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Clinical trials for enfortumab vedotin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43854   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    9 result(s) found for: enfortumab vedotin. Displaying page 1 of 1.
    EudraCT Number: 2018-003809-26 Sponsor Protocol Number: MK-3475-905 Start Date*: 2019-07-01
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Randomized Phase 3 Study Evaluating Cystectomy with Perioperative Pembrolizumab and Cystectomy with Perioperative Enfortumab Vedotin and Pembrolizumab versus Cystectomy Alone in Participants who ...
    Medical condition: Muscle-invasive Bladder Cancer (MIBC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10022877 Invasive bladder cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing) GB (GB - no longer in EU/EEA) IE (Trial now transitioned) DK (Trial now transitioned) HU (Ongoing) DE (Trial now transitioned) BE (Ongoing) ES (Ongoing) PL (Trial now transitioned) FR (Trial now transitioned) IT (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2020-005452-38 Sponsor Protocol Number: D910PC00001 Start Date*: 2022-07-28
    Sponsor Name:AstraZeneca AB
    Full Title: 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 En...
    Medical condition: Documented muscle-invasive urothelial carcinoma (UC) of the bladder in cisplatin ineligible patients or Who Refuse Cisplatin
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005004 Bladder cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Ongoing) PT (Ongoing) AT (Ongoing) PL (Ongoing) NL (Ongoing) IT (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2020-003106-31 Sponsor Protocol Number: MK-3475-B15 Start Date*: 2021-04-27
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants wit...
    Medical condition: Urothelial Carcinoma and Muscle Invasive Bladder Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10064467 Urothelial carcinoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) CZ (Trial now transitioned) PT (Trial now transitioned) GR (Restarted) BG (Trial now transitioned) IT (Restarted) RO (Ongoing) HU (Ongoing) HR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003344-21 Sponsor Protocol Number: 7465-CL-0301 Start Date*: 2019-05-27
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects with Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
    Medical condition: Locally advanced or metastatic urothelial cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) BE (Completed) AT (Completed) DK (Completed) GB (GB - no longer in EU/EEA) NL (Completed) PT (Ongoing) IT (Restarted)
    Trial results: View results
    EudraCT Number: 2017-004634-28 Sponsor Protocol Number: WO39613 Start Date*: 2019-07-11
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN CISPLATIN-INELIGIBLE PATIENTS WITH LOC...
    Medical condition: Urothelial carcinoma (UC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) GB (GB - no longer in EU/EEA) ES (Ongoing) GR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004542-15 Sponsor Protocol Number: SGN22E-003 Start Date*: 2020-08-03
    Sponsor Name:Seattle Genetics, Inc.
    Full Title: An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab with or without chemotherapy, versus chemotherapy alone in previously untreated locally a...
    Medical condition: Urothelial cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    20.0 100000004864 10046723 Urothelial carcinoma ureter LLT
    20.0 100000004864 10046728 Urothelial carcinoma urethra LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) NL (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) HU (Ongoing) DK (Trial now transitioned) IT (Restarted) PL (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-001371-14 Sponsor Protocol Number: MK-3475-04B Start Date*: 2023-09-21
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 1/2 Randomized, Umbrella Study to Evaluate the Safety and Efficacy of Pembrolizumab Plus Enfortumab Vedotin (EV) in Combination With Investigational Agents Versus Pembrolizumab Plus EV, as ...
    Medical condition: Locally advanced/unresectable or metastatic urothelial carcinoma previously untreated for their advanced disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) NL (Trial now transitioned) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002964-29 Sponsor Protocol Number: IMMU-132-13 Start Date*: 2021-10-12
    Sponsor Name:Gilead Sciences Inc
    Full Title: A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cancer
    Medical condition: Metastatic or Locally Advanced Unresectable Urothelial Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10077840 Urothelial cancer of renal pelvis LLT
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    20.0 100000004864 10046723 Urothelial carcinoma ureter LLT
    20.0 100000004864 10046728 Urothelial carcinoma urethra LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing) PT (Completed) BE (Ongoing) AT (Ongoing) IT (Ongoing) IE (Ongoing) HU (Completed) BG (Ongoing) CZ (Completed) HR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003653-29 Sponsor Protocol Number: BT5528-100 Start Date*: 2020-10-09
    Sponsor Name:Bicycle Tx Limited
    Full Title: Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients with Advanced Malignancies Associated with EphA2 Expression
    Medical condition: Advanced Malignancies Associated with EphA2 Expression
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Ongoing) ES (Ongoing)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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