Clinical trials: Non-Invasive Bladder Urothelial Carcinoma
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
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.
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
Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG
Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected papillary…
- Trial name
- NCT03945162
- Testing
- Ruvidar® (TLD-1433) bladder infusion and PDT
- Where
- 16 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Theralase® Technologies Inc.
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.
Urothelial Cancer, Urinary Bladder Neoplasms
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer.
- Trial name
- NCT07566156
- Testing
- Enfortumab vedotin, Conventional Radiotherapy, Hypofractionated Radiotherapy
- Where
- 26 sites in United States, Canada and 2 more
- Volunteers
- 390 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Carcinoma, Transitional Cell, Bladder Neoplasms
Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
- Trial name
- NCT00109655
- Testing
- Oncolytic adenovirus (serotype 5) - CG0070
- Where
- 10 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Cell Genesys
Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
- Trial name
- RESCUE (NCT07342517)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Relmada Therapeutics, Inc.
Urinary Bladder Neoplasms, Urologic Neoplasms
SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I
A multi-institutional, prospective, randomised, open-label, superiority, comparative, active-controlled, phase 3 study. The study will compare Synergo RF-induced hyperthermia-chemotherapy (SHTC) plus mitomycin C (MMC) to standard…
- Conditions
- Urinary Bladder Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms
- Trial name
- SHTC-EUROPE-1 (NCT02254915)
- Testing
- Synergo + MMC, Bacillus Calmette-Guérin
- Sponsor
- Medical Enterprises Europe B.V.
Non Muscle Invasive Bladder Cancer
Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.
- Trial name
- NCT02982395
- Testing
- Nanoxel®M, Mitomycin-C
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Samyang Biopharmaceuticals Corporation
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.
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- ATLAS (NCT04688931)
- Testing
- UGN-102, TURBT
- Where
- 139 sites in United States, Bulgaria and 8 more
- Volunteers
- 282 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
Clear Cell Renal Cell Cancer (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC)
A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors
The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of [68Ga]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC)…
- Conditions
- Clear Cell Renal Cell Cancer (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer (CRC), Urothelial Carcinoma (UC)
- Trial name
- NCT05706129
- Testing
- [68Ga]Ga-DPI-4452, [177Lu]Lu-DPI-4452
- Where
- 10 sites in Australia, France
- Volunteers
- 270 people
- Sponsor
- Lumara Bio Oncologics GmbH
Urothelial Carcinoma, Non Muscle Invasive Bladder Cancer
Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER
A national, multicenter, non-randomized, retrospective, observational study (Real-World Evidence-RWE) aimed at analyzing clinical presentation profiles and demographic characteristics of patients with early urothelial bladder…
- Conditions
- Urothelial Carcinoma, Non Muscle Invasive Bladder Cancer, Muscle-invasive Bladder Cancer
- Trial name
- NCT05945108
- Where
- 5 sites in Brazil
- Volunteers
- 400 people
- Sponsor
- AstraZeneca
Urinary Bladder Neoplasms
Phase I Study of Inactivated UPEC-FimON for Non Muscle Invasive Bladder Cancer After BCG or Intravesical Chemotherapy Failure
This is a Phase I, open-label, multicenter, dose-escalation study that aims to evaluate the safety and tolerability of intravesical inactivated Instillations of UPEC-FimON (Uro-Pathogenic E.
- Trial name
- NCT07881666
- Testing
- Inactivated UPEC-FimON
- Where
- 3 sites in Israel
- Volunteers
- 30 people
- Sponsor
- Hopec Pharma
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 Neoplasms
Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer
The purpose of this study is to determine the efficacy and safety of intravesical Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional cell carcinoma (papillary tumors and/or carcinoma in…
- Trial name
- NCT00406068
- Testing
- Mycobacterial cell wall-DNA complex
- Where
- 31 sites in United States, Canada
- Volunteers
- 129 people
- Sponsor
- Bioniche Life Sciences Inc.
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.
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.