Clinical trials: MIBC
Urinary Bladder Neoplasms
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)
Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of cancer that has not spread from the muscles in the bladder to other parts of the body.
- Trial name
- NCT04241185
- Testing
- Pembrolizumab, Conventional Radiotherapy (Bladder only), Conventional Radiotherapy (Bladder and pelvic nodes)
- Where
- 134 sites in United States, Australia and 23 more
- Volunteers
- 520 people
- Sponsor
- Merck Sharp & Dohme LLC
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
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
Urinary Bladder Cancer, Muscle-invasive
Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).
- Trial name
- NCT03924895
- Testing
- Pembrolizumab, Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]), Enfortumab Vedotin
- Where
- 242 sites in United States, Argentina and 26 more
- Volunteers
- 595 people
- Sponsor
- Merck Sharp & Dohme LLC
Bladder Cancer, Urothelial Carcinoma
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Renal Pelvis Carcinoma
- Trial name
- ATLAS (NCT03397394)
- Testing
- Rucaparib
- Where
- 64 sites in United States, France and 4 more
- Volunteers
- 97 people
- Sponsor
- pharmaand GmbH
Urothelial Bladder Cancer
Enfortumab Vedotin + Pembrolizumab Induction to Spare the Bladder in MIBC
This is a Phase 2 clinical intervention trial to assess efficacy of induction EVP to spare the bladder in stage T2-4aN0-1 urothelial bladder cancer (UBC), using a response-adapted approach
- Trial name
- FIDELIO (NCT07663747)
- Testing
- Enfortumab Vedotin, Pembrolizumab, Radiation
- Where
- 3 sites in Netherlands
- Volunteers
- 56 people
- Sponsor
- The Netherlands Cancer Institute
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
Bladder Cancer
Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
- Trial name
- KEYNOTE-866 (NCT03924856)
- Testing
- Pembrolizumab, Gemcitabine, Cisplatin
- Where
- 175 sites in United States, Australia and 20 more
- Volunteers
- 907 people
- Sponsor
- Merck Sharp & Dohme LLC
Bladder Cancer, Bladder Tumor
A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk…
- Conditions
- Bladder Cancer, Bladder Tumor, Muscle-Invasive Bladder Cancer
- Trial name
- NCT04209114
- Testing
- Nivolumab, Radical cystectomy (RC), Bempegaldesleukin
- Where
- 116 sites in United States, Argentina and 18 more
- Volunteers
- 114 people
- Sponsor
- Bristol-Myers Squibb
Non-Muscle Invasive Bladder Neoplasms
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and evaluate preliminary clinical efficacy.
- Trial name
- NCT05316155
- Testing
- Erdafitinib Intravesical Delivery System
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 235 people
- Sponsor
- Janssen Research & Development, LLC
MIBC
Neoadjuvant RC48 Plus Gemcitabine in HER2-Expressing MIBC
Objectives: To evaluate the non-inferiority of disitamab vedotin plus gemcitabine versus disitamab vedotin plus toripalimab in terms of the pathological complete response (pCR) rate as neoadjuvant therapy for muscle-invasive…
- Trial name
- NCT07693959
- Testing
- Gemcitabine, Toripalimab, Disitamab Vedotin (RC48)
- Where
- 22 sites in China
- Volunteers
- 170 people
- Sponsor
- Zhiquan Hu
Muscle-Invasive Bladder Carcinoma, Tumor
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO)…
- Trial name
- NCT06417190
- Testing
- Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Leslie Ballas
NMIBC, MIBC
A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD)
This was a multicenter, prospective, non-interventional, observational cohort study, and the enrolled patients were divided into four cohorts: cohort I was patients with high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or…
- Conditions
- NMIBC, MIBC, UTUC
- Trial name
- NCT06991868
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Peking University First Hospital
Bladder Cancer
Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location
VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion…
- Trial name
- VI-RADS (NCT06337591)
- Testing
- VI-RADS
- Where
- 3 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
Mibc, Muscle Invasive Bladder Cancer
Sasanlimab As Maintenance Treatment Based on Clinical Response to Neoadjuvant Treatment in Molecularly Categorized Muscle Invasive Bladder Cancer Patients
Selective Bladder-Sparing Trial with Sasanlimab as Maintenance Treatment Based On Clinical Response To Neoadjuvant Treatment In Molecularly Categorized Muscle Invasive Bladder Cancer Patients
- Trial name
- SASAN-SPARING (NCT06623162)
- Testing
- gemcitabine + cisplatine
- Where
- Spain
- Volunteers
- 70 people
- Sponsor
- Fundación de investigación HM
Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Requiring Cystectomy
Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer
The TEMPO-MIBC trial is a phase III, single-center, two-arm, randomized, controlled trial. Its primary objective is to evaluate the efficacy of a simplified diagnostic and treatment pathway for muscle-invasive bladder cancer…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Requiring Cystectomy, Bladder Carcinoma, Bladder Neoplasm
- Trial name
- TEMPO-MIBC (NCT07067749)
- Testing
- multiparametric magnetic resonance imaging (mpMRI) of the bladder, Transurethral resection of bladder tumour (TURBt), Circulating tumour DNA levels assessment
- Where
- Italy
- Volunteers
- 92 people
- Sponsor
- University of Rome Tor Vergata
Patients With High-risk MIBC
Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer (GETUG-AFU 30)
This is a randomized multicentre study in patients with high-risk MIBC to investigate adjuvant radiotherapy after radical cystectomy and pelvic lymph node dissection.
- Trial name
- Bladder-ART (NCT03333356)
- Testing
- pelvic radiotherapy
- Where
- 17 sites in France
- Volunteers
- 81 people
- Sponsor
- UNICANCER
Bladder Cancer, Muscle Invasive Bladder Cancer
Avelumab and Radiation in Muscle-Invasive Bladder Cancer
This research study is studying the effects of adding a certain type of immunotherapy to standard bladder-directed radiation as a treatment for muscle-invasive urothelial carcinoma of the bladder.
- Trial name
- NCT03747419
- Testing
- Avelumab, Radiation
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Dana-Farber Cancer Institute
Muscle Invasive Bladder Cancer
Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer
This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, Phase 1b study in patients with muscle invasive bladder cancer (MIBC) (urothelial) who have progressed on prior treatment.
- Trial name
- BISCAY (NCT02546661)
- Testing
- AZD4547, MEDI4736, Olaparib
- Where
- 27 sites in United States, Canada and 3 more
- Volunteers
- 117 people
- Sponsor
- AstraZeneca