AuthorisedPhase II and Phase III (Integrated)Interventional

A Phase 2/3 randomized, open-label study of MK-1045 in combination with rituximab in patients with 1L follicular lymphoma.

This research study is investigating a new treatment approach for individuals who have been recently diagnosed with follicular lymphoma, a type of slow-growing cancer that affects the immune system. The study focuses on a new drug called MK-1045, given alongside rituximab, which is a common and established treatment for this condition. The main goals are to understand the safety of this new combination, including any side effects, and to see how well it helps control the cancer and improve patients' health. Researchers will also be looking at how the new drug behaves in the body and how it affects patients' quality of life. This is a large study, known as Phase 2/3, meaning it's moving from testing safety to looking more closely at effectiveness.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

09 Jun 2026

Follicular Lymphoma

What is this study about?

This study is about finding new and better ways to treat follicular lymphoma, a type of blood cancer that develops slowly. When people are first diagnosed with this cancer, they often receive standard treatments which are effective, but doctors are always looking for options that are even better, with fewer side effects, or that work for longer. This particular study is trying out a new medicine, MK-1045, in combination with a drug called rituximab, which is already a widely used treatment for follicular lymphoma.

The main idea behind this study is to see if adding MK-1045 to rituximab can make the treatment more effective than rituximab alone, or other standard combinations. Researchers will be carefully observing participants to understand if this new combination is safe, what side effects it might cause, and most importantly, how well it helps to stop the cancer from growing or even make it disappear. This is a combined Phase 2 and Phase 3 study. Phase 2 usually focuses on safety and whether the treatment shows promise, while Phase 3 involves more people and aims to confirm if the new treatment is truly better than existing ones.

They will be looking at several things, like whether the cancer shrinks or goes away completely, how long people stay free of cancer progression, and how this treatment affects their overall health and daily life. The study involves different standard chemotherapy drugs and other similar medicines as part of the overall treatment plan, allowing researchers to compare the new drug with what's currently available. This research could potentially lead to a new treatment option for people with follicular lymphoma.

Key takeaways

This study evaluates a new drug, MK-1045, for newly diagnosed follicular lymphoma.
MK-1045 is combined with rituximab, a standard treatment.
The study aims to check the safety and effectiveness of this new combination.
It's a combined Phase 2/3 study, moving from early safety checks to full effectiveness comparison.
Researchers will monitor how the treatment affects cancer and quality of life.

Who may be eligible?

To join this study, you would need to be at least 18 years old. There's no upper age limit, so people of many ages can be considered. Both men and women are welcome to take part.

Beyond age and sex, there will be other important health checks to make sure the study treatment is suitable and safe for you. This often includes looking at your overall health, any other medical conditions you have, and the specific details of your follicular lymphoma diagnosis. Detailed medical information will be reviewed by the study doctors to confirm if you meet all the necessary criteria.

It's important to remember that not everyone who wants to join a study will be eligible. The strict rules are there to protect participants and ensure the study results are clear and reliable. Your doctor will be able to tell you more about whether this study might be right for your personal situation.

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 newly diagnosed with follicular lymphoma?
Do you have good overall health, as assessed by a doctor?
Are you able to attend regular clinic visits and tests?
Are you willing to potentially receive a new, experimental drug?

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 medication, MK-1045, alongside rituximab and potentially other standard chemotherapy drugs such as cyclophosphamide, doxorubicin, prednisone, or vincristine, or bendamustine and prednisolone, depending on the specific group you are in. These medications are given in various ways, often through an infusion (drip) into your vein.

Your participation would involve regular visits to the study clinic. During these visits, the medical team would closely monitor your health, check for any side effects, and assess how the treatment is working. This would include physical examinations, blood tests, and possibly scans or other tests to track your cancer. You would also be asked to complete questionnaires to understand how your quality of life is affected.

The study is divided into two parts. Part 1 focuses on understanding the best dose and mainly on safety, while Part 2 looks more closely at how effective the treatment is over a longer period. The total duration of your participation, including follow-up appointments, would depend on the study's design and your individual response to treatment, but generally clinical trials involve treatment periods followed by monitoring for a number of years.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from receiving a new treatment that isn't yet widely available and that could potentially be more effective for your follicular lymphoma. You'll also receive close medical attention and monitoring throughout the study. However, there are potential risks, as the new drug MK-1045 could cause side effects that are not yet fully understood, or might be more severe than standard treatments. The existing drugs used in combination also have known side effects. The study team will explain all known side effects. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from 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 follicular lymphoma?

It's a type of slow-growing cancer that affects white blood cells called lymphocytes, which are part of your immune system. It often develops in lymph nodes but can be found elsewhere.

What is rituximab?

Rituximab is a common treatment for follicular lymphoma. It's an antibody that targets specific cells and helps your immune system fight the cancer.

What is MK-1045?

MK-1045 is a new drug being tested in this study. Researchers want to see if it can improve treatment outcomes when given with rituximab.

What do "Phase 2" and "Phase 3" mean?

Phase 2 studies test a new treatment for safety and if it shows promise. Phase 3 studies compare it to standard treatments to confirm if it's better and safe on a larger scale.

Will I know if I'm getting the new drug or a standard treatment?

This is an "open-label" study, which means both you and your study doctor will know which treatment you are receiving.