Clinical Trials List
2026-08-28 - 2032-02-19
Phase III
Not yet recruiting6
A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/25
Investigators and Locations
Co-Principal Investigator
- 黃文冠 無
- 陳妙芬 無
- Kai-Jie Yu 無
- Yung-Chia Kao 無
- 蘇安琪 無
- 余紹銘 無
- See-Tong Pang 無
- 葉永堅 無
- 李宗霖 無
- Chun-Te Wu 無
- Yung-Chang Lin 無
- PO-HUNG LIN 無
- 張杰茵 無
- Hong-Cheng Gan 無
- 吳燿宇 無
- 陳柏叡 無
- I-hung Shao 無
- 詹頂立 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- - - 無
- Chia-Chi Lin 無
- PO-MING CHOW 無
- Yeong-Shiau Pu 無
- JIAN-HUA HONG 無
- 莊建淮 無
- - - 無
- FU-JEN HSUEH 無
- CHUNG-HSIN CHEN 無
- 吳書丞 無
- 闕士傑 無
- JHE-CYUAN GUO 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Cheng-Che Chen 無
- 林雁婷 無
- 洪晟鈞 無
- 裘坤元 無
- 張家程 無
- 張瓈文 無
- Chuan-Shu Chen 無
- 楊哲瑞 無
- 謝享宸 無
- 楊涵中 無
- Shian-Shiang Wang 無
- Cheng-Kuang Yang 無
- Jian-Ri Li 無
- JU-CHUAN HU 無
- 賴谷順 無
- 梅承恩 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 周楠華 無
- 蔡禮賢 無
- Hsi-Chin Wu 無
- Chi-Ping Huang 無
- Ching-Chan Lin 無
- 鄭富銘 無
- Che-Hung Lin 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Ching-Chia Li 無
- 李明儒 無
- Wen-Jeng Wu 無
- 張顥瀚 無
- Hsin-Chih Yeh 無
- Hsiang Ying Lee 無
- 阮雍順 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
注射劑
Active Ingredient
Pembrolizumab
Dosage Form
270
Dosage
100 mg/4 mL
Endpoints
• 整體存活期
Inclution Criteria
Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0
Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline
Eligible for and agree to receive chemoradiotherapy and one of the protocol-specified radiosensitizing chemotherapy regimens
Fit for systemic therapy and elect bladder preservation, including participants who are ineligible for or have elected not to undergo cystectomy
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Exclusion Criteria
Advanced or metastatic disease (N+, M1), non-urothelial carcinoma, diffuse or multifocal CIS, urothelial carcinoma or histological variant at any site outside the urinary bladder within previous 24 months prior to randomization except Ta/T1/CIS of the upper urinary tract including renal pelvis and ureter if the participant had undergone complete nephrectomy
Has received any prior systemic treatment, chemoradiation, and/or radiation for MIBC or NMIBC
Prior pelvic radiation for any reason
Inadequate bladder function
Other active malignancies within 3 years prior to randomization
Previously treated with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs)
Previously treated with a PD(L)-1 inhibitor, defined as a PD-1 inhibitor or PD-L1 inhibitor
Uncontrolled diabetes
Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted
Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection
Received major surgery (defined as requiring general anesthesia and >24 hour inpatient hospitalization) within 4 weeks prior to randomization
Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin
Known genetic disorders associated with radiosensitivity (eg, ataxia telangiectasia, Nijmegen breakage syndrome, Fanconi syndrome)
Active keratitis or corneal ulcerations
History of autoimmune disease that has required systemic treatment in the past 2 years
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Prior allogeneic stem cell or solid organ transplant
Received a live attenuated vaccine within 30 days prior to randomization
The Estimated Number of Participants
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Taiwan
24 participants
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Global
390 participants
