Clinical trials: Invasive Bladder Cancer
Bladder Cancer
Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine
A Multicenter, Non-randomized, Uncontrolled, Open-label Phase I/II study to Observe the Safety and Preliminary Efficacy of Catumaxomab in Patients with Non-Muscle-Invasive Bladder Cancer who have Failed or are Intolerant to…
- Trial name
- NCT04799847
- Testing
- Catumaxomab
- Where
- 5 sites in China
- Volunteers
- 161 people
- Sponsor
- LintonPharm Co.,Ltd.
Bladder Cancer, Bladder Tumor
A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk…
- Conditions
- Bladder Cancer, Bladder Tumor, Muscle-Invasive Bladder Cancer
- Trial name
- NCT04209114
- Testing
- Nivolumab, Radical cystectomy (RC), Bempegaldesleukin
- Where
- 116 sites in United States, Argentina and 18 more
- Volunteers
- 114 people
- Sponsor
- Bristol-Myers Squibb
Non Muscle Invasive Bladder Cancer, Bladder Cancer
Hyperthermic Intravesical Chemotherapy (HIVEC) in BCG-Non-Responsive High-Grade NMIBC Patients
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…
- Conditions
- Non Muscle Invasive Bladder Cancer, Bladder Cancer, Carcinoma in Situ of Bladder, Urinary Bladder Neoplasms
- Trial name
- HIVEC (NCT07231809)
- Testing
- Hyperthermic Intravesical Chemotherapy (HIVEC)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- AC.TA. S.r.l.
Carcinoma of Urinary Bladder, Superficial
Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBC
In the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent NMIBC lesions and to compare…
- Trial name
- OPTIMA (NCT01803295)
- Testing
- 40 mg MMC gel, Standard of care MMC mixed with water, 80 mg MMC gel
- Where
- 13 sites in Israel, Italy and 2 more
- Volunteers
- 80 people
- Sponsor
- UroGen Pharma Ltd.
Non-muscle Invasive Bladder Cancer
CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)
The study consisted of 2 sequential parts. Part A assessed the safety and tolerability of CAVATAK administered via intravesical instillation in patients with non-muscle invasive bladder cancer scheduled to undergo TUR.
- Trial name
- CANON (NCT02316171)
- Testing
- CVA21, Mitomycin C
- Where
- United Kingdom
- Volunteers
- 16 people
- Sponsor
- Viralytics
Bladder Cancer
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current…
- Trial name
- KEYNOTE-B15 (NCT04700124)
- Testing
- Pembrolizumab, Enfortumab vedotin (EV), RC + PLND
- Where
- 188 sites in United States, Argentina and 27 more
- Volunteers
- 808 people
- Sponsor
- Merck Sharp & Dohme LLC
Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer
A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT
This is a Phase 3, open-label, randomized trial designed to evaluate the DFS of TURBT followed by NDV-1 (sustained-release gemcitabine-docetaxel) versus TURBT followed by surveillance for the treatment of participants with…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer, Urothelial Carcinoma Bladder, Urologic Cancer
- Trial name
- BOOST (NCT07313891)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Sponsor
- Relmada Therapeutics, Inc.
Bladder Cancer, Bladder Cancer Recurrent
Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)
The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE…
- Conditions
- Bladder Cancer, Bladder Cancer Recurrent, Neoplasm Recurrence, Urothelial Carcinoma Bladder
- Trial name
- EVER (NCT05037279)
- Testing
- Bacillus Calmette-Guerin: Strain Russian BCG-I, Bacillus Calmette-Guerin: Strain TICE
- Where
- 6 sites in Canada
- Volunteers
- 540 people
- Sponsor
- Verity Pharmaceuticals Inc.
Non Muscle Invasive Bladder Cancer
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have…
- Trial name
- CORE-001 (NCT04387461)
- Testing
- CG0070, Pembrolizumab Injection, n-dodecyl-B-D-maltoside
- Where
- 19 sites in United States, South Korea
- Volunteers
- 35 people
- Sponsor
- CG Oncology, Inc.
Bladder Cancer, Urothelial Carcinoma
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Renal Pelvis Carcinoma
- Trial name
- ATLAS (NCT03397394)
- Testing
- Rucaparib
- Where
- 64 sites in United States, France and 4 more
- Volunteers
- 97 people
- Sponsor
- pharmaand GmbH
Bladder (Urothelial, Transitional Cell) Cancer, NMIBC
A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC
This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, NMIBC, Urothelial Carcinoma Bladder, Urothelial Carcinoma in Situ
- Trial name
- NCT07725796
- Testing
- UGN-501
- Where
- 15 sites in United States
- Volunteers
- 30 people
- Sponsor
- UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.
Non-Muscle Invasive Bladder Neoplasms
A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States
The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free…
- Trial name
- Nova-sTAR (NCT07309445)
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Janssen Research & Development, LLC
Bladder Cancer
Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
This is a single-arm, multicenter study to evaluate the efficacy and safety of HX008 injection in patients with BCG-unresponsive non-muscle invasive bladder cancer.
- Trial name
- NCT04738630
- Testing
- HX008
- Where
- 5 sites in China
- Volunteers
- 110 people
- Sponsor
- Taizhou Hanzhong biomedical co. LTD
Urinary Bladder Cancer
Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between diagnosis and radical cystectomy (RC).
- Trial name
- NCT02722538
- Testing
- Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200
- Where
- 6 sites in United States, Netherlands
- Volunteers
- 23 people
- Sponsor
- Taris Biomedical LLC
Bladder Cancer
Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)
This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL…
- Trial name
- NCT01469221
- Testing
- Apaziquone
- Where
- 29 sites in United States, Czechia and 2 more
- Volunteers
- 47 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG
Intravesical Photodynamic Therapy (PDT) in BCG Refractory High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
This is a phase Ib, open-label, single-arm, single-center study conducted in Canada. Subjects with NMIBC (Ta, T1, and/or Tis) who are not candidates for or have refused radical cystectomy will be eligible for participation in the…
- Trial name
- NCT03053635
- Testing
- TLD1433 infusion and photodynamic therapy (PDT) treatment
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- Theralase® Technologies Inc.
Non-Muscle-Invasive Bladder Cancer (NMIBC)
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC
This is an open-label, multicenter phase 1 study to evaluate the safety, efficacy, and pharmacokinetics (PK) characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin (BCG) in participants with…
- Trial name
- NCT06186414
- Testing
- SIM0237, SIM0237 and BCG
- Where
- 14 sites in China
- Volunteers
- 152 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Bladder Cancer, Urothelial Carcinoma
Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC)
This study aims to demonstrate that home instillation of UGN-102 is a feasible alternative to instillation in a clinical setting, which might mitigate patient challenges (logistical, expense, and comfort) when receiving treatment…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- NCT05136898
- Testing
- UGN-102
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- UroGen Pharma Ltd.
Urinary Bladder Neoplasms
A Study of Stimulator of Interferon Genes (STING) Agonist E7766 in Non-muscle Invasive Bladder Cancer (NMIBC) Including Participants Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy, INPUT-102
This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intravesically in participants with NMIBC.
- Trial name
- NCT04109092
- Testing
- E7766
- Where
- 9 sites in United States
- Sponsor
- Eisai Inc.
Various Advanced Cancer
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
- Trial name
- CheckMate 274 (NCT02632409)
- Testing
- Nivolumab
- Where
- 188 sites in United States, Argentina and 28 more
- Volunteers
- 709 people
- Sponsor
- Bristol-Myers Squibb