Active not recruitingPHASE2INTERVENTIONAL

ATr Inhibitor in Combination With Olaparib/Durvalumab (MEDI4736) in Gynaecological Cancers With ARId1A Loss or no Loss

This study, called ATARI, is for women with gynaecological cancers that have returned after initial treatment. It's investigating new ways to fight these cancers. The main drug being tested is ceralasertib, which works in a specific way to stop cancer growth. Depending on the type of cancer and whether a gene called ARID1A is working normally or not, women will receive ceralasertib either on its own, or combined with one of two other drugs: olaparib or durvalumab. Olaparib is another cancer drug, and durvalumab is an immunotherapy, which helps your body's immune system fight the cancer. Researchers want to see how these combinations work in different groups of patients, hoping to find more effective treatments.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

174

Start

27 Nov 2019

Estimated completion

01 Aug 2026

Gynaecological Cancers

What is this study about?

This study, known as ATARI, is exploring new treatment options for women whose gynaecological cancers have come back after previous treatments. Gynaecological cancers affect a woman's reproductive organs, such as the ovaries or uterus. The main focus of this research is a drug called ceralasertib, which works to interfere with how cancer cells repair their DNA, making them more vulnerable. Researchers are trying to understand if giving ceralasertib by itself, or combined with other specific medicines, can be more effective.

In this study, ceralasertib is being tested alongside two other drugs. One is olaparib, which is another type of cancer drug also involved in DNA repair pathways. The other is durvalumab, which is an immunotherapy. Immunotherapy helps your own immune system recognise and attack cancer cells. The doctors leading this study believe that combining these drugs might offer a stronger punch against cancer than using one alone.

What makes this study particularly interesting is how patients are grouped. Researchers are dividing women based on their specific cancer cell type and whether they have a change (or 'loss') in a gene called ARID1A. This gene helps control cell growth, and changes in it are often seen in certain cancers. By looking at these specific groups, scientists hope to find out which drug combinations work best for which patients, leading to more personalised and effective treatments in the future.

Key takeaways

Aims to find new ways to treat gynaecological cancers that have returned.
Tests drugs like ceralasertib, olaparib, and durvalumab.
Focuses on how treatments work in different cancer types and with specific gene changes (ARID1A).
May offer access to new treatments not yet widely available.
Participation involves regular checks and potentially new medications.

Who may be eligible?

This study is looking for women aged 18 or older who have been diagnosed with certain types of gynaecological cancers that have returned after earlier treatments. This includes specific types of ovarian, uterine (endometrial), and cervical cancers, as well as some rarer forms like carcinosarcoma. Importantly, your cancer must have shown signs of growth since your last treatment. Also, you must have previously received at least one course of platinum-based chemotherapy.

For some parts of the study, if your cancer returned quickly after your last platinum-based treatment (within 6 months), you can't have had more than two other treatments since then. If you're being considered for groups using durvalumab, you must have also received a specific type of immunotherapy treatment before, like anti-PD-1, anti-PD-L1, or anti-CTLA-4, for at least six weeks. It's crucial that any past side effects from these previous treatments have completely cleared up before you can join.

Quick self-check

Are you 18 years old or older?
Do you have a gynaecological cancer that has returned?
Have you previously had platinum-based chemotherapy?
Is your cancer one of the specific types listed (e.g., clear cell, endometrioid, cervical, carcinosarcoma)?
Are any previous immunotherapy side effects completely cleared up (if applicable to your cancer type)?
Are you able to provide a tissue sample of your cancer?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve receiving one of the study drug combinations, either ceralasertib alone, ceralasertib with olaparib, or ceralasertib with durvalumab. You might have regular visits to the hospital for checks, blood tests, and scans to see how you're responding to the treatment. You will also need to provide a sample of your cancer tissue (from a biopsy you may have already had, or potentially a new one if needed) so the researchers can look at your ARID1A gene status. The exact number of visits, tests, and the total length of your participation would depend on which treatment group you are in and how you respond, but the team will explain all this clearly before you decide to join.

Potential risks and benefits

Participating in this study might offer a chance to try new treatments that are not yet widely available, which could potentially help control your cancer. However, as with all medications, there's a possibility of side effects from the study drugs. These will be carefully explained to you by the medical team. There is also no guarantee that the treatment will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

The Ottawa Hospital Cancer Centre
Ottawa, Canada
Princess Margaret Cancer Centre
Toronto, Canada
University of Montreal Hospital Centre
Montreal, Canada
Royal United Hospital
Bath, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
The Beatson
Glasgow, United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom
Imperial College NHS Trust
London, United Kingdom
The Christie
Manchester, United Kingdom

Common questions

What are gynaecological cancers?

These are cancers that affect a woman's reproductive system, such as ovarian, uterine (womb), and cervical (neck of the womb) cancers.

What does 'ARID1A loss' mean?

ARID1A is a gene in your cells. 'Loss' means this gene isn't working properly, which can affect how cancer cells grow. The study looks at whether treatments work differently depending on this gene.

Are these drugs (like ceralasertib, olaparib, durvalumab) new?

Ceralasertib is a newer drug being tested. Olaparib and durvalumab are also cancer treatments, but how they work in combination in this specific study is new research.

What does a 'Phase 2' trial mean?

A Phase 2 trial means the drugs have already been tested for safety in a smaller group (Phase 1) and now researchers are looking more closely at how well they work and for which patients.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your medical team will know which specific treatment combination you are receiving.