A trial of tiragolumab and atezolizumab for cervical cancer (SKYSCRAPER 04)

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 2

This trial is comparing having tiragolumab and atezolizumab with atezolizumab on its own for cervical cancer that has come back or spread.

More about this trial

Atezolizumab is an immunotherapy drug. It works by blocking a protein called PD-L1. By blocking PD-L1 atezolizumab could help the immune system Open a glossary item to find cancer cells and stop the growth of the cancer.

Doctors already use atezolizumab to treat some types of cancer that have the PD-L1 protein.

Tiragolumab is also an immunotherapy drug. It works by blocking a protein called TIGIT. By blocking TIGIT tiragolumab could also help the immune system recognise cancer cells and stop the growth of cancer.

We know that cervical cancer has the PD-L1 and TIGIT proteins. Researchers want to find out if atezolizumab on its own or atezolizumab with tiragolumab works for cervical cancer.

The main aims of this trial are to find:

how well atezolizumab on its own works
how well atezolizumab with tiragolumab works
out what the side effects are of these treatments

Who can enter

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 all of the following apply. You:

have a type of cervical cancer that is squamous cell, adenocarcinoma or adenosquamous carcinoma
have cancer that is growing or has come back after treatment, after having 1 or 2 different courses of treatment with chemotherapy that included a platinum drug
have cancer that can’t be treated with the aim to cure
have an area of cancer that is seen on a scan and the doctor can measure it
have satisfactory blood test results
are up and about but might not be able to do heavy physical work (performance status 0 or 1)
have had a sample of cancer tissue (biopsy ) taken that shows your cancer has the PD-L1 protein
are willing to use contraception during treatment and for up to 5 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 neuroendocrine, clear cell or sarcoma cervical cancer
have cancer spread to the spinal cord or brain
have spinal cord compression unless it has been treated and has not got worse within the week before randomisation
have had another cancer in the past 5 years apart from successfully treated non melanoma skin cancer , early cancer of the womb (uterine) or DCIS
have had an immunotherapy drug

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

have liver disease such as hepatitis, cirrhosis or damage caused by alcohol
have an autoimmune disease or any other disease that affects your immune system causing immune deficiency . You might be able to take part if you have hypothyroidism, diabetes type 1 or skin problems. Your doctor can tell you more.
have an infection such as HIV or tuberculosis (TB) or you have had other infections such as Epstein Barres (EBV)
have had heart disease such as a heart attack in the 3 months before randomisation
have major surgery within 28 days of randomisation or might need surgery during the trial
have had a bone marrow transplant from a donor (allogeneic transplant) or have had a solid organ transplant
have had treatment that affects the immune system within the 4 weeks before randomisation
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:

are allergic to tiragolumab, atezolizumab or what they are made of or from
have a live vaccine within the 4 weeks before randomisation
are pregnant or breastfeeding

Trial design

This is an international phase 2 trial. The team need 160 women worldwide to take part with 12 women from the UK.

It is a randomised trial. You go into 1 of 2 treatment groups. Neither you nor your doctor chooses which group you go into. The 2 groups are:

atezolizumab and tiragolumab
atezolizumab on its own

Out of every 3 women who join, 2 go into the atezolizumab and tiragolumab group.

Diagram 1

You have atezolizumab and tiragolumab as a drip into a vein. You have it every 3 weeks.

You have atezolizumab on its own as a drip into a vein. You have it every 3 weeks.

You continue with treatment as long as it is helping and the side effects aren’t too bad.

Research samples
You give blood samples and tissue samples (biopsies) before starting treatment and during treatment. Researchers use these to look for substances (biomarkers Open a glossary item ) that might tell them how well the treatment is working and to find out more about cervical cancer.

Hospital visits

You see the doctor to have tests before joining the trial. These tests include:

physical examination
blood tests
heart trace (ECG )
sample of cancer tissue (biopsy) if needed
CT scan
MRI scan
bone scan

During treatment you see the doctor every 3 weeks. This is for bloods and to see how you are doing.

You have a CT scan or MRI scan every 6 weeks for 48 weeks.

You see the doctor within a month of finishing treatment for blood tests. You then see them every 3 months until the study ends.

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

Atezolizumab and tiragolumab can affect the immune system. They may cause inflammation in different parts of the body which can cause serious side effects. This could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening.

If you have any of these side effects, you should tell the doctor or nurse as soon as possible that you are on or have been on an immunotherapy.

Tiragolumab is a new drug and there might be side effects we don’t know about yet. We do know that some people have a reaction while having tiragolumab. The symptoms can be:

fever
chills
shortness of breath
feeling sick
changes in blood pressure

Tell your nurse or doctor straight away if you have any of these symptoms when having tiragolumab. They will slow down or possibly stop the drip. Your doctor might prescribe some medication to have before your next tiragolumab to prevent or reduce these symptoms.

We have information about atezolizumab and its side effects.

Your doctor or a member of the trial team will talk to you about the side effects of atezolizumab and tiragolumab before you agree to join the trial.