A trial of RO6874281 and atezolizumab for solid cancers (BP40234 Part 3)

Cancer type:

Cervical cancer
Head and neck cancers
Laryngeal cancer
Mouth (oral) cancer
Nasal and paranasal sinus cancer
Oesophageal cancer
Pharyngeal cancer
Salivary gland cancer
Secondary cancers

Status:

Open

Phase:

Phase 2
This trial is for people with a solid cancer that has come back after treatment, got worse during treatment or has spread to another part of the body.
 
A solid cancer Open a glossary item is any cancer apart from leukaemia Open a glossary item and lymphoma Open a glossary item. This trial is open to people who have:

More about this trial

There are 3 parts to this trial. Parts 1 and 2 are now closed. This summary is about part 3 of the trial. 
 
Atezolizumab is a targeted drug called an immunotherapy. It works by blocking a protein that stops the immune system Open a glossary item from working properly. 
 
RO6874281 is also an immunotherapy. It works by stimulating the immune system to kill cancer cells. 
 
Researchers think that the combination of atezolizumab and RO6874281 might be better than giving them separately. 
 
Everyone in the trial will have both atezolizumab and RO6874281. 
 
The aims of this trial are to find out:
  • how well this combination works 
  • about the side effects of this combination 

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 you have one of the following cancers:
  • cervical cancer
  • oesophageal cancer
  • a head and neck cancer  
And all of the following apply. You:
  • have a cancer that is a squamous cell carcinoma Open a glossary item 
  • have cancer that has spread to another part of the body (metastatic) or came back after treatment or got worse during treatment
  • have an area of cancer that doctors can measure on a scan 
  • are willing to have a small sample of tissue (biopsy Open a glossary item) taken from an area of cancer when you agree to join the trial and during the trial
  • have satisfactory blood test results
  • are fully active but not able to do heavy physical work (WHO performance status 0 and 1 or Karnofsky performance status 70 or greater)
  • are willing to use reliable contraception for up to 5 months after treatment if either you or your partner could become pregnant
  • are at least 18 years old
Who can’t take part
 
You cannot join this trial if any of these apply. 
 
Cancer related
You:
  • have cancer spread to the brain or spinal cord 
  • have an area of cancer pressing on your spine (spinal cord compression Open a glossary item) unless it has been successfully treated and it has been stable for 2 or more weeks before agreeing to join the trial
  • have another cancer apart from non melanoma skin cancer Open a glossary item, in situ carcinoma Open a glossary item of the cervix, prostate cancer that has been successfully treated with hormone therapy and there hasn’t been a sign of it for more than 2 years or any other cancer that was successfully treated with the aim to cure
  • have ongoing side effects or complications of previous anti cancer treatment apart from hair loss and mild nerve damage (peripheral neuropathy Open a glossary item)
 
Medical conditions
You cannot join this trial if any of these apply. 
You:
  • have had a heart attack, unstable angina, congestive heart failure or any other major heart problem in the past 6 months
  • have had a stroke or blood clot in the past 6 months
  • have high blood pressure that isn’t controlled by medication
  • have an active infection that needs to be treated or have a severe infection within 4 weeks of starting treatment
  • have HIV
  • have hepatitis B, hepatitis C, cirrhosis or any other long term (chronic) liver disease
  • have or might have an autoimmune disease Open a glossary item apart from an under active thyroid gland (hypothyroidism Open a glossary item) and you are on a stable dose of hormone replacement or you have type 1 diabetes and are taking a stable dose of insulin
  • have lung problems such as inflammation of the lung (pneumonitis) or pulmonary fibrosis
  • have fluid on both lungs (bilateral pleural effusion)  
  • are taking medication that affects how your immune system Open a glossary item works
  • have had radiotherapy within 4 weeks of starting treatment unless it was in a small area for symptom relief such as pain relief (palliative radiotherapy)
  • have major surgery or injury within 28 days of starting treatment or you might need to have surgery during the trial 
  • are having treatment with another experimental drug as part of another clinical trial
  • are very short of breath when resting and need to have oxygen
Other
You cannot join this trial if any of these apply. 
You:
  • have a live vaccine Open a glossary item within 4 weeks of starting treatment
  • are allergic or sensitive to RO6874281, atezolizumab or any of their ingredients
  • are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The team need 160 people to join. Everyone will have RO6874281 and atezolizumab. 
 
