Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An open label phase II basket trial exploring the efficacy and safety of the combination of Niraparib and Dostarlimab in patients with DNA repair-deficient or platinum-sensitive solid tumors (NIRADO)

This study, called NIRADO, is looking into a new way to treat certain cancers using two medicines combined: JEMPERLI (given as an infusion) and Zejula (a tablet). The trial focuses on people whose cancer has specific changes in their DNA (DNA repair-deficient) or whose cancer has responded well to platinum-based chemotherapy in the past (platinum-sensitive solid tumors). Researchers want to find out how effective this combination is at shrinking tumors and how safe it is for patients. This is an early-stage study (Phase II), meaning these medicines are already known to be safe on their own, and now doctors want to see if using them together can be more helpful. The main goal is to measure how many patients' tumors shrink after about 15 weeks of treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Gustave Roussy

Enrolment target

112

Start

09 Jul 2024

DNA repair-deficient or platinum-sensitive solid tumors

What is this study about?

This study, known as NIRADO, is exploring a new treatment approach for specific types of solid cancers. Doctors are particularly interested in cancers that have certain genetic changes (called 'DNA repair-deficient') or those that have previously responded well to a common type of chemotherapy called 'platinum-based' treatment. The idea is to combine two different medicines, JEMPERLI and Zejula, to see if they can work better together than alone. JEMPERLI is given directly into a vein as an infusion, while Zejula is a tablet you take by mouth.

This is a 'Phase II' study. This means the medicines have already undergone initial testing and are known to be generally safe. Now, researchers are focusing on how well the combination works against cancer and identifying any side effects when used together. By combining these treatments, doctors hope to find a more effective way to shrink tumors and improve the health of people with these specific cancer types.

The main goal of this study is to measure the 'Overall Response Rate' after about 15 weeks of treatment. This means doctors will be carefully checking how many patients' tumors shrink or disappear. They will also look at other important things, like how long the treatment keeps the cancer from growing, how long people live, and how the treatment affects their quality of life. All of this information helps build a fuller picture of how helpful this new treatment combination might be.

Key takeaways

This study is testing a combination of two cancer medicines: JEMPERLI and Zejula.
It's for people with specific types of solid cancer, either with certain DNA changes or those sensitive to platinum chemotherapy.
The main aim is to see how well the combination shrinks tumors and if it's safe.
Participation involves regular clinic visits for treatment, tests, and monitoring.
You have the right to leave the study at any time.
It's a Phase II trial, looking for effectiveness and side effects of the combination.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women are welcome to take part. The study is specifically for people who have been diagnosed with certain types of solid cancer.

Your cancer needs to fit one of two categories: either it has specific changes in its DNA that affect how it repairs itself (this is called 'DNA repair-deficient'), or your cancer has shown a good response to previous treatment with chemotherapy medicines that contain platinum.

Your doctors will do some tests to see if your specific cancer matches these requirements and if other health factors make you a good fit for the study. There may be other criteria, like your general health, that your doctor will discuss with you.

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?
Do you have a solid cancer diagnosis?
Has your doctor identified your cancer as having specific DNA repair issues OR being sensitive to platinum chemotherapy?
Are you generally well enough to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive two medicines: JEMPERLI, administered as an infusion (like a drip into your arm), and Zejula, taken as tablets by mouth. You will have regular visits to the clinic for your infusions, to pick up your tablets, and for check-ups. During these visits, doctors will perform various assessments, such as physical exams, blood tests, and scans (like CT scans) to see how you are responding to the treatment and to monitor your general health.

The study will carefully track how your cancer responds, especially after about 15 weeks. You will continue to be monitored for side effects and how you are feeling. The exact total time you spend on the study will depend on how your cancer responds to the treatment and what your doctor advises, but there will be ongoing follow-up visits.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments before they are widely available, which might be beneficial if other options haven't worked for you. However, there are no guarantees, and the treatment might not be effective for everyone. As with all medicines, there's a risk of side effects, which doctors will discuss with you in detail, and they will closely monitor you throughout the study. Remember, joining a study is always your choice, and you have the right to withdraw at any time for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What does 'DNA repair-deficient' mean?

It means your cancer cells have specific problems in their ability to fix damaged DNA, which can sometimes make them more sensitive to certain treatments.

What are 'platinum-sensitive solid tumors'?

These are cancers that previously responded well to a type of chemotherapy medicine containing platinum, meaning the treatment helped shrink or control the cancer.

What is a 'Phase II' study?

It means the medicines have already been tested for safety, and now doctors are focusing on how effective they are at treating the specific cancer and identifying side effects when used together.

How does this treatment work?

This study is combining two medicines. JEMPERLI is an infusion, and Zejula is a tablet. They work in different ways to target cancer cells, and doctors want to see if using them together is more effective.

What does 'Overall Response Rate' mean?

It's a way doctors measure how many patients' tumors shrink or disappear after receiving the treatment in the study.