Clinical Trials List
2021-08-01 - 2029-12-31
Phase III
Recruiting5
ICD-10C67.0
Malignant neoplasm of trigone of bladder
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9188.0
Malignant neoplasm of trigone of urinary bladder
A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hsi-Chin Wu 無
- Chi-Ping Huang 無
- Po-Jen Hsiao 無
- Ching-Chan Lin 無
- Yi-Huei Chang 無
- Su-Peng Yeh 無
- 謝德鈞 無
- Che-Hung Lin 無
- Han Chang 無
- Chi-Rei Yang 無
- Po-Fan Hsieh 無
- Yu-De Wang 無
- Wei-Ching Lin 無
- 陳冠亨 無
- 葉進仲醫師 Division of Urology
- Chin-Chung Yeh 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
注射劑
注射劑
Active Ingredient
Tremelimumab
Enfortumab Vedotin
Dosage Form
270
270
Dosage
25 mg/vial
20 mg/vial
Endpoints
• Evaluate the safety and tolerability of durvalumab + tremelimumab + EV in MIBC patients who are ineligible for cisplatin treatment.
Main Trial
• Compare the efficacy (i.e., EFS) of durvalumab + tremelimumab + EV (Group 1) versus cystectomy (Group 3), and of durvalumab + EV (Group 2) versus cystectomy (Group 3).
Inclution Criteria
Histologically or cytologically documented muscle-invasive UC of the bladder.
Participants with transitional cell and mixed transitional/non-transitional cell histologies;
Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0 (participants with T1 stage are allowed only with N1 disease)
Participants should also have not received prior systemic chemotherapy or immunotherapy for the treatment of MIBC or bladder UC.
Medically fit for cystectomy and able to receive neoadjuvant therapy;
Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC;
ECOG performance status of 0,1,2 at enrollment.
Availability of tumor sample prior to study entry;
Must have a life expectancy of at least 12 weeks at randomization.
Cisplatin-ineligible, following criteria based on Galsky et al 2011 OR Refuse cisplatin based chemotherapy (must be documented in the medical records)
Exclusion Criteria
Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening.
Active infection
Uncontrolled intercurrent illness
Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti--PD-1, anti PD-L1, or anti-PD-L2 antibodies.
Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs.
The Estimated Number of Participants
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Taiwan
26 participants
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Global
943 participants
