Active not recruitingPHASE3INTERVENTIONAL

Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line

This important study is investigating a new treatment option, dostarlimab, for women with advanced or recurrent endometrial cancer. Specifically, it's for cancers that have a particular genetic characteristic known as 'MMR deficient'. Researchers want to compare dostarlimab against the usual chemotherapy treatment (carboplatin-paclitaxel) to see if it's more effective and has fewer side effects. If you have been diagnosed with advanced or recurrent endometrial cancer and your doctor has mentioned your cancer is MMR deficient, this study might be relevant to you. It's a 'Phase 3' study, meaning it's a large-scale trial aiming to confirm the benefits of the new treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

ARCAGY/ GINECO GROUP

Enrolment target

260

Start

15 Apr 2022

Estimated completion

01 Oct 2029

Endometrial Cancer

What is this study about?

This study is looking into new ways to treat advanced or recurring endometrial cancer. Endometrial cancer starts in the lining of the womb. When we say 'advanced' or 'recurring', it means the cancer has spread beyond the womb or has come back after previous treatment.

The trial focuses on a specific type of endometrial cancer called 'MMR deficient'. This is a characteristic of the cancer cells that doctors can identify. For patients with this type of cancer, researchers want to see if a new medicine, called dostarlimab, works better than the standard chemotherapy drugs, carboplatin and paclitaxel. Dostarlimab is a type of immunotherapy, which helps your own immune system fight the cancer.

The main goal is to find out if dostarlimab is more effective at treating the cancer and if it has a different set of side effects compared to chemotherapy. By comparing these two treatments, doctors hope to find a better option for future patients. This is a common way new medicines are tested to make sure they are safe and helpful.

Key takeaways

This study compares a new drug (dostarlimab) with standard chemotherapy for specific endometrial cancers.
It's for advanced or recurring endometrial cancer that is 'MMR deficient'.
Participation is voluntary, and you can withdraw at any time.
You'll receive close medical monitoring if you join.
The aim is to find better treatment options for patients in the future.

Who may be eligible?

To join this study, you must be a woman aged 18 or older with endometrial cancer that has either come back or is advanced. Your cancer must also have a specific feature called 'MMR deficient'. Your doctor will be able to check for this.

Your general health needs to be good enough to take part, which doctors measure using a scale called ECOG (you'd need a score of 0 or 1). This just means you're generally able to look after yourself and do light activities. You also need to have cancer that doctors can measure, even if it's small.

The study is for patients whose cancer is either newly diagnosed as advanced/metastatic, or has returned. If you've had chemotherapy for your cancer before, you might still be able to join, but there are specific rules about how long ago it was. If you've had radiotherapy, that's usually okay too, as long as it was more than three weeks before starting the study.

Quick self-check

Are you a female aged 18 or older?
Do you have advanced or recurring endometrial cancer?
Has your doctor confirmed your cancer is 'MMR deficient'?
Is your general health good enough for you to look after yourself (ECOG 0 or 1)?
Have you discussed your eligibility with your doctor?

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

What does participation involve?

If you decide to take part, you would be assigned to one of two groups by chance, like flipping a coin, but your doctor won't choose which group you are in. One group will receive the standard chemotherapy (carboplatin-paclitaxel), and the other group will receive the new treatment, dostarlimab. You will have regular appointments with the study team for tests, scans, and to receive your treatment.

The study involves visits to the clinic for treatment and assessments of your health and how the treatment is working. This will include blood tests and scans. The exact number and frequency of visits will be explained by the study team. You will be closely monitored throughout the study, and for a period after your main treatment finishes, to check on your health and any long-term effects. The total duration of your participation will depend on your individual response to treatment and the study's follow-up plan, but it generally involves regular contact for a significant period.

Potential risks and benefits

Participating in a clinical trial may offer benefits, such as access to a new treatment like dostarlimab before it's widely available, and close medical monitoring. However, there are also potential risks; treatments can cause side effects, and the new treatment might not be more effective than standard care. You will be fully informed of all known side effects for both treatments before you decide to join. It's crucial to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (100)

Canberra Hospital
Garran, Australia
Calvary Mater Newcastle
Waratah, Australia
Princess Margaret Cancer Centre
Toronto, Canada
CHU d'Amiens - Hôpital Sud
Amiens, France
Clinique de l'Europe
Amiens, France
ICO Paul Papin
Angers, France
Centre Hospitalier d'Auxerre
Auxerre, France
Institut Sainte Catherine
Avignon, France
CH Simone Veil de Beauvais
Beauvais, France
CHRU Jean Minjoz
Besançon, France
Institut Bergonié
Bordeaux, France
CHU Brest
Brest, France

+88 more sites — see the official record for the full list.

Common questions

What does 'MMR deficient' mean?

It's a specific characteristic of the cancer cells. Your doctor can test for this, and if your cancer has it, you might be eligible for this study.

What is dostarlimab?

Dostarlimab is a new type of medicine called immunotherapy, which works by helping your body's immune system fight the cancer.

Will I definitely get the new drug if I join?

No, because this is a comparative study, you'll be randomly assigned to either receive dostarlimab or the standard chemotherapy treatment.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.

What is a 'Phase 3' study?

This means it's a large study, comparing a new treatment to existing ones, to see if the new treatment is better and safer before it becomes widely available.