Clinical trials: Muscle-Invasive Bladder Cancer (MIBC)
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.
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
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, 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
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
Bladder Cancer
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current…
- Trial name
- KEYNOTE-B15 (NCT04700124)
- Testing
- Pembrolizumab, Enfortumab vedotin (EV), RC + PLND
- Where
- 188 sites in United States, Argentina and 27 more
- Volunteers
- 808 people
- Sponsor
- Merck Sharp & Dohme LLC
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
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
Clear Cell Renal Cell Cancer (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC)
A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors
The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of [68Ga]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC)…
- Conditions
- Clear Cell Renal Cell Cancer (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer (CRC), Urothelial Carcinoma (UC)
- Trial name
- NCT05706129
- Testing
- [68Ga]Ga-DPI-4452, [177Lu]Lu-DPI-4452
- Where
- 10 sites in Australia, France
- Volunteers
- 270 people
- Sponsor
- Lumara Bio Oncologics GmbH
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
Urinary Bladder Neoplasms
A Study of Radical Cystectomy in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) in Korea
The purpose of this study is to assess participant's overall well-being and the extent to which medical services are used by participants with non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC)…
- Trial name
- BC RC DB (NCT07735793)
- Volunteers
- 1 people
- Sponsor
- Janssen Korea, Ltd., Korea
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
Muscular Invasive Bladder Cancer (MIBC)
Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
In phase II, the main objective is to evaluate the efficacy of SHR-A2102 combined with Adebrelimab in the treatment of muscular invasive bladder cancer (MIBC); The main objective of phase III is to evaluate the efficacy of…
- Trial name
- NCT06879145
- Testing
- SHR-A2102；Adebrelimab
- Where
- China
- Volunteers
- 840 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Muscle-Invasive Bladder Cancer (MIBC)
A Prospective, Multi-Center, Phase 4, Single Arm Study To Assess The Safety and Tolerability of Perioperative Durvalumab in Combination With Neoadjuvant Gemcitabine Plus Cisplatin in Indian Patients With Muscle-Invasive Bladder Cancer Cle-Invasive
This is a Phase 4, Single Arm Study To Assess The Safety and tolerability of Perioperative Durvalumab in Combination with Neoadjuvant Gemcitabine Plus Cisplatin Treatment Followed by radical cystectomy and Durvalumab alone as…
- Trial name
- SERENE (NCT07876817)
- Testing
- Durvalumab, Gemcitabine, Cisplatin
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
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
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, 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
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
Urinary Bladder Neoplasms
A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.
- Trial name
- SunRISe-2 (NCT04658862)
- Testing
- Cetrelimab, TAR-200, Cisplatin
- Where
- 290 sites in United States, Argentina and 23 more
- Volunteers
- 518 people
- Sponsor
- Janssen Research & Development, LLC