PROMPT: Phase II trial of maintenance pembrolizumab following weekly paclitaxel for recurrent ovarian, fallopian tube or peritoneal cancer
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 able to take part in this clinical trial if you:
- have high grade recurrent ovarian, fallopian tube or primary peritoneal cancer. Women with mucinous ovarian cancer are not eligible to take part
- have received a minimum of four cycles of weekly paclitaxel for a cancer that has returned and your cancer is stable or has shown a response
- have cancer that can be biopsied (if feasible) before the trial starts and after 4 doses of the trial treatment
- can start the trial within 8 weeks of having your last dose of chemotherapy.
- have a very good level of overall fitness and have blood test results within a certain range
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
Researchers are conducting the PROMPT trial to see if the study drug (pembrolizumab) can be used as a maintenance treatment to slow the growth/return of cancer after treatment with paclitaxel (standard chemotherapy drug). Normally, after receiving paclitaxel, patients are observed without treatment as maintenance treatment is not standard for this group of patients.
All women on the trial will receive the study drug pembrolizumab every three weeks, for a maximum of 24 months (two years), unless the following occur:
- the woman has unacceptable side effects
- the woman's disease worsens
- the woman wishes to stop treatment
- the treating clinician makes a clinical decision to stop the treatment
The drug involved in this trial is:
- Pembrolizumab – a type of immunotherapy drug. It's designed to stimulate the body’s immune system to 'see' and fight the cancer cells. It's approved in the UK as a prescription medicine (sometimes called KEYTRUDA®) to treat skin cancers called malignant melanoma, head and neck cancers, Hodgkin’s lymphoma and non-small cell lung cancer. It's not currently a standard treatment for ovarian cancer.
If you take part in this study, you'll receive 200mg pembrolizumab by IV infusion (via a needle into a vein) over 30 minutes once every three weeks.