Clinical trials: Muscle-invasive Bladder Cancer, open to volunteers
Non-muscle Invasive Bladder Cancer
Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
The purpose of this study is to test the safety of the study drug 2141-V11 in people whose NMIBC did not respond to standard treatment, and who will not have the standard surgical procedure to remove the bladder.
- Trial name
- NCT05126472
- Testing
- anti-CD40 antibody 2141-V11, Intravesical Gemcitabine, Intravesical Gemcitabine with anti-CD40 antibody 2141-V11
- Where
- 7 sites in United States
- Volunteers
- 115 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Non-Muscle-Invasive Bladder Cancer (NMIBC)
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC
This is an open-label, multicenter phase 1 study to evaluate the safety, efficacy, and pharmacokinetics (PK) characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin (BCG) in participants with…
- Trial name
- NCT06186414
- Testing
- SIM0237, SIM0237 and BCG
- Where
- 14 sites in China
- Volunteers
- 152 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Urology
Efficacy and Safety of Two Bladder-preserving Treatment Durations With Disitamab Vedotin Plus Toripalimab Combination in Her2-expressing Muscle-invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial
This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS…
- Trial name
- NCT07151560
- Testing
- 6 cycle RC48 and JS001, 12 cycle RC48 and JS001
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Renmin Hospital of Wuhan University
Bladder Cancer, Non Muscle Invasive
Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer
The purpose of this study is to determine the safety and tolerability of intravesical BH011 in patients with high-risk non-muscle invasive bladder cancer（NMIBC） after Bacillus Calmette-Guerin（BCG） failure and to assess the…
- Trial name
- NCT06732531
- Testing
- BH011
- Where
- 6 sites in China
- Volunteers
- 48 people
- Sponsor
- Zhuhai Beihai Biotech Co., Ltd
NMIBC, Non-Muscle Invasive Bladder Urothelial Carcinoma
A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.
This study is being conducted to establish a novel tumor tissue- and blood-based biomarker test to assess early systemic and local response to immunomodulation by BCG immunotherapy in patients with high-risk non-muscle invasive…
- Conditions
- NMIBC, Non-Muscle Invasive Bladder Urothelial Carcinoma, Bladder (Urothelial, Transitional Cell) Cancer, Urothelial Carcinoma Bladder
- Trial name
- BCG-TIME (NCT07064863)
- Testing
- Gemcitabine + BCG, BCG (TICE strain)
- Where
- Canada
- Volunteers
- 31 people
- Sponsor
- Queen's University
Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months.
- Trial name
- ABLE-22 (NCT06545955)
- Testing
- Nadofaragene Firadenovec, Gemcitabine, Docetaxel
- Where
- 81 sites in United States, Canada and 6 more
- Volunteers
- 250 people
- Sponsor
- Ferring Pharmaceuticals
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
High-Risk Non-Muscle-Invasive Bladder Cancer
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.
- Trial name
- NCT06567743
- Testing
- Cretostimogene Grenadenorepvec
- Where
- 80 sites in United States, Canada
- Volunteers
- 325 people
- Sponsor
- CG Oncology, Inc.
Muscle Invasive Bladder Urothelial Carcinoma
Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or…
- Trial name
- NCT06809140
- Testing
- Enfortumab vedotin, Pembrolizumab
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- Matthew Galsky
Bladder Cancer, Urothelial Carcinoma
Risk-Enabled Therapy After Initiating EV/Pembro for Bladder Cancer
RETAIN-3 is a phase II study in patients with cT2-T3N0M0 muscle-invasive urothelial carcinoma of the bladder. Participants will receive neoadjuvant enfortumab vedotin and pembrolizumab followed by clinical and biomarker-based…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Muscle-Invasive Bladder Carcinoma, Muscle-invasive Bladder Urothelial Carcinoma
- Trial name
- RETAIN-3 (NCT07908979)
- Testing
- Enfortumab vedotin, Pembrolizumab, Cisplatin
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Fox Chase Cancer Center
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Researchers are looking for new ways to treat people with 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…
- Conditions
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Carcinoma in Situ
- Trial name
- NCT06833073
- Testing
- Intismeran autogene, BCG
- Where
- 89 sites in United States, Argentina and 17 more
- Volunteers
- 308 people
- Sponsor
- Merck Sharp & Dohme LLC
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
NMIBC
Trop2-Targeted Near-Infrared Fluorescence Imaging-Guided Precise Resection of Non-Muscle Invasive Bladder Cancer
Research Objective Taking Trop2, a specific target of bladder urothelial carcinoma, as the research basis, this study adopts a Trop2-targeted near-infrared (NIR) fluorescent probe combined with an intravesical rapid incubation…
- Trial name
- NCT07800507
- Testing
- TTP-ICG NIR fluorescent diagnostic agent
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Yunnan Cancer Hospital
Muscle-Invasive Bladder Carcinoma, Gastroesophageal Adenocarcinoma
Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease
This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease.
