CompletedPhase IInterventional

A study evaluating the interaction of the body with (pharmacokinetics), clinical activity, and safety of RO6870810 and atezolizumab (PD-L1 Antibody) in participants with advanced ovarian cancer or triple-negative breast cancer

This early-stage study tests a new combination of two cancer medicines: an experimental drug named RO6870810 and an immunotherapy called atezolizumab. The main goal is to find the safest dose and see how the body handles the treatments when they are given together. Researchers also want to find out if the combination can help slow or shrink tumours in adults with advanced ovarian cancer or triple-negative breast cancer. People with these conditions often need new treatment choices if standard therapies have stopped working. Atezolizumab helps the body's natural immune defences recognise and attack cancer cells, and doctors hope RO6870810 will boost this effect. Participants receive RO6870810 as an injection under the skin for two weeks out of every three-week cycle, and atezolizumab as an intravenous drip once every three weeks, for up to 22 months.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Genentech, Inc

Enrolment target

Start

08 Nov 2017

Estimated completion

18 Dec 2018

Advanced ovarian cancer, triple negative breast cancer

What is this study about?

Advanced ovarian cancer and triple-negative breast cancer can be difficult to treat, especially when standard therapies such as chemotherapy are no longer working well. Researchers are working to find new, targeted treatments that can give people more options and improve their quality of life. This trial focuses on testing an experimental medicine, RO6870810, combined with an established immunotherapy called atezolizumab.

Immunotherapy works differently from traditional cancer drugs. Instead of attacking cancer cells directly, drugs like atezolizumab help your own immune system spot and fight the disease. Previous research suggests atezolizumab may help people with advanced breast and ovarian cancers. Early lab work also shows that adding RO6870810 might make the immune response even stronger, helping the treatment work better.

Because this is an early-phase trial, the primary focus is finding the right, safest dose of RO6870810 to use with atezolizumab. Doctors also track how the medicines move through the body and monitor any side effects closely. While early studies can offer hope, they are primarily designed to gather essential safety information to guide future treatments.

Key takeaways

Tests a new combination of two drugs: RO6870810 and the immunotherapy atezolizumab.
Aimed at adults with advanced ovarian cancer or triple-negative breast cancer.
The main goals are to find a safe dose, monitor side effects, and check tumour response.
RO6870810 is given as a daily skin injection for two weeks out of three; atezolizumab is given by drip every three weeks.
Participation lasts up to 22 months with regular hospital checks and scans.

Who may be eligible?

This trial is for adults diagnosed with advanced ovarian cancer or triple-negative breast cancer. To take part, participants must have tumours that can be measured on hospital scans and be well enough to carry out everyday activities, such as light housework or desk work.

Depending on the specific group in the study, participants may need to have already tried certain previous treatments, such as standard chemotherapy or specific immunotherapy drugs. If you have had immunotherapy before, a set amount of time must have passed, and any serious side effects from those earlier treatments must have fully settled.

Because the study drugs could harm an unborn baby, all participants who could become pregnant or father a child must agree to use reliable forms of contraception. The medical team will check your overall health and medical history to confirm if this trial is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have been diagnosed with advanced ovarian cancer or triple-negative breast cancer.
My cancer can be measured on hospital scans (such as a CT or MRI scan).
I am well enough to carry out light daily activities independently.
My previous cancer treatments have ended and any past side effects have cleared.
I am willing to attend regular hospital appointments, have scans, and provide biopsy samples.
I agree to use effective contraception throughout the study if applicable.

Answer every question to see your result.

What does participation involve?

Taking part in this study involves following a regular schedule of visits and treatments organised into three-week cycles. During each cycle, you receive RO6870810 as an injection under the skin once a day for the first 14 days, followed by a week off. Atezolizumab is given through a drip directly into a vein once on the first day of every cycle. Treatment can continue for up to 22 months, provided the medicines are helping and side effects remain manageable.

Throughout the study, you will have regular clinic visits. These appointments include blood tests, physical examinations, and body scans to check how your tumour is responding. You will also be asked to provide small tissue samples (biopsies) from your tumour so scientists can study how the drugs are working at a cellular level. You will be monitored closely by a specialist hospital team throughout the trial.

Potential risks and benefits

The possible benefit of joining this study is that the combination of drugs may help shrink or stabilise your cancer, although this cannot be guaranteed. However, all cancer treatments carry risks. Common side effects reported with these medicines include tiredness, reduced appetite, nausea, vomiting, diarrhoea, constipation, and a mild cough. Blood tests may also show temporary drops in red blood cells (anaemia) or platelets. The clinical team has careful plans in place to manage side effects, and you can choose to leave the study at any time without giving a reason and without your normal medical care being affected.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Christie NHS Foundation Trust
Unverified
Manchester, England
Western General Hospital
Unverified
Edinburgh, Scotland
Churchill Hospital
Unverified
Oxford, England
Guy's and St Thomas' NHS Foundation Trust
Unverified
London, England
Dana Farber Cancer Institute
Unverified
Boston, United States of America
Peter MacCallum Cancer Centre
Unverified
Melbourne, Australia
St Vincent's Hospital
Unverified
Sydney, Australia
Rigshospitalet
Unverified
Copenhagen, Denmark

Common questions

What is triple-negative breast cancer?

Triple-negative breast cancer is a type of breast cancer that does not have receptors for oestrogen, progesterone, or HER2 protein. This means common hormone therapies do not work on it, so new treatments are needed.

How is the treatment given?

One drug (RO6870810) is given as a daily injection under the skin for two weeks of each three-week cycle. The other drug (atezolizumab) is given as a drip into a vein once every three weeks.

Will I have to stay overnight in the hospital?

Most visits are completed as outpatient appointments during the day, though you may need to stay longer on days when detailed blood tests or scans are performed.

Do I have to have a tumour biopsy?

Yes, providing a tumour sample is a required part of this study so researchers can understand how the medicines affect the tumour.

Can I leave the study early if I change my mind?

Yes. Participation is entirely voluntary, and you can stop taking part at any point. Your doctors will continue to look after you and discuss other treatment options.

How to find out more

Clinical Trials

global-roche-genentech-trials@gene.com +1 888-662-6728 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.