You have atezolizumab as a drip into a vein. The 1st treatment takes an hour. You are then monitored for 2 hours before having RO6874281. 
 
You have RO6874281 as a drip into a vein. The 1st treatment takes 2 hours. 
 
There are different groups in the study. How often you have treatment depends on which group you are in.  
 
In one group you have RO6874281 and atezolizumab on the same day every 3 weeks. Each 3 week period is a cycle of treatment.
 
In the other group you have RO6874281 every week and atezolizumab every other week for 4 weeks. From week 5 you have both on the same day every 2 weeks. Each 2 week period is a cycle of treatment. 
 
You continue to have treatment as long as your doctor thinks it is in your best interest and the side effects aren’t too bad. 
 
If for any reason you need to stop having RO6874281 or atezolizumab you might be able to continue having the one treatment by itself. You doctor will talk to you about this if it happens.  
 
Samples
The study team will take blood samples during the study. They will also take a small sample of cancer tissue (biopsy) at different times during the study.
 
They will use these samples to:
  • find out what happens to RO6874281 and atezolizumab in the body
  • look for substances (biomarkers Open a glossary item) that might tell them if the treatment is working
  • measure the amount of RO6784281 and atezolizumab in your blood
  • find out if your body has developed antibodies Open a glossary item to the treatment
  • find out more about your type of cancer

Hospital visits

You see the doctor to have some tests before starting treatment. These tests include:
  • a physical examination
  • blood tests 
  • urine test
  • heart trace (ECG Open a glossary item)
  • breathing test (lung function tests Open a glossary item)
  • MRI scan or CT scan
  • heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • chest x-ray
You see the doctor regularly during treatment for blood tests and to see how you are. You have CT scans or MRI scans every 8 weeks.
 
At the end of treatment and 4 weeks later you see the doctor for:
  • a physical examination
  • blood tests 
  • urine test
  • heart trace (ECG)
  • heart scan 
You then see the doctor every 3 to 4 months for:
  • a physical examination
  • blood tests
  • urine test
You have a CT scan or MRI scan every 8 weeks for the first year and then every 12 weeks. 

Side effects

Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:
  • you have severe side effects 
  • your side effects aren’t getting any better
  • your side effects are getting worse
You might have a reaction when you have RO6874281 or atezolizumab. It can happen during, soon after or within 24 hours of having treatment. It usually happens when you first have them. Some of the symptoms can include:
  • a high temperature (fever), shivering or chills
  • feeling or being sick
  • high or low blood pressure
  • changes to your heart beat
  • breathing difficulties
You have medication before starting treatment to prevent a reaction. You are monitored closely during and for a while after treatment. 
 
Tell your nurse if you have any of the above symptoms during treatment. After treatment contact your healthcare advice line if you have any of the above. 
 
RO6872481 is a new drug and there might be side effects we don’t know about yet. The side effects reported so far include:
  • high temperature (fever)
  • capillary leak syndrome – if you feel faint, sick and have swollen ankles or legs contact your doctor or the health care advice line straight away
  • changes to the way the heart works
We have information about the side effects of atezolizumab
 
These treatments affect the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. In some people, these side effects could be life threatening.
 
Your doctor or a member of the trial team will talk to you about the possible side effects of RO6874281 and atezolizumab before you agree to take part.

Location

London
Manchester

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 Colin Lindsay 

Supported by

F. Hoffmann-La Roche Ltd

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16201

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

Cara took part in a clinical trial

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"I am glad that taking part in a trial might help others on their own cancer journey.”

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