- Conditions
- Muscle-Invasive Bladder Carcinoma, Gastroesophageal Adenocarcinoma, Melanoma, Non-small Cell Lung Cancer
- Trial name
- NCT06529822
- Testing
- Synthetic long peptide personalized cancer vaccine, Poly ICLC, Signatera or Altera testing
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Washington University School of Medicine
Muscle-invasive Bladder Cancer
Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express Fibroblast Growth Factor Receptor (FGFR…
- Trial name
- SOGUG-NEOWIN (NCT06511648)
- Testing
- Erdafitinib monotherapy, Cetrelimab and Erdafitinib combination
- Where
- 23 sites in France, Italy and 2 more
- Volunteers
- 90 people
- Sponsor
- Spanish Oncology Genito-Urinary Group
Muscle-invasive Bladder Cancer
Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics
Although neoadjuvant chemotherapy in muscle-invasive bladder cancer has significantly improved oncological outcomes, approximately 50% of patients do not respond to neoadjuvant chemotherapy, which has adverse effects on patients…
- Trial name
- NCT06373055
- Testing
- neoadjuvant chemotherapy followed by radical cystectomy
- Where
- South Korea
- Volunteers
- 250 people
- Sponsor
- Yonsei University
Muscle Invasive Bladder Cancer
Pilot Study on Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) as Neoadjuvant Therapy for Platinum-refractory Muscle-invasive Bladder Cancer
This trial aims to evaluate the efficacy, safety, and biological mechanisms of rutin combined with tislelizumab and GC(Gemcitabine and Cisplatin) in platinum-refractory muscle-invasive bladder cancer patients.
- Trial name
- NCT06916494
- Testing
- Rutin, Gemcitabine, Cisplatin, Tislelizumab
- Where
- China
- Volunteers
- 10 people
- Sponsor
- First Affiliated Hospital of Chongqing Medical University
Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer
Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer
This is a prospective, multicenter, randomized controlled superiority study designed to evaluate whether the addition of pelvic lymph node dissection improves bladder-intact event-free survival in patients with cT2-3N0M0 bladder…
- Conditions
- Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer, Bladder Cancer
- Trial name
- NCT07756008
- Testing
- Disitamab Vedotin (RC48), Toripalimab, Transurethral Resection of Bladder Tumor
- Where
- China
- Volunteers
- 114 people
- Sponsor
- Tianjin Medical University Second Hospital
Non-Muscle Invasive Bladder Cancer
A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
This is a phase II randomized controlled clinical trial comparing standard induction BCG versus bicalutamide and standard induction BCG among patients with non-muscle invasive bladder cancer.
- Trial name
- BicaBCa (NCT05327647)
- Testing
- Bicalutamide, Control Arm
- Where
- 7 sites in Canada
- Volunteers
- 160 people
- Sponsor
- CHU de Quebec-Universite Laval
Bladder Cancer, Muscle-Invasive Bladder Carcinoma
RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients
A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of…
- Trial name
- NCT06341400
- Testing
- DisitamabVedotinForIicction Toripalimab
- Where
- China
- Volunteers
- 55 people
- Sponsor
- Zhujiang Hospital