A study of pembrolizumab and usual treatment for cervical cancer (The Papaya Study)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Cervical cancer

Status:

Closed

Phase:

Phase 1

This study is looking at whether pembrolizumab can improve treatment for cancer of the cervix.

More about this trial

Doctors often treat cervical cancer with a combination of chemotherapy and radiotherapy. This is called chemoradiation.It is standard treatment for cervical cancer. 
 
But sometimes the cancer continues to grow. So, researchers are looking for ways to improve treatment. In this study they are looking at a drug called pembrolizumab.
 
Pembrolizumab is a type of immunotherapy It works by helping the immune system to recognise and attack cancer cells. 
 
The main aims of this study are to:
  • see if adding pembrolizumab to standard treatment keeps the cancer under control for longer
  • learn more about the side effects

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. 
You:
  • have cancer in the neck of the womb that is more than 7mm across or has spread to nearby organs in the pelvis such as the bladder or rectum but hasn’t spread to other parts of the body (stage 1B to stage 4A)
  • have cancer that your doctor can measure on a scan
  • are suitable to have a chemotherapy drug called cisplatin
  • have satisfactory blood test results
  • are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • are willing to use at least 2 types contraception if there is any chance that you could become pregnant 
  • are at least 18 years old
Who can’t take part
 
You cannot join this study if any of these apply. 
 
Cancer related
You:
  • have had other treatment such as monoclonal antibodies chemotherapy, targeted drugs or radiotherapy in the past
  • have had a type of immunotherapy that targets certain immune cells such as pembrolizumab in the past 
  • have had previous radiotherapy to your pelvis (area between your hip bones)
  • have had part of your bowel removed 
  • are taking part in a clinical trial with an experimental drug or device in the 4 weeks before starting treatment in this study
  • have another cancer that needs treatment apart from basal cell skin cancer, squamous cell skin cancer or carcinoma insitu of the cervix that has been successfully treated
Medical conditions
You:
  • have a problem with how your kidneys work which means you can’t have cisplatin chemotherapy
  • have a problem with how your immune system works, you are having steroid treatment apart from creams or inhalers or you are taking drugs that suppress your immune system within 7 days of starting study treatment
  • have had major surgery and haven’t fully recovered from the side effects or complications 
  • have had inflammatory bowel disease such as Crohn’s or an autoimmune disease in the past
  • have an active autoimmune disease that needed treatment that reached the whole body in the last 3 months or you have a severe autoimmune disease. You may be able to take part if you have too little thyroid hormones made by the thyroid gland (hypothyroidism) that needs hormone replacement
  • have or have had a condition causing inflammation of your lungs called pneumonitis
  • have TB that is causing symptoms 
  • have an infection that needs treatment 
  • have HIV
  • have an active hepatitis B or hepatitis C infection
  • have any other medical condition or mental health problem that the study team think would affect you taking part in this study 
Other
You:
  • have a problem with drugs and alcohol
  • are planning to become pregnant, pregnant or breastfeeding
  • have had a live vaccination in the 30 days before starting study treatment 

Trial design

This is a phase 1 study. The researchers need 26 women to take part. The study is for women having treatment at the Royal Marsden Hospital in London and Sutton.
 
This study involves having:
  • standard treatment with a combination of radiotherapy and chemotherapy (chemoradiation)
  • pembrolizumab 
Standard treatment (chemoradiation)
Everybody taking part has a combination of chemotherapy and radiotherapy (chemoradiation). This takes 5 ½ weeks in total. 
 
You have both external radiotherapy and internal radiotherapy. External radiotherapy uses radiation from a machine outside your body. Internal radiotherapy involves having radiotherapy to the cancer from the inside. This treatment involves placing a tube inside the vagina and having radiotherapy through this. This is also called brachytherapy. 
 
Your doctor will give you more information about your radiotherapy plan and exactly how many treatments you have. 
 
You have a chemotherapy drug called cisplatin once a week for 4 weeks. You have it through a drip into a vein.
 
Pembrolizumab
You:
  • have your first dose of pembrolizumab (a loading dose) 1 to 2 weeks before starting chemoradiotherapy
  • then have it every 3 weeks until you have had 8 doses in total
You have it as a drip into a vein. It takes about 30 minutes each time. Treatment with pembrolizumab takes about 18 weeks (6 months). The researchers are looking at 2 different doses. The dose you have depends on when you join. The study team can tell you more about this. 
 
Quality of life
The study team will ask you to fill out a questionnaire before you start treatment, at set times during and after treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study
 
Research samples
You give some extra blood samples during treatment. You give the samples before you start pembrolizumab and when you finish radiotherapy. 
 
The researchers will also ask for a sample of your cancer from a previous surgery or a biopsy. They might also ask to take a new sample. You don’t have to agree to give these samples if you don’t want to. You can still take part in the study.
 
They plan to use the samples to: 
  • see how well the treatment is working 
  • find what happens to pembrolizumab in the body
  • look for biomarkers to predict who will benefit from treatment 

Hospital visits

You’ll see a doctor and have some tests before you join the study. These include:
You have all your treatment at the hospital. You see a doctor for a check up every 3 weeks each time you have pembrolizumab. The study team will also keep a close eye on you while you are having chemoradiotherapy. 
 
You have a CT scan:
  • when you finish external radiotherapy
  • when you finish pembrolizumab
  • and then, every 3 months until your cancer gets worse
You have a repeat smear test after you finish radiotherapy.
 
Follow up
You see a study doctor or nurse when you finish all treatment at:
  • 1 month 
  • 4 months
At each appointment you have a check up and some blood tests. After that the study team follow you up every 3 months for up to 2 years. 
 

Side effects

The most common side effects of pembrolizumab include:
The study doctors will explain all the possible side effects before you join the study. 
 
We have information about:

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Susan Lalondrelle

Supported by

Biomedical Research Centre (BRC)
Merck, Sharpe & Dohme
Royal Marsden NHS Foundation Trust

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15406

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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