A trial of pembrolizumab for ovarian cancer (PROMPT)

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this trial if you have one of the following cancers:

• ovarian cancer
• fallopian tube cancer
• primary peritoneal cancer  

And all of the following apply. You:

• have a high grade cancer that has come back after treatment with a platinum chemotherapy  such as carboplatin
• have had up to 3 different courses of treatment  containing a platinum drug before starting weekly paclitaxel 
• have had at least 4 cycles of treatment  with paclitaxel and have had a scan after that shows the paclitaxel is working
• can start pembrolizumab within 8 weeks after your last cycle of paclitaxel  
• have a sample of tissue (biopsy ) from when you were diagnosed that the trial team can access
• have an area of cancer where a fresh sample of tissue can be taken, you are willing to have this done when you join the trial and at another time during it. This is only done if your doctor thinks there is enough tissue to take a biopsy.
• are fully active but might not be able to do heavy physical work (performance status 0 or 1)
• have satisfactory blood test results
• are willing to use contraception during treatment and for 4 months after if there is any chance you could become pregnant
• are at least 18 years old 

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

• have a mucinous type of ovarian cancer, fallopian tube cancer or primary peritoneal cancer 
• have cancer that is low grade
• have had treatment with certain types of immunotherapy  drug. Your doctor can tell you more about this.
• have had other cancer treatments including experimental treatments as part of another clinical trial within 4 weeks of joining the trial
• have ongoing moderate to severe side effects from treatment  
• have had another cancer within the past 5 years apart from an early cancer  of the endometrium, in situ carcinoma  of the cervix and DCIS
• have cancer spread to the brain and spinal cord unless it has been treated, is not getting worse and you haven’t needed to take steroids for at least 2 weeks before the start of trial treatment

Medical conditions 
You cannot join this trial if any of these apply. You:

• have a low resistance to getting an infection (immunodeficiency) 
• are taking medication such as steroids that affect how well the immune system works within the 7 days before starting trial treatment apart from inhalers
• have or had tuberculosis (TB), hepatitis B, hepatitis C or HIV
• are having treatment for an active infection
• have an autoimmune disease  that needed treatment within the past 2 years apart from certain conditions. Your doctor can tell more about this. 
• have a newly diagnosed blood clot  (PE or DVT) unless you have been on medication such as warfarin for at least 2 weeks before starting trial treatment and can continue having it during
• have had symptoms of a blockage in your bowel in the past 3 months
• have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part

Other
You cannot join this trial if any of these apply. You:

• have a live vaccine  within 30 days of starting trial treatment
• are pregnant or breastfeeding