Clinical trials: BCG-Unresponsive Bladder Cancer
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
Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
This is a single-arm, multicenter study to evaluate the efficacy and safety of HX008 injection in patients with BCG-unresponsive non-muscle invasive bladder cancer.
- Trial name
- NCT04738630
- Testing
- HX008
- Where
- 5 sites in China
- Volunteers
- 110 people
- Sponsor
- Taizhou Hanzhong biomedical co. LTD
Recurrent Bladder Urothelial Carcinoma, Stage 0a Bladder Urothelial Carcinoma AJCC v6 and v7
Atezolizumab in Treating Patients With Recurrent BCG-Unresponsive Non-muscle Invasive Bladder Cancer
This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back (recurrent) and has not responded to treatment (refractory) with Bacillus Calmette-Guerin…
- Conditions
- Recurrent Bladder Urothelial Carcinoma, Stage 0a Bladder Urothelial Carcinoma AJCC v6 and v7, Stage 0is Bladder Urothelial Carcinoma AJCC v6 and v7, Stage I Bladder Urothelial Carcinoma AJCC v6 and v7
- Trial name
- NCT02844816
- Testing
- Atezolizumab
- Where
- 272 sites in United States, Canada
- Volunteers
- 172 people
- Sponsor
- National Cancer Institute (NCI)
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.
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.
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive/-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study
This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or…
- Conditions
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Carcinoma in Situ of Bladder, Non-Muscle-Invasive Bladder Cancer
- Trial name
- OHAI-NMIBC-01 (NCT07189793)
- Testing
- Toripalimab, Gemcitabine (GEM), Mitomycin C (MMC)
- Where
- China
- Volunteers
- 106 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
Bladder Cancer
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients.
- Trial name
- IMGeS (NCT06388720)
- Testing
- Mitomycin-C, gemcitabine
- Where
- South Korea
- Volunteers
- 82 people
- Sponsor
- National Cancer Center, Korea
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
Non Muscle Invasive Bladder Cancer
Intravesical Chemotherapy in Combination With Systemic Pembrolizumab in NMIBC Unresponsive or Exposed to BCG Therapy
interventional study of intravesical chemotherapy and sistemic immunotherapy in NMIBC
- Trial name
- NCT06972615
- Testing
- intravesical Chemotherapy docetaxel/gemcitabine
- Where
- Argentina
- Volunteers
- 37 people
- Sponsor
- BLATAM
Bladder Cancer
Rogaratinib for BCG Refractory High Risk Non-Muscle Invasive Bladder Cancer With FGFR1/2 Overexpression
This research study is studying the safety, tolerability, and tumor activity of the study drug known as rogaratinib as a possible treatment for bladder cancer.
- Trial name
- NCT04040725
- Testing
- Rogaratinib
- Sponsor
- Dana-Farber Cancer Institute
Urothelial Carcinoma, Bladder Cancer
Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder
Upon successful screening and registration, enrollment to a cohort will begin. If DLT criteria are exceeded in a cohort, that cohort will close and will not proceed to Phase 2 of the study.
- Trial name
- ADAPT-BLADDER (NCT03317158)
- Testing
- Durvalumab (Cohort 1-3), External Beam Radiotherapy (EBRT), Bacillus Calmette-Guérin (BCG)
- Where
- 9 sites in United States
- Volunteers
- 186 people
- Sponsor
- Noah Hahn, M.D.
Bladder Cancer
Dovitinib in BCG Refractory Urothelial Carcinoma With FGFR3 Mutations or Over-expression
This trial will assess the 6-month complete response rate and toxicity profile of oral dovitinib therapy in BCG-refractory urothelial carcinoma patients with tumors with FGFR3 mutations or over-expression who are ineligible for…
- Trial name
- NCT01732107
- Testing
- Dovitinib
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Noah Hahn, M.D.
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
Bladder Carcinoma in Situ (CIS)
Study of ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID)
Phase I exploratory, open-label, single arm, multicenter study to assess safety, tolerability and antitumor activity of ONCOFID-P-B™ therapy in adult patients with histologically confirmed diagnosis of bladder carcinoma in situ…
- Trial name
- NCT04798703
- Testing
- ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID)
- Where
- 5 sites in Italy, Spain
- Volunteers
- 20 people
- Sponsor
- Fidia Farmaceutici s.p.a.
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
Bladder Cancer
QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus N-803 or N-803 only in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC).
- Trial name
- NCT03022825
- Testing
- N-803 and BCG, N-803
- Where
- 28 sites in United States
- Volunteers
- 190 people
- Sponsor
- ImmunityBio, 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
DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr
DURANCE is a two part, phase Ib/II, multi-centre study to assess the safety and activity of S-488210/S-488211 in combination with durvalumab, in patients with non-muscle invasive bladder cancer (NMIBC).
- Trial name
- DURANCE (NCT04106115)
- Testing
- Durvalumab, S-488210/S-488211
- Where
- 7 sites in United Kingdom
- Volunteers
- 52 people
- Sponsor
- University College, London
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
Urothelial Carcinoma of the Urinary Bladder
Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment Urothelial Carcinoma of the Bladder
The investigators intend to evaluate the safety and toxicity profile of intravesically administered multidrug regimen of Cabazitaxel, Cisplatin and Gemcitabine in treatment refractory Transitional Cell Carcinoma.The investigators…
- Trial name
- CGC (NCT02202772)
- Testing
- Cabazitaxel, Gemcitabine, Cisplatin
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Guarionex J. Decastro