Duravelo 2

  • Research type

    Research Study

  • Full title

    A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)



  • Contact name

    Emma Gartside

  • Contact email


  • Sponsor organisation

    BicycleTx Ltd

  • Eudract number


  • Research summary

    There is a need for a safer and more effective therapy for patients with urothelial cancer (UC) that cannot be removed by surgery or has spread throughout the body (tumour on a bladder, portion of a kidney, or ureter or urethra). This goes for both patients who have already received treatment and patients who have never received therapy for such cancers.

    Gemcitabine in combination with either cisplatin or carboplatin is an approved and common chemotherapy for the treatment of tumours. Pembrolizumab is an approved treatment for, among others, locally advanced or metastatic UC in patients who cannot be treated with certain chemotherapy regimens. The research medicine, BT8009, will be given alone or with pembrolizumab depending on which group participants are placed in. Another control group will receive the approved chemotherapy regimen of gemcitabine with either cisplatin or carboplatin.

    The purpose of the study is to determine if and how well the research medicine BT8009 works against UC, when given alone or with pembrolizumab. The study also aims to understand whether BT8009 when given alone or with pembrolizumab can be given safely to people and how well they cope (tolerate) the treatment These treatments will be compared to the treatment with gemcitabine and platinum chemotherapy.

    In Cohort 1, participants will receive BT8009 in 21 day cycles (on days 1, 8, and 15 or on days 1 and 8) in combination with 200 mg of pembrolizumab on Day 1 of each cycle. In Cohort 2, participants will receive BT8009 as monotherapy or in combination with pembrolizumab.

    The total number of visits, procedures performed, and number of times a therapy is administered also depends on how long treatment is received before, for example, the tumour grows. There are short- and long-term safety follow-up periods for all patients. Total time on the study may last over 4 years, but some medicines will be stopped earlier

  • REC name

    West of Scotland REC 1

  • REC reference


  • Date of REC Opinion

    7 Mar 2024

  • REC opinion

    Further Information Favourable Opinion