DOVE

  • Research type

    Research Study

  • Full title

    A three-arm randomized phase II study of Dostarlimab alone or with Bevacizumab versus nonplatinum chemotherapy in recurrent gynecological clear cell carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 study)

  • IRAS ID

    1008886

  • Contact name

    Katie Wilkinson

  • Contact email

    ctc.dove@ucl.ac.uk

  • Sponsor organisation

    Severance Hospital, Yonsei health System

  • Clinicaltrials.gov Identifier

    NCT06023862

  • Research summary

    DOVE is a gynaecological cancer study using two drugs, called Dostarlimab and Bevacizumab. The UK target accrual is 20 (198 Globally) and the study will be run at 1 hospital. Eligible participants will have gynaecological clear cell cancer (GCCC), have received at least one previous treatment for their disease, and whose disease has come back (recurrent). GCCC is a rare type of cancer and the usual treatment is non-platinum chemotherapy. However, this type of cancer doesn't usually respond well to chemotherapy meaning there are fewer treatment options available. This study aims to investigate whether giving Dostarlimab alone, or together with Bevacizumab, can work better than non-platinum chemotherapy.

    Women who consent to take part, will be randomised into 1 of 3 groups:
    1) ARM A: patients will be given Dostarlimab alone, through intravenous (IV) infusions every 3 weeks for the first 4 courses, then every 6 weeks for up to 2 years.
    2) ARM B: patients will be given both Dostarlimab and Bevacizumab together. Dostarlimab treatment will be given as described for ARM A. Bevacizumab will be given through IV infusions every 3 weeks until the cancer starts growing again (progression).
    3) ARM C (standard treatment): patients will be given non-platinum chemotherapy until progression. The chemotherapy drug given will be decided by the treating clinician from one of four options: Liposomal Doxorubicin (PLD), Doxorubicin Hydrochloride, Paclitaxel, or Gemcitabine.
    The drug may be stopped for the following reasons: if there is an unacceptable side effect, the treating clinician's decision, or if disease becomes worse while taking the study treatment. After end of treatment, patients will be followed up every 6 weeks for 2 years, then every 12 weeks until the disease returns. Blood and biopsy samples will be collected throughout the study.
    The study is funded by GlaxoSmithKline, sponsored by Yonsei University, South Korea, and coordinated by CRUK & UCL CTC, UK.

  • REC name

    East of England - Cambridge South Research Ethics Committee

  • REC reference

    25/EE/0176

  • Date of REC Opinion

    2 Oct 2025

  • REC opinion

    Further Information Favourable Opinion