Clinical trials: Muscle Invasive Bladder Cancer
Non-Muscle Invasive Bladder Neoplasms
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin…
- Trial name
- SunRISe-5 (NCT06211764)
- Testing
- TAR-200, Mitomycin C, Gemcitabine
- Where
- 123 sites in United States, Argentina and 12 more
- Volunteers
- 272 people
- Sponsor
- Janssen Research & Development, LLC
Non-Muscle Invasive Bladder Neoplasms
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.
- Trial name
- MoonRISe-1 (NCT06319820)
- Testing
- TAR-210, Gemcitabine, MMC
- Where
- 193 sites in United States, Argentina and 18 more
- Volunteers
- 641 people
- Sponsor
- Janssen Research & Development, LLC
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
- 80 sites in United States, Canada and 6 more
- Volunteers
- 250 people
- Sponsor
- Ferring Pharmaceuticals
Non-Muscle Invasive Bladder Neoplasms
Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use
The purpose of this pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC).
- Trial name
- NCT06877676
- Testing
- TAR-200
- Sponsor
- Janssen Research & Development, LLC
Non-Muscle Invasive Bladder Neoplasms
A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States
The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free…
- Trial name
- Nova-sTAR (NCT07309445)
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Janssen Research & Development, LLC
Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer
Pan-tumor MRD Study
The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors.
- Conditions
- Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer, Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, Melanoma (Skin Cancer)
- Trial name
- NCT06605404
- Testing
- blood and tissue samples
- Where
- 47 sites in United States
- Volunteers
- 1,350 people
- Sponsor
- Paradigm Health
Urinary Bladder Neoplasms, Non-muscle Invasive Bladder Cancer (NMIBC)
A Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer
The goal of this clinical trial is to learn if the drug Alpha1H works to treat low-to-intermediate risk non-muscle-invasive bladder cancer in adults. It will also learn about the safety of drug Alpha1H.
- Trial name
- NCT07804056
- Testing
- Alpha1H, Transurethral Resection of Bladder Tumor (TURBT), Intravesical Chemotherapy
- Where
- Czechia
- Volunteers
- 194 people
- Sponsor
- Hamlet Pharma AB
Urinary Bladder Neoplasms, Carcinoma in Situ
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC).
- Conditions
- Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT05014139
- Testing
- Enfortumab vedotin
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 37 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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.
Urinary Bladder Neoplasms, Muscle-Invasive Bladder Cancer
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult…
- Trial name
- NCT03661320
- Testing
- Nivolumab, Gemcitabine, Cisplatin
- Where
- 172 sites in United States, Argentina and 26 more
- Volunteers
- 855 people
- Sponsor
- Bristol-Myers Squibb
Papillary-Only Non-muscle-invasive Bladder Cancer
A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC
This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with…
- Trial name
- NiBladder 2 (NCT07726992)
- Testing
- SHR-1501+BCG
- Where
- 2 sites in China
- Volunteers
- 750 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Bladder Cancer, Non-muscle Invasive Bladder Cancer
Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy
Blue light cystoscopy (BLC) is a diagnostic procedure in bladder cancer where the inside of the bladder is observed with a camera to detect bladder lesions.
- Trial name
- ENAiBLE (NCT07144319)
- Where
- 8 sites in United States, Belgium and 3 more
- Volunteers
- 500 people
- Sponsor
- Photocure
High-risk Non-muscle-invasive Bladder Cancer
A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy
This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder…
- Trial name
- NCT07468851
- Testing
- HS-10566
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
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.
Non Muscle Invasive Bladder Cancer
A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC
This is a prospective, single-arm study evaluating the safety and efficacy of NDV01 KIT, a fixed-dose combination of gemcitabine HCl and docetaxel, administered via intravesical instillation in patients with high-grade Non-Muscle…
- Trial name
- NMIBC (NCT06663137)
- Testing
- NDV01 intravesical controlled release formulation of gemcitabine and docetaxel
- Where
- Israel
- Volunteers
- 70 people
- Sponsor
- Relmada Therapeutics, Inc.
Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
Study REL-NDV01-303 is a Phase 3, open-label, multi-center study to determine the safety and efficacy of NDV-01 in adult participants with NMIBC.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
- Trial name
- RESCUE (NCT07464145)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Volunteers
- 393 people
- Sponsor
- Relmada Therapeutics, Inc.
Non-muscle Invasive Bladder Cancer
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).
- Trial name
- ADVANCED-2 (NCT05951179)
- Testing
- TARA-002
- Where
- 78 sites in United States, Argentina and 5 more
- Volunteers
- 131 people
- Sponsor
- Protara Therapeutics
Urinary Bladder Neoplasms, Neoplasm Metastasis
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer.
- Conditions
- Urinary Bladder Neoplasms, Neoplasm Metastasis, Ureteral Neoplasms
- Trial name
- FORAGER-1 (NCT05614739)
- Testing
- Vepugratinib, Pembrolizumab, enfortumab vedotin
- Where
- 82 sites in United States, Australia and 12 more
- Volunteers
- 677 people
- Sponsor
- Eli Lilly and Company
Non-muscle Invasive Bladder Cancer (NMIBC)
Evaluating the Safety and Performance of the Eight Medical Hyperthermia System IV 1.0 for HIVEC in NMIBC.
The goal of this clinical trial is to evaluate the safety and performance of the Eight Medical Hyperthermia System IV 1.0 when used to deliver recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) in…
- Trial name
- NCT07758881
- Testing
- Hyperthermic intravesical chemotherapy (HIVEC)
- Where
- 2 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- Eight Medical International BV
Non-Muscle- Invasive Bladder Cancer
BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants
The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed…
- Trial name
- PATAPSCO (NCT05943106)
- Testing
- Durvalumab, BCG
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- AstraZeneca