RecruitingPHASE3INTERVENTIONAL

Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)

This study, called DESTINY-Ovarian01, is for women with advanced ovarian cancer that shows a specific marker called HER2. Researchers want to find out if adding a new medicine called Trastuzumab Deruxtecan to a standard treatment, Bevacizumab, helps keep the cancer from growing back after initial chemotherapy. They are comparing the combination of these two drugs to Bevacizumab on its own. The study is particularly looking at the safety and how well the treatment works as a 'maintenance therapy,' meaning it's given after the main treatment to try and prevent cancer recurrence. It’s an important step to see if this new approach could offer a better option for people with HER2-expressing ovarian cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Daiichi Sankyo

Enrolment target

582

Start

19 Mar 2025

Estimated completion

31 Jan 2032

Ovarian Cancer

What is this study about?

This study, called DESTINY-Ovarian01, is focusing on a type of advanced ovarian cancer where the cancer cells have a particular characteristic called HER2. HER2 is like a signal on the cancer cell's surface that can encourage it to grow. For some time, doctors have understood that treatments targeting HER2 can be helpful for other cancers, and now they are looking at how this might apply to ovarian cancer.

The main idea behind this research is to see if a new medicine called Trastuzumab Deruxtecan, when given together with an existing treatment called Bevacizumab, works better than Bevacizumab alone. Bevacizumab is a common treatment used to slow down cancer growth by cutting off its blood supply. Trastuzumab Deruxtecan is a newer type of drug designed to specifically target cancer cells that have the HER2 signal.

After initial chemotherapy, treatments like Bevacizumab are sometimes given to help keep the cancer under control. This is known as 'maintenance therapy.' Researchers want to find out if adding Trastuzumab Deruxtecan to this maintenance step can improve outcomes for women with HER2-expressing ovarian cancer. It's hoped that this combination could offer a more effective way to manage the disease long-term.

Key takeaways

New study for advanced HER2-expressing ovarian cancer.
Compares a new drug combination with an existing treatment.
Aims to improve maintenance therapy after initial chemotherapy.
Could offer a new treatment option for specific ovarian cancers.
Involves regular medical check-ups and treatments.

Who may be eligible?

This study is for adult women, aged 18 or over, who have been newly diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer. Your cancer needs to be a specific type (high-grade epithelial) and must show a certain amount of the HER2 marker. This HER2 marker helps doctors understand if the new drug might be right for you. They will check for this marker using a sample of your cancer tissue.

You also need to have recently completed up to six cycles of standard chemotherapy, which included Bevacizumab. Before joining, your doctors will also check specific genetic information about your cancer, such as BRCA or HRD status, as this can affect treatment choices. You will need to sign consent forms for the study and for genetic testing.

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.

Are you 18 years old or older?
Have you been diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer?
Does your cancer show the HER2 marker (you might need to ask your doctor for this test result)?
Have you recently completed regular chemotherapy that included Bevacizumab (up to 6 cycles)?
Are you willing to have tissue samples checked for HER2 and other genetic markers?

Answer every question to see your result.

What does participation involve?

If you join this study, it will begin with a short safety check phase for some participants to see how the new drug combination is tolerated. After that, you will be randomly assigned to receive either the combination of Trastuzumab Deruxtecan plus Bevacizumab, or Bevacizumab on its own. You will receive these treatments regularly, typically through an IV drip. You will have regular appointments for check-ups, blood tests, and scans to monitor your health and how the treatment is working. The exact number of visits and the full duration of your participation will be discussed in detail by the study team, but generally, maintenance treatments are given over an extended period. There will also be follow-up appointments after your treatment ends.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit from a new treatment that could be more effective than standard options, or you could help doctors learn more about ovarian cancer, which may help others in the future. However, new treatments can also have unexpected side effects or might not work as well as hoped. All medical treatments, including Bevacizumab, have known side effects. The study team will carefully explain the possible side effects of all treatments involved. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (193)

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

Scripps Clinic
Verified postcode
La Jolla, United States· Recruiting
Broward Health Medical Center
Verified postcode
Fort Lauderdale, United States· Recruiting
Jupiter Medical Center
Verified postcode
Jupiter, United States· Recruiting
Mount Sinai Medical Center
Verified postcode
Miami Beach, United States· Recruiting
AdventHealth Cancer Institute
Verified postcode
Orlando, United States· Recruiting
Woman's Care FL
Verified postcode
St. Petersburg, United States· Recruiting
Nancy N. & J.C Lewis Cancer & Research Pavillion- St. Josephs/ Candler Health System
Verified postcode
Savannah, United States· Recruiting
Endeavor Health Evanston Kellogg Cancer Care Center
Verified postcode
Evanston, United States· Recruiting
Indiana University
Verified postcode
Indianapolis, United States· Recruiting
Trials365 LLC
Verified postcode
Shreveport, United States· Recruiting
Greater Baltimore Medical Center
Verified postcode
Towson, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting

Common questions

What is HER2-expressing ovarian cancer?

HER2-expressing ovarian cancer means your cancer cells have a protein called HER2 on their surface. This protein can make cancer grow and knowing it's there helps doctors choose specific treatments.

What is 'maintenance therapy'?

Maintenance therapy is treatment given after initial chemotherapy has shrunk or controlled the cancer. It's meant to keep the cancer from growing back or progressing for as long as possible.

What are Trastuzumab Deruxtecan and Bevacizumab?

Trastuzumab Deruxtecan is a new 'targeted' drug that specifically attacks cancer cells with the HER2 protein. Bevacizumab is a drug that works by cutting off the blood supply to cancer cells.

Will I know which treatment I'm getting?

After an initial safety check phase for some, you will be randomly assigned to one of the treatment groups, meaning you might get the new combination or Bevacizumab alone. Often, in studies like this, you may not know which one you are receiving.

What does a 'Phase 3' study mean?

A Phase 3 study is a large, advanced stage of research. It means the treatment has already been tested in smaller groups and now researchers are comparing it to existing standard treatments to see if it's better or safer.

How to find out more

Contact for Trial Information

ctrinfo_us@daiichisankyo.com 908-992-6400 Official trial record

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