Clinical trials: Non-muscle-invasive Bladder Cancer
- Condition Non-muscle-invasive Bladder Cancer
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Bladder Neoplasms
Instillation of Gemcitabine in Patients With Superficial Bladder Cancer
A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor.
- Trial name
- NCT00191477
- Testing
- Gemcitabine
- Where
- Germany
- Volunteers
- 355 people
- Sponsor
- Eli Lilly and Company
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.
Carcinoma in Situ, Transitional Cell Carcinoma
Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder
This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with valrubicin following induction with valrubicin…
- Conditions
- Carcinoma in Situ, Transitional Cell Carcinoma, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT01310803
- Testing
- VALSTAR - Maintenance Therapy, No Maintenance treatment ( Standard of Care)
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
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
Superficial Bladder Cancer
ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC.
- Trial name
- NCT02773849
- Testing
- ADSTILADRIN
- Where
- 34 sites in United States
- Volunteers
- 157 people
- Sponsor
- Ferring Pharmaceuticals
Bladder Cancer
Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer
The purpose of this study is to explore a treatment that potentially enhances the delivery of chemotherapy to tumors in participants with superficial bladder cancer.
- Trial name
- NCT00318643
- Testing
- Mitomycin C, Chemophase
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Halozyme Therapeutics
Superficial Bladder Cancer
Intravesical Administration of rAd-IFN/Syn3 in Patients With BCG-Refractory or Relapsed Bladder Cancer
This Phase 2 study is designed to assess the efficacy and safety of INSTILADRIN (rAd-IFN with Syn3) when given intravesically to patients with high grade non-muscle invasive bladder cancer who are refractory to or have relapsed…
- Trial name
- NCT01687244
- Testing
- INSTILADRIN
- Volunteers
- 40 people
- Sponsor
- FKD Therapies Oy
Bladder Cancer
A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting
The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope…
- Trial name
- NCT02560584
- Testing
- Hexaminolevulinate hydrochloride, KARL STORZ D-Light C PDD Flexible Videoscope System
- Where
- 17 sites in United States
- Volunteers
- 304 people
- Sponsor
- Photocure
Bladder Cancer
Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer
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
- NCT01410565
- Testing
- Apaziquone
- Where
- 47 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Bladder Neoplasm, Neoplasm Recurrence, Local
Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide.
- Conditions
- Bladder Neoplasm, Neoplasm Recurrence, Local, Transitional Cell, Carcinoma, Carcinoma in Situ
- Trial name
- EMBARC-RF (NCT01200992)
- Testing
- EN3348, Mitomycin C
- Where
- 72 sites in United States, Canada and 4 more
- Volunteers
- 84 people
- Sponsor
- Bioniche Life Sciences Inc.
Bladder Cancer, Urothelial Carcinoma
Evaluation of NanoDoce® in Participants With Urothelial Carcinoma
This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation.
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm, Urinary Bladder Cancer
- Trial name
- NCT03636256
- Testing
- NanoDoce (direct injection), NanoDoce (intravesical instillation) - Visit 2 Instillation, Institutional Standard of Care
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- NanOlogy, LLC
Bladder Cancer, Urothelial Carcinoma
A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer
This Phase 2b, single-arm, multicenter study evaluated 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).
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- OPTIMA II (NCT03558503)
- Testing
- UGN-102
- Where
- 19 sites in United States, Israel
- Volunteers
- 63 people
- Sponsor
- UroGen Pharma Ltd.
Bladder Cancer
A Study of Intravesical Apaziquone as a Surgical Adjuvant in Participant Undergoing Transurethral Resection Bladder Tumor (TURBT)
This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder cancer (NMIBC), ≤3.5 centimeters (cm) in diameter, all of which must…
- Trial name
- NCT02563561
- Testing
- Apaziquone
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Non-muscle Invasive Bladder Cancer (NMIBC)
Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC
This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose…
- Trial name
- NCT03719300
- Testing
- inodiftagene vixteplasmid
- Where
- 48 sites in United States
- Volunteers
- 32 people
- Sponsor
- Anchiano Therapeutics Israel Ltd.
Urinary Bladder Neoplasms
A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor…
- Trial name
- NCT04172675
- Testing
- Erdafitinib, Investigator Choice (Gemcitabine), Investigator Choice (Mitomycin C)
- Where
- 150 sites in United States, Argentina and 15 more
- Volunteers
- 107 people
- Sponsor
- Janssen Research & Development, LLC
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
This Phase 3, single-arm, multicenter study was designed to evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with recurrent low-grade intermediate-risk…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- UTOPIA (NCT06331299)
- Testing
- UGN-103
- Where
- 48 sites in United States, Bulgaria and 5 more
- Volunteers
- 99 people
- Sponsor
- UroGen Pharma Ltd.
Bladder Cancer
A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT
Phase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose…
- Trial name
- NCT02010203
- Testing
- HS-410, BCG
- Where
- 19 sites in United States
- Volunteers
- 104 people
- Sponsor
- Heat Biologics
Bladder Cancer
A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)
This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in participants with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC), assessed according to the 2016 American…
- Trial name
- NCT03224182
- Testing
- Qapzola
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Urinary Bladder Neoplasms
A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder
A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.
- Trial name
- CheckMate 9UT (NCT03519256)
- Testing
- Nivolumab, BCG, BMS-986205
- Where
- 88 sites in United States, Argentina and 13 more
- Volunteers
- 142 people
- Sponsor
- Bristol-Myers Squibb
Bladder Cancer
Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy.
- Trial name
- VISTA (NCT02449239)
- Testing
- Vicinium
- Where
- 70 sites in United States, Canada
- Volunteers
- 133 people
- Sponsor
- Sesen Bio, Inc.