Clinical trials: High-risk Non-muscle-invasive Bladder Cancer
Bladder Cancer
Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis
Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year.
- Trial name
- NCT03982797
- Testing
- Instillation of IMUNO BCG Moreau RJ
- Where
- 15 sites in Spain
- Volunteers
- 306 people
- Sponsor
- Biofabri, S.L
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 Neoplasms
Phase II Trial of EOquin in High-risk Superficial Bladder Cancer
A non-randomized, open-label phase II study to explore the feasibility, time to recurrence, duration of response and safety of the adjuvant intravesical instillation of EOquin (apaziquone) in patients with high-risk superficial…
- Trial name
- NCT00141531
- Testing
- Apaziquone
- Where
- Netherlands
- Volunteers
- 53 people
- Sponsor
- Spectrum Pharmaceuticals, 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.
Non-muscle-invasive Bladder Cancer
Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)
This is a multi-center study and the aim is to develop and validate an Artificial Intelligence (AI) -based histologic analysis tool to predict responsiveness to intravesical Bacillus Calmette-Guérin (BCG) and intravesical…
- Trial name
- NCT05825950
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- University of Texas Southwestern Medical Center
Non-Muscle Invasive Bladder Cancer, NMIBC
Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC)
The SCORE-NMIBC study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with non-muscle Invasive Bladder Cancer (NMIBC).
- Conditions
- Non-Muscle Invasive Bladder Cancer, NMIBC, High-risk Non-Muscle Invasive Bladder Cancer
- Trial name
- SCORE-NMIBC (NCT07763197)
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Natera, Inc.
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
High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8
IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer
This phase I trial tests the safety and side effects of a PD-L1/IDO peptide vaccine (IO102-IO103) in combination with pembrolizumab in treating patients with non-muscle invasive bladder cancer.
- Conditions
- High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
- Trial name
- NCT05843448
- Testing
- PD-L1/IDO Peptide Vaccine, Pembrolizumab
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of California, Davis
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, High-Risk Cancer
Trial of Local Cystoscopic Injection of Tremelimumab Plus Systemic Durvalumab for High Risk Non-Muscle Invasive Bladder Cancer
We will conduct a Phase I trial testing whether local cystoscopic injection of tremelimumab into the bladder wall in combination with systemic administration of durvalumab in localized bladder cancer will stimulate an effective…
- Conditions
- Bladder Cancer, High-Risk Cancer, Tremelimumab, Durvalumab
- Trial name
- Rideau (NCT05120622)
- Testing
- Tremelimumab
- Where
- Canada
- Sponsor
- University of British Columbia
Bladder Cancer
Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]
The purpose of this study is to find out the effectiveness of pembrolizumab in combination with BCG as a first line therapy for participants with high grade T1 bladder cancer who are at "high risk" for BCG alone to be ineffective…
- Trial name
- NCT03504163
- Testing
- Pembrolizumab (MK-3475), Bacillus Calmette-Guérin (BCG)
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
High-Risk Non-Muscle-Invasive Bladder Cancer
Immunological Response to Intravesical BCG Therapy of Superficial Bladder Cancer by Prior Administration of RUTI®
The RUTIVAC-1 study is a Phase I Clinical Trial designed to evaluate the systemic and mucosal immunological response and provide safety information after the use of RUTI® administration to individuals with NMIBC.
- Trial name
- RUTIVAC-1 (NCT03191578)
- Testing
- RUTI®
- Where
- Spain
- Volunteers
- 44 people
- Sponsor
- Archivel Farma S.L.
High - Risk NMIBC
Observational Clinical Study on High - Risk NMIBC Patients Choosing Trimodality Bladder - Sparing Therapy
The goal of this observational study is to assess the safety and efficacy of trimodality bladder - sparing therapy in high - risk NMIBC patients.
- Trial name
- NCT07053748
- Testing
- Trimodality Bladder-preserving Therapy
- Volunteers
- 30 people
- Sponsor
- Peking University First Hospital
Bladder Cancer
Efficacy of Durvalumab in Non-muscle-invasive Bladder Cancer
Research Hypothesis Approximately 75% of patients with bladder cancer (BC) present with a disease confined to the mucosa (stage Ta, CIS) or submucosa (stage T1) (non-muscle invasive BC [NMIBC]). For high grade NMIBC, i.e.
- Trial name
- NCT03759496
- Testing
- Durvalumab
- Where
- Greece
- Volunteers
- 39 people
- Sponsor
- Hellenic GenitoUrinary Cancer Group
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
Bladder Cancer
Adding Mitomycin to BCG as Adjuvant Intravesical Therapy for High-risk Non-Muscle-invasive Bladder Cancer
Open label, randomised phase 3 trial of the addition of Mitomycin to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer.
- Trial name
- BCG+MM (NCT02948543)
- Testing
- Bacillus of Calmette-Guerin (BCG), Mitomycin (MM)
- Where
- 17 sites in Australia, United Kingdom
- Volunteers
- 501 people
- Sponsor
- University of Sydney
High-risk Non-muscle Invasive Bladder Cancer
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the…
- Trial name
- NCT03711032
- Testing
- Pembrolizumab, BCG
- Where
- 209 sites in United States, Australia and 28 more
- Volunteers
- 1,397 people
- Sponsor
- Merck Sharp & Dohme LLC
Bladder Cancer
Electromotive Mitomycin-C (EMDA-MMC) in Preventing Recurrences in High-risk Non-muscle-invasive Bladder Cancer
Disease recurrence and progression is a major issue in high risk non-muscle-invasive bladder cancer (NMIBC). The current study compares two adjuvant instillation therapies in the treatment of high risk NMIBC.
- Trial name
- FB10 (NCT03664869)
- Testing
- BCG instillation therapy, Sequential BCG and EMDA mitomycin C
- Where
- 7 sites in Finland
- Volunteers
- 300 people
- Sponsor
- Turku University Hospital
NMIBC
ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer
This is an open-label, randomized, phase 3 study of intravesical BCG plus ANKTIVA (experimental arm) versus BCG alone (control arm) in participants who have histologically confirmed, BCG-naïve/BCG-exposed high-grade Ta/T1…
- Trial name
- NCT07551544
- Testing
- BCG (50 mg) plus ANKTIVA (400 µg), BCG (50 mg)
- Sponsor
- ImmunityBio, Inc.
NMIBC
A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.
This prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment…
- Trial name
- NCT06630871
- Testing
- Distitamab Vedotin in combination with Tislelizumab
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Fujian Medical University Union Hospital