Clinical trials: BCG-Unresponsive Bladder Cancer
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
Carcinoma in Situ of Bladder, Bladder Cancer
Phase 2 Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refactory Urothelial Carcinoma in Situ of the Bladder
The purpose of this study is to test if an experimental drug called Durvalumab (Medi4736) given by intravenous (IV) infusion is effective in treating carcinoma in situ (CIS) of the bladder that no longer responds to Bacillus…
- Trial name
- NCT02901548
- Testing
- Durvalumab, Cystoscopy with Biopsy
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
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
1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer
The goal of this part (Part 1) of this clinical research study is to learn about the safety of giving 2 doses of SCH 72105 (also known as rAd-IFN) directly into the bladder to patients with bladder cancer that has come back.
- Trial name
- NCT01162785
- Testing
- SCH 721015
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- M.D. Anderson Cancer Center
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, Non-Muscle Invasive Bladder Cancer (NMIBC)
Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC
The goal of this clinical trial is to learn whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (HG-NMIBC) in adults whose cancer failed conventional…
- Conditions
- Bladder Cancer, Non-Muscle Invasive Bladder Cancer (NMIBC), Urothelial Carcinoma, Carcinoma in Situ (CIS)
- Trial name
- NCT07322263
- Testing
- Intravesical Gemcitabine and Docetaxel
- Where
- United States
- Volunteers
- 174 people
- Sponsor
- Michael A. O'Donnell
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 Cancer
RITE-EUROPE (Radiofrequency-Induced Thermochemotherapy Effect-EUROPE)
This multicenter, prospective, single-arm, phase 3 study will assess the proportion of disease-free patients, starting from administration of the first study treatment to at least 12-months after the first treatment, and up to 2…
- Trial name
- NCT02471495
- Testing
- Synergo® RITE + MMC
- Sponsor
- Medical Enterprises Europe B.V.
Carcinoma in Situ of Bladder
Retrospective Chart Review of Valstar
This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.
- Trial name
- NCT01304173
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Recurrent Bladder Carcinoma, Bladder Cancer Stage 0
sEphB4-HSA in Treating Participants With BCG-Unresponsive or Refractory Bladder Cancer
This phase I trial studies the side effects and best dose of recombinant EphB4-HSA fusion protein (sEphB4-HSA), and to see how well it works in treating participants with bladder cancer that has come back or that isn't responding…
- Conditions
- Recurrent Bladder Carcinoma, Bladder Cancer Stage 0, Bladder Cancer Stage I
- Trial name
- NCT03552796
- Testing
- Pharmacokinetic Study, Recombinant EphB4-HSA Fusion Protein
- Where
- United States
- Sponsor
- University of Southern California
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.
Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy.
- Trial name
- BOND-003 (NCT04452591)
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 86 sites in United States, Australia and 4 more
- Volunteers
- 190 people
- Sponsor
- CG Oncology, Inc.
Non-muscle Invasive Bladder Cancer
A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
The study aims to establish the safety, tolerability, pharmacokinetics (PK), relevant biomarkers, pharmacodynamics (PD) and preliminary anti-tumor activity of the intravesical administration of eciskafusp alfa in combination with…
- Trial name
- NCT06816017
- Testing
- Eciskafusp Alfa, BCG Medac Strain
- Where
- 9 sites in Australia, Italy and 4 more
- Sponsor
- Hoffmann-La Roche
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
Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, Multicentre, Phase 2 Study
Standard treatment for patients with high-risk NMIBC (high-grade Ta, CIS, or any T1) consists of intravesical Bacillus Calmette-Guerin (BCG) immunotherapy.
- Trial name
- BRACE (NCT06990061)
- Testing
- Radiation therapy
- Where
- 3 sites in Belgium
- Volunteers
- 50 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Pharmacokinetics
PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14)
Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) and QUILT-2.005 (CA-ALT-803-01-14)
- Trial name
- NCT04142359
- Testing
- BCG in Combination with N-803, N-803 alone
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Altor BioScience
Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
- Conditions
- Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma, Urologic Cancer, Bladder Cancer
- Trial name
- NCT06443944
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 27 sites in United States
- Sponsor
- CG Oncology, Inc.
Bladder Cancer
RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder
The purpose of this study is to test the safety of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to assess the right doses. Gemcitabine will be given at a fixed dose.
- Trial name
- NCT01259063
- Testing
- Everolimus and Intravesical Gemcitabine
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
- Trial name
- NCT07283835
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 14 sites in China
- Volunteers
- 16 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Bladder Cancer
Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
To evaluate the safety and efficacy of FE 999326 in Japanese subjects with high-grade, BCG unresponsive NMIBC.
- Trial name
- NCT05704244
- Testing
- FE 999326
- Where
- 24 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Ferring Pharmaceuticals