Study of intravesical enfortumab vedotin for treatment of patients with NMIBC

• Research type

  Research Study

• Full title

  A study of intravesical enfortumab vedotin for treatment of patients with non-muscle invasive bladder cancer (NMIBC)

• IRAS ID

  1003947

• Contact name

  Sujata Narayanan

• Contact email

  EU-Regulatory@seagen.com

• Sponsor organisation

  Seagen Inc.

• Eudract number

  2021-001287-22

• Research summary

  This study is being carried out to test if Study drug Enfortumab Vedotin (EV) is safe and effective for the treatment of non-muscle invasive bladder cancer (NMIBC). EV is a type of drug called an antibody drug conjugate (ADC). ADCs usually have 2 parts –antibody and drug.
  Antibodies are part of our immune system to help protect against infection and the drug component are designed to target specific cancer cells so that the drug part can be absorbed into the cancer cells causing cell death. This is an open label study, which means both the participants and study team know what drug is being given. About 58 people will take part in this clinical trial. EV will be given once a week for 6 weeks during the first part of the study and then it will be given monthly for a total of 9 more doses. EV will be given inside the bladder using a thin tube called a catheter. All Participants will have various procedures throughout the study including urinalysis, blood samples, scans, ECGs and tumour biopsies. Participants will continue to receive study treatment and safety assessment until disease progression, toxicity, investigators decision or withdrawal of consent. After treatment discontinuation, all patients will be followed for subsequent cancer therapies and survival. Study has 2 Parts: A and B. Part A- The maximum tolerated dose (MTD - The highest dose of a drug or treatment that does not cause unacceptable side effects) of EV in participants with NMIBC will be identified. Part B:The recommended dose of EV for further testing and/or the treatment of patients with NMIBC. This study is being sponsored by Seagen, Inc. EV has been approved for sale in the USA for adults with advanced bladder cancer and urinary tract cancer that has spread or cannot be removed by surgery. This will be the first time where EV is given inside the bladder.

• REC name

  Fast Track REC

• REC reference

  21/FT/0101

• Date of REC Opinion

  23 Sep 2021

• REC opinion

  Unfavourable Opinion