Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator’s Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

This research study, called ARTISTRY-7, is for women with advanced ovarian, fallopian tube, or primary peritoneal cancer that has come back or grown despite previous platinum-based chemotherapy. Researchers want to find out if a new combination of treatments, nemvaleukin alfa with pembrolizumab (Keytruda), is better than standard chemotherapy options. This is a `Phase 3` study, which means it's one of the final steps before a new treatment might become widely available. Participants will be randomly assigned to receive either the new combination or one of several standard chemotherapy drugs. The main goal is to see if the new combination helps people live longer, and also to understand if it shrinks tumours, controls the cancer, and what side effects it might have.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Mural Oncology Inc.

Enrolment target

244

Start

04 Sep 2024

Platinum-Resistant Epithelial Ovarian Fallopian Tube or Primary Peritoneal Cancer

What is this study about?

This important study, named ARTISTRY-7, is looking for better ways to treat certain types of advanced cancers in women: ovarian, fallopian tube, and primary peritoneal cancer. These are cancers that start in the reproductive organs or the lining of the abdomen. Participants in this study have cancer that has unfortunately become resistant to a type of chemotherapy called 'platinum-based' treatment, meaning those treatments are no longer working.

The study aims to compare a new treatment approach, which combines two drugs called nemvaleukin alfa and pembrolizumab, against the chemotherapy treatments doctors currently use. Pembrolizumab, also known as Keytruda, is an existing immunotherapy drug. Nemvaleukin alfa is a newer drug that helps the immune system fight cancer. By comparing these, doctors hope to find out if the new combination can help people live longer and improve their quality of life.

This is a `Phase 3` study, which means it's a large, carefully designed trial. It's an open-label study, so both you and your doctor will know which treatment you are receiving. It's also 'randomized,' meaning a computer will decide which treatment group you are in, like flipping a coin. This helps make sure the results are fair and reliable. The main thing doctors want to measure is how long people live (called 'overall survival'). They will also look at how much the cancer shrinks or stops growing, and what side effects people experience.

Key takeaways

This study is for advanced ovarian, fallopian tube, or primary peritoneal cancer that is no longer responding to platinum-based chemotherapy.
It compares a new drug combination (nemvaleukin alfa + pembrolizumab) with standard chemotherapy.
The main aim is to see if the new treatment helps people live longer.
Participation involves regular hospital visits for treatment, tests, and monitoring.
You will know which treatment you are receiving (it is 'open-label').
You can stop participating at any time without affecting your normal care.

Who may be eligible?

To join this study, you must be a woman aged 18 or older. You will need to have been diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer. Importantly, your cancer must have proven resistant to platinum-based chemotherapy, meaning that type of treatment did not work or stopped working.

There will be other medical checks to make sure you are well enough to take part and that the study treatments are safe for you. For example, your general health, organ function (like your kidneys and liver), and other medical conditions will be carefully reviewed by the study team.

Your doctor will be able to review all your medical history and test results to confirm if you meet all the specific requirements to be part of this trial. It's crucial that any past treatments and your current health status fit the criteria set by the researchers.

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 a woman aged 18 or over?
Have you been diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer?
Has your cancer started to grow or returned after platinum-based chemotherapy?
Are you able to travel to regular hospital appointments for treatment and tests?
Are you generally well enough to undergo cancer treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through screening tests to make sure you're eligible. Once accepted, you'll be randomly assigned to one of two treatment groups: either the new combination of nemvaleukin alfa and pembrolizumab, or one of the standard chemotherapy treatments (such as doxorubicin, paclitaxel, gemcitabine, or topotecan). You and your doctor will know which treatment you are receiving.

Throughout the study, you'll have regular visits to the hospital for your treatment and various assessments. These will include blood tests, physical examinations, and scans (like CT scans) to see how the treatment is working and monitor for any side effects. You'll also have checks of your vital signs (like blood pressure and heart rate) and heart tracings (ECGs). These visits will continue as long as you are benefiting from the treatment and are tolerating it well. The study aims to follow participants for a period after treatment ends to track their health. The total duration of your participation will depend on how you respond to the treatment and the follow-up schedule.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving a new and potentially more effective treatment for your cancer, which might not yet be widely available. You will also have very close medical monitoring and care during the study. However, there are also potential risks. The new treatment might cause side effects that we don't fully know about yet, or it might not work for everyone. Standard chemotherapy also has known side effects, which the study team will discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

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

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Unverified
Italy
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Unverified
Norway
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Unverified
Spain
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Unverified
France
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Unverified
Denmark
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Unverified
Belgium
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Unverified
Austria
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Unverified
Germany
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Unverified
Czechia
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Unverified
Lithuania

Common questions

What is 'platinum-resistant' cancer?

It means your ovarian, fallopian tube, or peritoneal cancer has grown or returned even after you've had chemotherapy treatments that include drugs like platinum. This suggests those types of chemotherapy are no longer effectively controlling your cancer.

What is a `Phase 3` study?

A `Phase 3` study is a large research trial that compares a new treatment with an existing standard treatment. It's one of the last stages before a new treatment might be approved for general use, to confirm if it's safe and effective.

Will I know which treatment I'm getting?

Yes, in this study, both you and your doctor will know whether you are receiving the new combination treatment or one of the standard chemotherapy drugs.

What are the main goals of this study?

The main goals are to see if the new combination treatment helps people with platinum-resistant cancer live longer, shrinks their tumours, and what side effects it might cause.

Can I stop participating in the study at any time?

Yes, you can choose to leave the study at any point, and this will not affect your future medical care.