Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1/2 Study of Relatlimab (anti-LAG-3 Monoclonal Antibody) Administered in Combination with Both Nivolumab (anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 inhibitor) or in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

This important study is testing new drug combinations for people with advanced cancers. It brings together several medications, including a new one called Relatlimab, along with existing treatments like Nivolumab and others. The main goal is to understand if these combinations are safe and what side effects they might cause. Researchers will also be looking to see if these treatments can help shrink tumours or stop them from growing. This is an early-stage study, meaning it's one of the first times these specific combinations are being tested in people. The information gathered will help doctors decide if these treatments could be useful for future patients.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Bristol Myers Squibb International Corporation

Enrolment target

130

Start

19 Mar 2024

Advanced Malignant Tumors

What is this study about?

This study is investigating new treatment options for people who have advanced cancers. Advanced cancer means the cancer may have grown or spread in the body. Doctors are exploring different combinations of special medications to see if they can help tackle these cancers more effectively.

The medications being tested work in different ways to help the body's immune system fight cancer. For example, some drugs like Nivolumab and Ipilimumab are already used to boost the immune system. This study is testing a new drug called Relatlimab alongside these, and also exploring another combination that includes a drug called Linrodostat Mesylate. The idea is that using these drugs together might provide a stronger attack against cancer cells.

This is a 'Phase 1/2' study. This means it's an early step in testing new treatments. In Phase 1, the main focus is on safety – checking for side effects and finding the best dose. In Phase 2, if the treatment seems safe, researchers look more closely at how well it works against the cancer. The information from this study will be crucial in deciding if these combinations could become standard treatments in the future.

Key takeaways

This study is testing new drug combinations for advanced cancers.
It aims to find out if these combinations are safe and effective.
It involves several different immune-boosting medications.
It's an early-stage study (Phase 1/2).
You must be 18 or older to potentially participate.
Participation involves regular hospital visits for treatments and checks.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women are welcome to participate. The study is specifically for people who have advanced cancers.

There will be other detailed health checks to make sure the treatment is suitable and safe for you. For example, your doctors will review your general health, any other medical conditions you have, and any other medications you are currently taking.

It's important to discuss your full medical history with the study doctor to see if you meet all the criteria for this particular trial.

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 at least 18 years old?
Have you been diagnosed with an advanced cancer?
Are you generally well enough to participate in a clinical trial?
Are you prepared for regular hospital visits and medical tests?
Are you able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medications as infusions (drips into your vein) at the hospital. You'd have regular visits to the clinic for medical examinations, blood tests, and other checks to monitor your health and how you're responding to the treatment. These tests will help the doctors keep a close eye on any side effects and see how the medication is affecting your cancer. The total length of your participation would depend on how your cancer responds to the treatment and your general health, but you'd be given a clear schedule at the start. There would also be follow-up appointments after you stop taking the study medication to continue monitoring your health.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and potential risks. The potential benefit is that you might gain access to a new treatment that could help your cancer, which isn't yet widely available. However, there's no guarantee the treatment will work for you, and it might not be better than standard treatments. There are also potential risks, including experiencing side effects from the medications, some of which could be serious. It’s very important 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 (3)

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
France
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Unverified
Spain

Common questions

What does 'advanced malignant tumors' mean?

This refers to cancers that have grown or spread in the body. The study is looking for new ways to treat these types of cancers.

What are 'Phase 1' and 'Phase 2' studies?

Phase 1 studies primarily check if a new treatment is safe and help find the right dose. Phase 2 studies then look more closely at how well the treatment works.

Will I know which treatment combination I'm getting?

The study design will determine this. The doctors will explain whether you'll know your specific treatment or if it will be randomly assigned.

What kind of tests will I have during the study?

You'll have regular physical examinations, blood tests, and scans or other imaging tests to check your cancer and monitor your health.

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

Yes, you can choose to stop participating at any time, for any reason. Your decision won't affect your medical care.