical trials for Urothelial Carcinoma Bladder

Bladder Sparing Treatment of Tislelizumab, Gemcitabine and Cisplatin for Patients With PD-L1 Positive Muscle Invasive Bladder Cancer

Start date: June 1, 2022
Phase: Phase 2
Study type: Interventional

This is a phase II open label single-arm prospective study aiming to investigate the efficacy of PD-1 inhibitor Tislelizumab combined with conventional gemcitabine and cisplatin as bladder sparing treatment for patients with PD-L1 positive muscle invasive bladder carcinoma (T2-3N0M0).

NCT ID: NCT05375903 Recruiting - Bladder Cancer Clinical Trials

A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

Start date: June 1, 2022
Phase: Phase 1
Study type: Interventional

This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with recurrent NMIBC.

NCT ID: NCT05312671 Recruiting - Bladder Cancer Clinical Trials

Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer

Start date: June 27, 2022
Phase: Phase 2
Study type: Interventional

This is a single arm, Phase II trial involving the use of atezolizumab plus platinum and etoposide for patients with locally advanced urothelial cancer. The primary goal of this trial is to assess the pathologic complete response rate at cystectomy in patients after being treated with a combination therapy of atezolizumab, platinum, and etoposide.

NCT ID: NCT05243550 Active, not recruiting - Bladder Cancer Clinical Trials

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer

ENVISION
Start date: March 1, 2022
Phase: Phase 3
Study type: Interventional

This Phase 3, multinational, single-arm, multicenter study will evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).