Clinical trials: Non-muscular Invasive Bladder Cancer
Urinary Bladder Neoplasms, Neoplasm Metastasis
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer.
- Conditions
- Urinary Bladder Neoplasms, Neoplasm Metastasis, Ureteral Neoplasms
- Trial name
- FORAGER-1 (NCT05614739)
- Testing
- Vepugratinib, Pembrolizumab, enfortumab vedotin
- Where
- 83 sites in United States, Australia and 12 more
- Volunteers
- 677 people
- Sponsor
- Eli Lilly and Company
Non-muscle Invasive Bladder Cancer
Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1b)
This study is open-label dose expansion study to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor…
- Trial name
- ADVANCED-1 (NCT05085990)
- Testing
- TARA-002
- Where
- 10 sites in United States
- Volunteers
- 10 people
- Sponsor
- Protara Therapeutics
Transitional Cell Carcinoma, Bladder Cancer
Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer
The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the…
- Conditions
- Transitional Cell Carcinoma, Bladder Cancer, Carcinoma in Situ, Carcinoma in Situ Concurrent With Papillary Tumors
- Trial name
- BOND (NCT01438112)
- Testing
- CG0070 Adenovirus Vector, Control Arm: Quadruple Choice
- Where
- 7 sites in United States
- Volunteers
- 22 people
- Sponsor
- CG Oncology, Inc.
Bladder (Urothelial, Transitional Cell) Cancer, Non-Muscle Invasive Bladder Carcinoma
Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer
The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Non-Muscle Invasive Bladder Carcinoma, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
- Trial name
- ADVANCED-3 (NCT07480356)
- Testing
- TARA-002, Investigator's Choice of Intravesical Chemotherapy
- Where
- 11 sites in United States, Ukraine
- Volunteers
- 284 people
- Sponsor
- Protara Therapeutics
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 (NMIBC)
Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer
This is an open-label, phase 2, randomized study of intravesical N-803 plus BCG (experimental arm A) and intravesical N-803 plus gemcitabine (experimental arm B) in participants who have intermediate-risk Ta/T1 papillary disease.
- Trial name
- NCT06829823
- Testing
- N-803 and BCG, N-803 and Gemcitabine
- Volunteers
- 20 people
- Sponsor
- ImmunityBio, Inc.
Bladder Cancer
A Study of Toca 511 & Toca FC in Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer (Toca 8)
This is a Phase 1, multicenter, open-label study of intravesical Toca 511 followed by oral Toca FC in patients with high grade (HG) non-muscle invasive bladder cancer (NMIBC), with cohort expansion at the recommended Phase 2…
- Trial name
- NCT04089163
- Testing
- Toca 511, Toca FC (extended-release formulation of flucytosine)
- Sponsor
- Tocagen Inc.
Bladder Cancer
PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of PF-07225570 alone or in combination with an anti-PD-1 antibody in participants with recurrent…
- Trial name
- NCT05259397
- Testing
- PF-07225570, sasanlimab
- Where
- 4 sites in United States, Poland
- Sponsor
- Pfizer
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.
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, NMIBC
A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
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…
- Conditions
- Non-muscle Invasive Bladder Cancer, NMIBC, Carcinoma in Situ of Bladder, Bladder Cancer
- Trial name
- NCT05375903
- Testing
- UGN-301, UGN-201, Gemcitabine
- Where
- 13 sites in United States, Italy and 1 more
- Volunteers
- 51 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)
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
Bladder Cancer, Non-muscle Invasive Bladder Cancer
Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy
Blue light cystoscopy (BLC) is a diagnostic procedure in bladder cancer where the inside of the bladder is observed with a camera to detect bladder lesions.
- Trial name
- ENAiBLE (NCT07144319)
- Where
- 12 sites in United States, Belgium and 3 more
- Volunteers
- 500 people
- Sponsor
- Photocure
Non-Muscle Invasive Bladder Cancer
Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer
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
- NCT04859751
- Testing
- VB4-845 Injection
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
High-risk Non-muscle-invasive Bladder Cancer
A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy
This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder…
- Trial name
- NCT07468851
- Testing
- HS-10566
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Bladder Cancer
Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group…
- Trial name
- NCT01475266
- Testing
- EO9 (Apaziquone)
- Where
- 20 sites in Japan, South Korea
- Volunteers
- 51 people
- Sponsor
- Nippon Kayaku Co., Ltd.
Bladder Cancer
First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.
- Trial name
- NCT01284205
- Testing
- Mycobacterial Cell-Wall DNA Complex, Bacillus Calmette-Guerin
- Where
- 14 sites in United States
- Sponsor
- Bioniche Life Sciences 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
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.