RecruitingPHASE3INTERVENTIONAL

DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer

This study, called DESTINY-Endometrial01, is exploring new ways to treat advanced or recurrent endometrial cancer. Specifically, it's for patients whose cancer shows a particular marker called HER2 (either 3+ or 2+) and is 'mismatch repair proficient' (pMMR). Researchers are comparing combinations of new drugs like Trastuzumab Deruxtecan with Rilvegostomig or Pembrolizumab, against a standard chemotherapy treatment combined with Pembrolizumab. The main goal is to find out if these new combinations can help patients live longer without their cancer getting worse. It's a Phase 3 study, meaning these treatments have already shown some promise in earlier tests and are now being compared to existing treatments.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

600

Start

27 Mar 2025

Estimated completion

19 Feb 2031

Endometrial Cancer

What is this study about?

DESTINY-Endometrial01 is a research study looking for better ways to treat endometrial cancer that has either spread (advanced) or come back after initial treatment (recurrent). We know that not all endometrial cancers are the same. This study focuses on a specific type that has a protein called HER2 on the surface of its cells. You might hear this described as HER2-expressing, which means it shows up as 3+ or 2+ on a special test.

The study is comparing different combinations of medicines. One group of patients will receive Trastuzumab Deruxtecan with Rilvegostomig. Another group will get Trastuzumab Deruxtecan with Pembrolizumab. These are new drug combinations that researchers hope will be more effective. A third group will receive a common chemotherapy treatment (Carboplatin and Paclitaxel) along with Pembrolizumab, which is the current standard approach. The main thing researchers want to find out is whether the new drug combinations can stop the cancer from growing or spreading for longer than the standard treatment.

This kind of study is called a 'Phase 3' study. This means that the treatments have already been tested in a smaller number of people and have shown some positive effects. Now, they are being compared head-to-head with existing best treatments to confirm if they are truly better and safer before they can become widely available. The information gathered from this study will help doctors understand the most effective treatments for this specific type of endometrial cancer.

Key takeaways

This study is for advanced or recurrent endometrial cancer.
It focuses on cancer that has specific HER2 (3+/2+) and pMMR markers.
It compares new drug combinations against current standard chemotherapy plus immunotherapy.
The main aim is to see if new treatments can slow cancer growth for longer.
Participation involves regular clinic visits for treatment and monitoring.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. The study is specifically for women diagnosed with advanced endometrial cancer (meaning it's spread and is Stage III or IV) or if your endometrial cancer has come back after treatment. Your cancer needs to have a specific marker called HER2 (showing up as 3+ or 2+ on a test) and also be 'mismatch repair proficient' (pMMR), which are terms your doctor will understand from your test results.

You cannot have received treatment for your cancer that has already spread or come back. However, if you had chemotherapy or radiotherapy before for an earlier stage of cancer, you might still be eligible, especially if it was at least 6 months ago. You also can't have previously used certain types of treatments like antibody-drug conjugates or specific immunotherapy drugs.

Your medical team will need to provide samples of your tumor tissue to confirm these markers through central testing before you can join the study. This ensures the study is looking at the right group of patients for these specific treatments.

Quick self-check

Are you 18 years old or older?
Do you have advanced (Stage III/IV) or recurrent endometrial cancer?
Has your cancer been tested and found to be HER2 3+ or 2+?
Has your cancer also been tested and found to be 'mismatch repair proficient' (pMMR)?
Have you NOT had previous treatment for your advanced or recurrent cancer (except specific prior treatments like adjuvant chemotherapy that finished more than 6 months ago)?
Have you NEVER had certain types of antibody-drug conjugate or immunotherapy treatments before?

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

What does participation involve?

If you decide to participate in this study, you will be assigned to one of the treatment groups mentioned (either a new drug combination or standard chemotherapy with another drug). You'll receive your study medication at a clinic, and the frequency of these visits will depend on the specific treatment plan. You will have regular appointments where doctors will perform examinations, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. This is to ensure the treatment is working and to watch out for any side effects.

The study will continue for as long as the treatment is benefiting you or until unacceptable side effects occur. Even after stopping the study treatment, you will likely have follow-up visits or contact to track your health and long-term outcomes for a period of time. Your doctor or the study team will provide a detailed schedule of visits, tests, and medication administration if you are eligible and choose to take part.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. The potential benefit of joining this study is that you might receive a new treatment combination that could be more effective for your cancer than standard options, potentially slowing its growth or improving your quality of life. However, like all medications, the drugs used in this study can have side effects, which can range from mild to serious. These will be fully explained by the study team, and you will be closely monitored. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (250)

Research Site
Tucson, United States· Withdrawn
Research Site
Little Rock, United States· Recruiting
Research Site
Duarte, United States· Not yet recruiting
Research Site
Irvine, United States· Not yet recruiting
Research Site
La Jolla, United States· Recruiting
Research Site
Palo Alto, United States· Withdrawn
Research Site
San Francisco, United States· Suspended
Research Site
Sylmar, United States· Withdrawn
Research Site
Fort Myers, United States· Recruiting
Research Site
Miami Beach, United States· Recruiting
Research Site
Orlando, United States· Not yet recruiting
Research Site
St. Petersburg, United States· Recruiting

+238 more sites — see the official record for the full list.

Common questions

What is HER2-expressing endometrial cancer?

This means your cancer cells have a lot of a specific protein called HER2 on their surface, which can help the cancer grow. The study targets this specific type.

What does 'pMMR' mean?

pMMR stands for 'mismatch repair proficient'. This is a genetic feature of your cancer cells that helps doctors decide which treatments might work best for you.

Are the treatments in this study available outside the trial?

Some of the treatments might be standard, but the specific combinations for this type of endometrial cancer are currently being investigated and aren't widely available yet outside of studies.

What is the main goal of this study?

The main goal is to find out if the new drug combinations can keep endometrial cancer from growing or spreading for a longer time compared to standard treatment.

What happens after the study ends?

Even after you stop study treatment, the research team will likely continue to follow your health for some time to see the long-term effects of the treatments.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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