Clinical trials: MIBC
MRI Contrast Media Adverse Reaction, Bladder Cancer
Can VI-RADS/ADC Accurately Stage Bladder Cancer??
Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet.
- Conditions
- MRI Contrast Media Adverse Reaction, Bladder Cancer, Bladder Disease, Bladder Neoplasm
- Trial name
- NCT04167631
- Testing
- Multi-parametric MRI
- Where
- Egypt
- Volunteers
- 150 people
- Sponsor
- Mansoura University
Muscle Invasive Bladder Cancer, HER2 Expression
RC48 Combined With Toripalimab and Radiotherapy for Bladder Sparing Treatment in MIBC
This is a prospective, open, single-center clinical study of RC48 combined with PD-1 and radiotherapy as bladder-preserving therapy in patients with muscular invasive bladder uroepithelial carcinoma with high HER-2 expression…
- Conditions
- Muscle Invasive Bladder Cancer, HER2 Expression, Radiotherapy, PD-1
- Trial name
- NCT05979740
- Testing
- Disitamab Vedotin and Toripalimab
- Where
- China
- Volunteers
- 6 people
- Sponsor
- RenJi Hospital
Bladder Cancer
Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC
This study assesses the effect of sequential radiation and durvalumab immunotherapy given as treatment prior to surgery with radical cystectomy for bladder cancer.
- Trial name
- RADIANT (NCT04543110)
- Testing
- Durvalumab, Immune Modulating Radiation
- Where
- 4 sites in Canada
- Volunteers
- 16 people
- Sponsor
- Ottawa Hospital Research Institute
Muscle-Invasive Bladder Cancer (MIBC)
Trastuzumab Rezetecan and Adebrelimab as Neoadjuvant Therapy for HER2-Positive Muscle-Invasive Bladder Cancer
This study aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer.
- Trial name
- NCT07624201
- Testing
- Trastuzumab Rezetecan Combined with Adebelizumab
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Harbin Medical University
Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the…
- Conditions
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms, Renal Pelvis Neoplasms
- Trial name
- EV-103 (NCT03288545)
- Testing
- enfortumab vedotin (EV), pembrolizumab, cisplatin
- Where
- 106 sites in United States, Canada and 4 more
- Volunteers
- 348 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Muscle-Invasive Bladder Cancer (MIBC)
Response-Guided Bladder Preservation With Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy in HER2-Expressing Muscle-Invasive Bladder Cancer
This prospective, multicenter, open-label phase II study will evaluate a response-guided bladder-preservation strategy in patients with HER2-expressing muscle-invasive bladder cancer.
- Trial name
- RG-BP-MIBC (NCT07865611)
- Testing
- Trastuzumab Rezetecan, Adebrelimab, Concurrent Bladder Radiotherapy
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Tongji Hospital
Muscle Invasive Bladder Cancer, Urothelial Carcinoma
Neoadjuvant Dose Dense MVAC in MIBC and Locally Advanced Urothelial Carcinoma
The objective is to investigate the efficacy and safety of four cycles of ddMVAC with G-CSF support in patients with MIBC and locally advanced UC
- Conditions
- Muscle Invasive Bladder Cancer, Urothelial Carcinoma, Neoadjuvant Chemotherapy
- Trial name
- NCT04047693
- Testing
- dose dense MVAC with pegylated GCSF
- Where
- South Korea
- Volunteers
- 24 people
- Sponsor
- Pusan National University Yangsan Hospital
Muscle-invasive Bladder Urothelial Carcinoma
A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer
This is a prospective, open-label, single-center, single-arm clinical study. Plans to enroll 45 MIBC patients with clinical stage T2-T4aN0M0 and HER2-positive (IHC 1+/2+/3+) status.
- Trial name
- NCT07279597
- Testing
- RC48-ADC + Toripalimab
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Tongji Hospital
Muscle Invasive Bladder Carcinoma
FL- 101 Study in Non-Metastatic MIBC
A pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy.
