Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

CONGRATS : COMBINATION OF NIVOLUMAB PLUS RELATLIMAB IN PATIENTS WITH ADVANCED OR METASTATIC SOFT-TISSUE SARCOMA: A PROOF-OF-CONCEPT RANDOMIZED PHASE II STUDY

This study, called CONGRATS, is exploring new ways to treat advanced soft-tissue sarcoma in adults. It's a Phase II trial, meaning it's still in relatively early exploration. Researchers are testing two different treatment approaches: one group will receive a combination of two drugs, nivolumab and relatlimab, while another group will receive nivolumab on its own. The main goal is to see if these treatments can stop the cancer from getting worse for at least six months. Doctors will carefully monitor how patients respond to the treatment, looking for signs that the cancer has shrunk, stayed the same, or is growing. This information will help them understand if these drugs could be a promising future treatment option.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Bergonie

Enrolment target

Start

25 Sep 2024

Adult participants with advanced unresectable or metastatic soft-tissue sarcoma.

What is this study about?

This study, known as CONGRATS, is designed for adult patients who have soft-tissue sarcoma that has either spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). The main purpose of this research is to see how well two different types of treatment work. These treatments involve drugs called nivolumab and relatlimab.

Patients in this study will be split into two groups. One group will receive a combination of both nivolumab and relatlimab, while the other group will receive nivolumab on its own. The researchers want to find out if these treatments can keep the cancer from growing or spreading for at least six months. They will regularly check scans to see if the cancer has shrunk, stayed the same, or grown. This six-month progression-free rate is a really important measure to understand how effective the treatments are.

It's important to know that this is a 'Phase II' study. This means it's an early-stage trial trying to see if these treatments are promising enough to study further in larger groups of patients. While it won't directly compare the two treatment groups against each other, it will give valuable information on the potential benefit of each approach for people with advanced soft-tissue sarcoma.

Key takeaways

This study is for adults with advanced or metastatic soft-tissue sarcoma.
It tests two treatments: nivolumab plus relatlimab, or nivolumab alone.
The main goal is to see if treatments control cancer for at least six months.
It's an early-stage (Phase II) trial to find promising new options.
Regular scans and health checks are part of participating.

Who may be eligible?

This study is looking for adult patients, meaning you must be 18 years old or older to take part. Both men and women are welcome.

The main condition for joining is having advanced soft-tissue sarcoma. This means your cancer has either spread to other parts of your body or cannot be removed through surgery.

There will be other detailed medical checks to make sure the study treatments are safe for you and that you meet all the research requirements. These checks would be explained in full by the study team.

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 soft-tissue sarcoma?
Has your soft-tissue sarcoma spread (metastatic) or can it not be removed by surgery (unresectable)?
Are you able to travel for regular clinic visits and treatments?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive treatment with either nivolumab on its own or a combination of nivolumab and relatlimab, given through a drip (intravenous infusion). The study team will explain how often you would need to come for these treatments.

You would have regular appointments, likely including physical exams, blood tests, and scans (like CT or MRI scans) to monitor your health and how your cancer is responding. These checks are crucial for the researchers to understand the effects of the treatment. The cancer scans will be reviewed by expert doctors who don't know which treatment you are receiving.

The total length of your participation would depend on how you respond to the treatment and the study's design. There would also be a follow-up period after your treatment finishes to monitor your long-term health. The research team would go through a full schedule of visits and procedures with you.

Potential risks and benefits

Taking part in this study may offer a potential benefit by giving you access to new treatments that are not yet widely available. While these treatments are being tested for their effectiveness, there's no guarantee that they will work for everyone, and your cancer might not respond. As with all medications, there's a possibility of side effects, which the study team will explain in detail. You are always free to decide to leave the study 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 is soft-tissue sarcoma?

Soft-tissue sarcoma is a rare type of cancer that starts in tissues like muscle, fat, blood vessels, nerves, tendons, and lining of joints.

What do 'advanced' and 'metastatic' mean?

'Advanced' usually means the cancer is extensive or has returned. 'Metastatic' means the cancer has spread from where it started to other parts of the body.

What are nivolumab and relatlimab?

They are types of drugs called immunotherapy. They work by helping your body's own immune system fight cancer cells.

What is a 'Phase II' study?

A Phase II study is an early stage of clinical research that looks at whether a new treatment works and is safe in a small group of people with a specific condition.

Will I know which treatment I'm getting?

The study design can vary, but generally, for treatment studies, you would know you're in one of the active treatment groups, though sometimes which specific drug isn't revealed immediately.