A three-arm randomised phase II study of dostarlimab alone or with bevacizumab versus non-platinum chemotherapy in recurrent clear cell carcinoma.
Who can take part
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
You may be eligible to take part in this trial if you:
- are aged 18 years and over
- are in good general physical health
- have recurrent or persistent clear cell carcinoma of the ovary
- have disease progression within 12 months of completing platinum-based chemotherapy (carboplatin or cisplatin)
- have disease on scan that can be measured
- have tumour tissue available for translational research or consent to having a new biopsy taken.
This is not an exhaustive list. If you're interested in participating in a clinical trial, you should speak to your doctor about what other criteria might apply.
About the trial
This trial is for those with a diagnosis of clear cell carcinoma that has recurred (come back). It is an open label study, which means both you and the doctor know what treatment you are receiving.
Clear cell carcinoma (CCC) is a rare subtype of ovarian cancer. Treatment for recurrent CCC is usually chemotherapy. The researchers conducting the trial are looking at testing a drug called Dostarlimab on its own and in combination with Bevacizumab to see how well they work for this type of ovarian cancer in comparison to standard chemotherapy drugs.
The drugs being tested in this trial are:
- Dostarlimab – a type of immunotherapy called a monoclonal antibody. It helps the immune system to find and fight cancer (it is given via a drip into the vein)
- Bevacizumab –a targeted therapy that acts on a cancer cell protein called VEGF. This protein is needed by cancer cells to develop blood vessels so they can grow. Bevacizumab blocks this protein so the cancer’s blood supply is stopped, and the cells are starved of oxygen and food so they can’t grow back (it is given via a drip into the vein.)
DOVE has 3 different treatment arms and if you take part, you will be randomised (placed into a treatment group by a computer) into one of the treatment groups:
- Dostarlimab alone
- Dostarlimab and Bevacizumab
- Standard Chemotherapy - the most appropriate type of chemotherapy will be chosen by your doctor, it will be one of the following drugs:
- Doxorubicin (given via a drip into the vein)
- Gemcitabine (given via a drip into the vein)
- Paclitaxel (given via a drip into the vein)
- Pegylated liposomal doxorubicin (Caelyx) (given via a drip into the vein.)
If you are assigned Dostarlimab or a chemotherapy drug and your cancer gets worse during treatment the research team can decide to change your treatment to the combination of Dostarlimab and Bevacizumab.
All participants will be followed up by the research team.