- Trial name
- NCT05395260
- Testing
- FL-101
- Sponsor
- Flame Biosciences
Urinary Bladder Neoplasms
HOPE-07-MIBC: Disitamab Vedotin Plus Immunotherapy vs Chemoimmunotherapy in Resectable HER2-Expressing MIBC
This is a multicenter, randomized controlled clinical trial (HOPE-07) designed to evaluate the efficacy and safety of perioperative treatment with disitamab vedotin (RC48) combined with toripalimab compared with toripalimab…
- Trial name
- HOPE-07-MIBC (NCT07608224)
- Testing
- Disitamab Vedotin (RC48), Gemcitabine + Cisplatin（GC）+Toripalimab, Toripalimab (JS001 )
- Volunteers
- 240 people
- Sponsor
- West China Hospital
Muscle Invasive Bladder Cancer
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer
- Trial name
- NIAGARA (NCT03732677)
- Testing
- Durvalumab, Cisplatin, Gemcitabine
- Where
- 188 sites in United States, Australia and 20 more
- Volunteers
- 1,063 people
- Sponsor
- AstraZeneca
Muscle-Invasive Bladder Cancer (MIBC)
EV + Toripalimab vs GC as Neoadjuvant Therapy in Locally Advanced/High-Risk MIBC
The purpose of this Phase II, open-label, multicenter, randomized controlled study is to evaluate the efficacy and safety of Enfortumab Vedotin in combination with Toripalimab compared to Gemcitabine plus Cisplatin.
- Trial name
- NCT07647289
- Testing
- enfortumab vedotin (EV), Toripalimab, Gemcitabine (Chemotherapy)
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Peking University Third Hospital
Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma (UC)
Immune-Stromal Landscape in Muscle-Invasive Bladder Cancer
Bladder cancer is a significant global health issue. When the cancer spreads into the muscle layer of the bladder (muscle-invasive bladder cancer), a common treatment is the surgical removal of the bladder (radical cystectomy).
- Conditions
- Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma (UC), Bladder Cancer, Muscle-Invasive Urothelial Bladder Carcinoma
- Trial name
- NCT07525349
- Volunteers
- 100 people
- Sponsor
- Assiut University
Muscle-Invasive Bladder Cancer (MIBC), Urinary Bladder Cancer
Multi-Omics-Based Phase Ⅱ Trial of Trastuzumab Rezetecan Plus Camrelizumab for Perioperative Therapy in HER2-Positive Muscle-Invasive Urothelial Carcinoma
For patients with HER2-expressing muscle-invasive bladder cancer (MIBC), current neoadjuvant therapies dominated by platinum-based chemotherapy remain unsatisfactory with respect to improved clinical efficacy, pathological…
- Trial name
- NCT07639983
- Testing
- Trastuzumab Rezetecan plus Camrelizumab
- Volunteers
- 44 people
- Sponsor
- Sheng Tai
Muscle-invasive Bladder Cancer
Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer
MIBC-PET is a prospective, monocentric, no-profit study with paired imaging comparison enrolling 60 patients with newly diagnosed, histologically confirmed high-grade MIBC.
- Trial name
- MIBC-PET (NCT07750470)
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- University Hospital of Ferrara
Muscle-invasive Bladder Cancer
Remodeling of MHC-related Immune Microenvironment in MIBC After Neoadjuvant Therapy
In this study, the relevant biomarkers for predicting the efficacy of neoadjuvant therapy in patients with MIBC were further explored.
- Trial name
- NCT07440901
- Testing
- Immunotherapy plus chemotherapy
- Volunteers
- 30 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Muscle Invasive Bladder Cancer (MIBC)
MRI-Guided Bladder Preservation Program For Patients With Muscle Invasive Bladder Cancer
The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of bladder preservation as well as to decrease complications in patients with muscle invasive bladder cancer who wish to retain…
- Trial name
- NCT07026864
- Testing
- MR-guided Radiation Therapy
- Volunteers
- 31 people
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
Muscle Invasive Bladder Cancer
A Study to Evaluate the Safety and Efficacy of Oral APL-1202 in Combination With Tislelizumab Compared to Tislelizumab Alone as Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer
This trial is designed to evaluate the safety, efficacy, and biomarker response of APL-1202 in combination with tislelizumab as neoadjuvant therapy for patients with MIBC who are cisplatin ineligible or refuse cisplatin-based…
- Trial name
- ANTICIPATE (NCT04813107)
- Testing
- APL-1202 in combination with tislelizumab, Tislelizumab alone
- Where
- 2 sites in United States, China
- Volunteers
- 79 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Bladder Cancer
Atezolizumab After Chemo-radiotherapy for MIBC Patients Not Eligible for Radical Cystectomy
Patients older than ≥18 years, with muscle-invasive bladder cancer unfit for radical cystectomy because of age, comorbidities, and/or patient's refusal. This study is designed as a multicentre, single-arm phase II study.
- Trial name
- BladderSpar (NCT03697850)
- Testing
- Atezolizumab
- Where
- 12 sites in France
- Volunteers
- 79 people
- Sponsor
- UNICANCER
Muscle-invasive Bladder Cancer
A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy
This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are…
- Trial name
- IMvigor011 (NCT04660344)
- Testing
- Atezolizumab, Signatera
- Where
- 141 sites in United States, Argentina and 21 more
- Volunteers
- 761 people
- Sponsor
- Hoffmann-La Roche