Clinical trials: Non-Muscle Invasive Bladder Cancer (NMIBC)
Urinary Bladder Neoplasms, Carcinoma in Situ
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC).
- Conditions
- Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT05014139
- Testing
- Enfortumab vedotin
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 37 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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.
Nonmuscle-invasive Bladder Cancer
A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
This is a Phase II clinical study to evaluate the efficacy and safety of intravesical T3011 injection in participants with BCG-unresponsive high-risk NMIBC or BCG-exposed, chemotherapy-unresponsive intermediate/high-risk NMIBC.
- Trial name
- NCT06971614
- Testing
- T3011
- Where
- 9 sites in United States
- Volunteers
- 160 people
- Sponsor
- ImmVira Pharma Co. Ltd
Non-Muscle Invasive Bladder Cancer (NMIBC)
Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment
A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG.
- Trial name
- NMIBC (NCT03672240)
- Testing
- APL-1202
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Asieris Pharmaceutical Technologies Co., Ltd.
NMIBC
ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
This is a phase 1/2, open-label, multicenter study of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) in participants with Non-muscle invasive bladder cancer (NMIBC) who have not received Bacillus…
- Trial name
- NCT06800963
- Testing
- Intravesical Recombinant Mycobacterium (rMBCG)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- ImmunityBio, Inc.
Non-muscle Invasive Bladder Cancer
Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients
To evaluate the clinical efficacy (median event-free survival) of APL-1202 in combination with Epirubicin hydrochloride versus Epirubicin hydrochloride alone in intermediate and high-risk chemo-refractory non-muscle invasive…
- Trial name
- ACCRUE (NCT04490993)
- Testing
- APL-1202 in combination with Epirubicin
- Where
- China
- Volunteers
- 359 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
NMIBC
A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with…
- Trial name
- NCT07424287
- Testing
- SHR-1501 for Injection, BCG for Injection, Epirubicin Hydrochloride for Injection
- Where
- 2 sites in China
- Volunteers
- 236 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Bladder Cancer
Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC).
- Trial name
- NCT01373398
- Testing
- EO9(Apaziquone)
- Where
- 2 sites in South Korea
- Volunteers
- 11 people
- Sponsor
- Handok Inc.
Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
Study REL-NDV01-303 is a Phase 3, open-label, multi-center study to determine the safety and efficacy of NDV-01 in adult participants with NMIBC.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
- Trial name
- RESCUE (NCT07464145)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Volunteers
- 393 people
- Sponsor
- Relmada Therapeutics, Inc.
Non-muscle Invasive Bladder Cancer
A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients
A multi-center, randomized, open-label, parallel-controlled Phase Ⅲ clinical trial to evaluate the clinical safety and efficacy of APL-1202 as a single-agent oral treatment versus intravesical instillation of Epirubicin…
- Trial name
- ASCERTAIN (NCT04736394)
- Testing
- APL-1202, Epirubicin Hydrochloride
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
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.
Non-Muscle- Invasive Bladder Cancer
BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants
The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed…
- Trial name
- PATAPSCO (NCT05943106)
- Testing
- Durvalumab, BCG
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
NMIBC
RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in…
- Trial name
- NCT05943379
- Testing
- RC48-ADC in Combination with gemcitabine
- Where
- China
- Volunteers
- 85 people
- Sponsor
- RemeGen Co., Ltd.
Bladder Cancer
Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure
To study the safety and efficacy of CG0070, an oncolytic virus expression GM-CSF in high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.
- Trial name
- BOND2 (NCT02365818)
- Testing
- CG0070
- Where
- 17 sites in United States
- Volunteers
- 66 people
- Sponsor
- CG Oncology, Inc.
Non-muscle Invasive Bladder Cancer
A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer.
- Trial name
- CREST (NCT04165317)
- Testing
- PF-06801591, Bacillus Calmette-Guerin
- Where
- 196 sites in United States, Australia and 12 more
- Volunteers
- 1,068 people
- Sponsor
- Pfizer
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 Cancer (NMIBC)
LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder
This study is a phase IIA, single-site, randomized, controlled, open-label clinical trial evaluating the safety and efficacy of the LCS103 oral herbal formula for the secondary prevention of NMIBC.
- Trial name
- LCS103 (NCT07728474)
- Testing
- LCS103
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- LifeBiotic Medical Research Ltd.
Urinary Bladder Neoplasms, Urologic Neoplasms
Pilot Study to Evaluate the Clinical Response to Mitomycin-C in Hydrogel (TC-3) Administered Intravesically in NMIBC Patients
The purpose of this study is to evaluate the clinical response of the tumors within the bladder of recurrent NMIBC patients to Mitomycin-C embedded in UroGen Pharma's (known at that time as TheraCoat Ltd.) TC-3 Sterile Hydrogel…
- Conditions
- Urinary Bladder Neoplasms, Urologic Neoplasms, Neoplasms, Urinary Bladder Diseases
- Trial name
- NCT02891460
- Testing
- 40 mg MMC in 40 mL TC-3., 80 mg MMC in 40 mL TC-3.
- Where
- India
- Volunteers
- 18 people
- Sponsor
- UroGen Pharma Ltd.
Bladder Cancer, CIS
A Prospective Registry to Assess the Effectiveness and Local Tolerability of Intravesical Valrubicin in Subjects With Non-muscle Invasive Bladder Cancer (NMIBC)
The purpose of this study is to observe and describe the effectiveness and local tolerability of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a cohort of subjects treated under routine…
- Trial name
- NCT01314664
- Where
- 11 sites in United States
- Volunteers
- 15 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Non Muscle Invasive Bladder Cancer, Urologic Cancer
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.
- Conditions
- Non Muscle Invasive Bladder Cancer, Urologic Cancer, Bladder Cancer, Urothelial Carcinoma
- Trial name
- NCT06111235
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 95 sites in United States, Canada
- Volunteers
- 367 people
- Sponsor
- CG Oncology, Inc.