What is the aim of the study?

This trial is investigating a new combination treatment for women with low-grade serous ovarian cancer that has returned after previous treatment. The aim is to determine whether this new treatment works better than current standard treatments. Current treatments for LGSOC, such as chemotherapy and hormone therapy, may not always be as effective as desired. For this reason, this study is looking at a new combination of investigational drugs, avutometinib and defactinib, to see if they are better at slowing or stopping cancer growth in patients with LGSOC. Both drugs are kinase inhibitors – drugs that target specific signaling pathways that cancer cells use to grow.

What is the survey procedure?

If the study is suitable for you and you decide to participate:

you will be randomly assigned to either the new combination treatment being studied or one of several standard treatments chosen by your doctor.

Group 1: You will receive avutometinib twice a week and defactinib twice a day in tablet form. These drugs are taken for three weeks, followed by a one-week break, which together form a cycle.

Group 2: Standard care for LGSOC. One of the currently available treatments, such as chemotherapy or hormone therapy, based on your doctor’s recommendation.

You will undergo regular examinations, scans and blood tests to monitor your health and your cancer. The length of your participation will depend on how your body responds to the treatment. You will continue to receive the study treatment for as long as it helps to control your cancer and you can tolerate any side effects.

If you are assigned to Group 2 and your cancer worsens during treatment, you may be eligible for cross-over to Group 1. Even after your treatment has ended, you will be followed up for up to 5 years to monitor your health.

Are there any risks?

The new treatment may cause side effects, some of which may be serious, e.g. skin reactions, digestive problems, eye problems.
The new treatment may not work as well as the standard treatments. You may be assigned to a standard treatment instead of the new treatment.

Participation requirements

The study could be suitable for you if you:

• are at least 18 years old
• have been diagnosed with recurrent low-grade serous ovarian cancer
• have measurable tumors on scans
• are physically fit enough to participate in a clinical trial
• are willing to undergo regular medical examinations, blood tests and other health assessments