Clinical trials: Non-Muscle-Invasive Bladder Cancer (NMIBC), open to volunteers
NMIBC
Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer
Residual tumors after transurethral resection of bladder tumors (TURBT) range from 17-70%, and floating tumor cells from traditional segmental resection may lead to recurrence if they re-implant in the bladder wall.
- Trial name
- HIGCrecur (NCT06889623)
- Testing
- Immediate postoperative chemotherapy
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Changhai Hospital
Non Muscle Invasive Bladder Cancer
A Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing
This study is a prospective, randomized, multicenter clinical trial aiming to enroll 428 patients with non-muscle-invasive bladder cancer (NMIBC) from the Department of Urology at Jiangsu Provincial People's Hospital and its…
- Trial name
- NCT07036731
- Testing
- Urine biomarker -Guided without reTURBT
- Where
- China
- Volunteers
- 428 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
High-risk NMIBC
A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC
The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316.
- Trial name
- NCT05410730
- Testing
- SHR-1501
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Urinary Bladder Neoplasms, Non-muscle Invasive Bladder Cancer (NMIBC)
A Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer
The goal of this clinical trial is to learn if the drug Alpha1H works to treat low-to-intermediate risk non-muscle-invasive bladder cancer in adults. It will also learn about the safety of drug Alpha1H.
- Trial name
- NCT07804056
- Testing
- Alpha1H, Transurethral Resection of Bladder Tumor (TURBT), Intravesical Chemotherapy
- Where
- Czechia
- Volunteers
- 194 people
- Sponsor
- Hamlet Pharma AB
Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8
Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of…
- Conditions
- Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
- Trial name
- GAIN-BCG (NCT07000084)
- Testing
- BCG Solution, Biopsy of Bladder, Cystoscopy
- Where
- 60 sites in United States
- Volunteers
- 330 people
- Sponsor
- Alliance for Clinical Trials in Oncology
HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBT
RC48 in Combination With Radiotherapy for HER2-Expressing NMIBC Patients
This study is an open, single-arm, single-center exploratory clinical study to explore the efficacy and safety of Disitamab Vedotin (RC-48) in combination with radiotherapy for the treatment of patients with HER2-expressing…
- Trial name
- NCT07100184
- Testing
- Disitamab Vedotin combined with Radiotherapy
- Volunteers
- 30 people
- Sponsor
- Peking University First Hospital
Bladder Cancer
Toripalimab Combined With BCG Perfusion for the Treatment of HR-NMIBC After TURBT Surgery Exploration
This is a single-center, prospective, open-label, non-randomized clinical study initiated and conducted by the Department of Urology, Shanghai Changhai Hospital.
- Trial name
- MARINE-01 (NCT07307456)
- Testing
- Treatment with toripalimab combined with BCG perfusion following transurethral resection of bladder tumor (TURBT)
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Changhai Hospital
Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC.
- Conditions
- Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT04752722
- Testing
- EG-70 (phase 1), EG-70 (phase 2) Master Protocol, Surfactant Bladder Pre-Rinse and EG-70 (Substudy)
- Where
- 102 sites in United States, Australia and 8 more
- Volunteers
- 350 people
- Sponsor
- enGene, Inc.
Non-Muscle-Invasive Bladder Cancer (NMIBC)
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy.
- Trial name
- NCT06351904
- Testing
- RAG-01
- Where
- 3 sites in Australia
- Volunteers
- 72 people
- Sponsor
- Ractigen Therapeutics.
Bladder Cancer
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients.
- Trial name
- IMGeS (NCT06388720)
- Testing
- Mitomycin-C, gemcitabine
- Where
- South Korea
- Volunteers
- 82 people
- Sponsor
- National Cancer Center, Korea
Urinary Bladder Neoplasms
A Study to Characterize High-Risk Non-Muscle-Invasive Bladder Cancer Participants in Portugal
The purpose of this study is to understand how the participants with high-risk non-muscle invasive bladder cancer are diagnosed, treated, and cared for in regular clinical practice in Portugal.
- Trial name
- BRITE (NCT07784387)
- Where
- Portugal
- Volunteers
- 250 people
- Sponsor
- Janssen-Cilag Farmaceutica Ltda.
NMIBC
Feasibility of Automatic, Laser-based Distance Control in Persons With Superficial Bladder Tumors
The goal of this clinical investigation is to test the sensing and guiding part of the ATLAS system in the human bladder of people with Ta low grade bladder tumors.
- Trial name
- LUMINA I (NCT07860398)
- Testing
- ATLAS system
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Optheras AS
Bladder Cancer, NMIBC
A Bladder-Sparing Treatment Strategies of Large-Volume Non-Muscle-Invasive Bladder Cancer
Bladder cancer is a common malignancy in the urinary system, ranking 11th in cancer incidence in China (3.48/100,000), with male incidence ranking 8th (5.70/100,000).
- Trial name
- NCT06735287
- Testing
- bladder sparing set, RC
- Where
- China
- Volunteers
- 60 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Intermediate and High-risk Non-muscle Invasive Bladder Cancer
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle…
- Trial name
- NCT06108492
- Testing
- SHR-2005
- Where
- China
- Volunteers
- 170 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Bladder Cancer
DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr
DURANCE is a two part, phase Ib/II, multi-centre study to assess the safety and activity of S-488210/S-488211 in combination with durvalumab, in patients with non-muscle invasive bladder cancer (NMIBC).
- Trial name
- DURANCE (NCT04106115)
- Testing
- Durvalumab, S-488210/S-488211
- Where
- 7 sites in United Kingdom
- Volunteers
- 52 people
- Sponsor
- University College, London
Bladder Cancer
Prognostic Effect of Whether Doing PLND During RC for High-risk NMIBC
There is no consensus on the need for lymph node dissection in radical cystectomy (RC) for high-risk non-muscular invasive bladder cancer (NMIBC).
- Trial name
- PLND-Less (NCT05123625)
- Testing
- Reduce surgical procedures
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Non-muscle Invasive Bladder Cancer (NMIBC)
A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer
The study is to evaluate the safety and tolerability of intravesical FL115 alone or in combination with BCG in the patients with NMIBC, and to determine the RP2D of FL115 in combination with BCG.
- Trial name
- NCT07122414
- Testing
- FL115, FL115+BCG
- Where
- 12 sites in China
- Volunteers
- 80 people
- Sponsor
- Suzhou Forlong Biotechnology Co., Ltd
Non-Muscle-Invasive Bladder Cancer (NMIBC)
Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients
The goal of this clinical trial is to learn if neoadjuvant intravesical instillation of mitomycin C combined with en-bloc surgery works to treat high-risk non-muscle-invasive bladder cancer (NMIBC) patients.
- Trial name
- NCT06696794
- Testing
- Mitomycin C (MMC)
- Where
- 3 sites in China
- Volunteers
- 180 people
- Sponsor
- Shaogang Wang
Papillary-Only Non-muscle-invasive Bladder Cancer
A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC
This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with…
- Trial name
- NiBladder 2 (NCT07726992)
- Testing
- SHR-1501+BCG
- Where
- 2 sites in China
- Volunteers
- 750 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Bladder (Urothelial, Transitional Cell) Cancer, Non Muscle Invasive Bladder Cancer
Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?
Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC) may achieve a tumor-free status after systemic immunotherapy-based bladder-sparing treatment combined with…
- Trial name
- NCT07625527
- Testing
- Active Surveillance, PD-1/PD-L1 Inhibitor-Based Systemic Immunotherapy
- Where
- 4 sites in China
- Volunteers
- 120 people
- Sponsor
- Tianjin Medical University Second Hospital