10 recruiting, 7 not yet recruiting, 5 completed, 1 active not recruiting. 11 Phase 1, 9 Phase 2, 4 Not applicable, 3 Phase 3.
Follow NMIBC: new trials by email Literature Review of NMIBC trials Research Report on NMIBC
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC) This is a non-interventional, observational, prospective study. - NMIBC, MIBC | Not yet recruiting | Bladder Cancer Advocacy Network | 1400 | 2027-03-01 | 2026-10-26 | |
| Trop2-Targeted Near-Infrared Fluorescence Imaging-Guided Precise Resection of Non-Muscle Invasive Bladder Cancer TTP-ICG NIR fluorescent diagnostic agent - NMIBC | Phase 1 / Phase 2 | Not yet recruiting | Yunnan Cancer Hospital | 30 | 2026-10-30 | 2026-09-24 |
| Feasibility of Automatic, Laser-based Distance Control in Persons With Superficial Bladder Tumors ATLAS system - NMIBC | Not applicable | Recruiting | Optheras AS | 25 | 2026-10-02 | 2026-10-06 |
| A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC UGN-501 - Bladder (Urothelial, Transitional Cell) Cancer, NMIBC | Phase 1 | Recruiting | UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd. | 30 | 2026-09-28 | 2026-10-13 |
| Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC) Non-Muscle Invasive Bladder Cancer, NMIBC | Recruiting | Natera, Inc. | 400 | 2026-07-27 | 2026-08-13 | |
| A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC SHR-1501 for Injection, BCG for Injection, Epirubicin Hydrochloride for Injection - NMIBC | Phase 3 | Recruiting | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | 236 | 2026-07-13 | 2026-07-20 |
| ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer BCG (50 mg) plus ANKTIVA (400 µg), BCG (50 mg) - NMIBC | Phase 3 | Withdrawn | ImmunityBio, Inc. | 2026-05-15 | 2026-05-19 | |
| The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG. SPGL008 - NMIBC | Phase 1 / Phase 2 | Not yet recruiting | Shenyang Sunshine Pharmaceutical Co., LTD. | 120 | 2026-03-12 | 2026-03-03 |
| DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC Active Comparator: BCG induction and maintenance, DV + BCG induction and maintenance - Bladder (Urothelial, Transitional Cell) Cancer, NMIBC | Phase 3 | Recruiting | Fudan University | 182 | 2025-12-01 | 2026-07-21 |
| ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG Intravesical Recombinant Mycobacterium (rMBCG) - NMIBC | Phase 1 / Phase 2 | Recruiting | ImmunityBio, Inc. | 40 | 2025-10-15 | 2026-03-27 |
| Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial Spinal Anesthesia, General Anesthesia - NMIBC, TURBT | Not applicable | Not yet recruiting | National Taiwan University Hospital | 370 | 2025-08-01 | 2025-05-21 |
| A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC. Gemcitabine + BCG, BCG (TICE strain) - NMIBC, Non-Muscle Invasive Bladder Urothelial Carcinoma | Phase 1 / Phase 2 | Not yet recruiting | Queen's University | 31 | 2025-08-01 | 2025-07-17 |
| A Bladder-Sparing Treatment Strategies of Large-Volume Non-Muscle-Invasive Bladder Cancer bladder sparing set, RC - Bladder Cancer, NMIBC | Not applicable | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 60 | 2024-12-01 | 2025-03-18 |
| SHR-1501 Combined With SHR-2005 for High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt SHR-1501+SHR-2005 - NMIBC | Phase 1 / Phase 2 | Not yet recruiting | Fudan University | 58 | 2024-10-01 | 2024-09-19 |
| A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk. Distitamab Vedotin in combination with Tislelizumab - NMIBC | Phase 2 | Not yet recruiting | Fujian Medical University Union Hospital | 40 | 2024-10-01 | 2024-10-10 |
| Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer Immediate postoperative chemotherapy - NMIBC | Not applicable | Recruiting | Changhai Hospital | 72 | 2024-06-01 | 2025-03-21 |
| A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD) NMIBC, MIBC | Recruiting | Peking University First Hospital | 300 | 2024-03-01 | 2025-05-28 | |
| A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer ZH9 - NMIBC, High Risk NMIBC | Phase 1 | Completed | Prokarium Ltd | 22 | 2024-01-08 | 2026-10-14 |
| RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects RC48-ADC in Combination with gemcitabine - NMIBC | Phase 2 | Recruiting | RemeGen Co., Ltd. | 85 | 2023-06-08 | 2023-07-13 |
| A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer AU-011, AU-011 in Combination with Medical Laser Adminstration, AU-011 in Combination with Medical Laser Administration - Non-muscle-invasive Bladder Cancer, NMIBC | Phase 1 | Active not recruiting | Aura Biosciences | 55 | 2022-09-26 | 2026-08-06 |
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Non-Muscle Invasive Bladder Neoplasms (26) · Urinary Bladder Neoplasms (9) · Neoplasms (5) · Carcinoma, Transitional Cell (2) · Recurrence (2) · Carcinoma in Situ (1) · Disease Progression (1)
Carcinoma (26) · Female Urogenital Diseases (26) · Female Urogenital Diseases and Pregnancy Complications (26) · Male Urogenital Diseases (26) · Neoplasms by Histologic Type (26) · Neoplasms by Site (26) · Neoplasms, Glandular and Epithelial (26) · Urinary Bladder Diseases (26) · Urogenital Diseases (26) · Urogenital Neoplasms (26) · Urologic Diseases (26) · Urologic Neoplasms (26) · Neoplasms (21) · Urinary Bladder Neoplasms (17) · Disease Attributes (2)
Gemcitabine (4) · Anesthesia, General (1) · Anesthesia, Spinal (1) · BCG Vaccine (1) · Epirubicin (1) · Imiquimod (1) · Injections (1) · Maintenance (1) · Mitomycin (1) · Prospective Studies (1) · enfortumab vedotin (1) · hydroxycamptothecinum (1) · pemigatinib (1) · pirarubicin (1) · tislelizumab (1)
ImmunityBio, Inc. (3) · Fudan University (2) · Astellas Pharma Global Development, Inc. (1) · Aura Biosciences (1) · Bladder Cancer Advocacy Network (1) · Changhai Hospital (1) · Ding-Wei Ye (1) · Fujian Medical University Union Hospital (1) · Insel Gruppe AG, University Hospital Bern (1) · Natera, Inc. (1) · National Taiwan University Hospital (1) · Optheras AS (1) · Peking University First Hospital (1) · Prokarium Ltd (1) · Queen's University (1)
China (10) · United States (10) · Canada (2) · Spain (2) · Australia (1) · Denmark (1) · France (1) · Germany (1) · Italy (1) · Taiwan (1) · United Kingdom (1)
Sebastian Mirkin, MD (2) · Dingwei Ye, MD (1) · Josefin-Beate Holz, MD (1) · Noah M Hahn, MD (1) · Shuxiong Zeng, M.D. Ph.D (1) · Yair Lotan, MD (1)
PMID 28705539, PMID 29801011, PMID 34511303, PMID 37414705, PMID 38142702, PMID 41314851
2023 (1)