All studies
RecruitingPHASE1, PHASE2INTERVENTIONAL

A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)

Researchers are investigating a new treatment, MK-1045, for people with two forms of non-Hodgkin lymphoma (NHL): follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). NHL is a cancer that affects lymph nodes, which are part of your body's immune system. FL is a slow-growing type, while DLBCL grows more quickly. MK-1045 is an investigational immunotherapy, meaning it's designed to help your own immune system fight the cancer. The main goals of this study are to understand how safe MK-1045 is, how well people tolerate it, and if it can make the lymphoma smaller or even go away.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
200
Start
03 May 2026
Estimated completion
01 Apr 2031

What is this study about?

Non-Hodgkin lymphoma (NHL) is a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system. This system helps your body fight off infections and diseases. In NHL, these white blood cells grow abnormally, often causing swollen lymph nodes. There are many different types of NHL. This study focuses on two specific kinds: follicular lymphoma (FL), which tends to grow slowly, and diffuse large B-cell lymphoma (DLBCL), which usually grows more quickly.

Doctors are always searching for better ways to treat these cancers. The treatment being studied here is called MK-1045. It's a type of immunotherapy, which means it works by boosting your body's own immune system to recognise and fight cancer cells. It's hoped that by making your immune system stronger, MK-1045 can help control or even shrink the lymphoma.

The main aim of this study is to find out if MK-1045 is safe for people to take and how well they tolerate it. The researchers will also be carefully watching to see if the treatment has a positive effect on the lymphoma. This means they will look to see if the cancer gets smaller or, ideally, disappears. By finding new and effective treatments, doctors hope to improve the outlook for people living with these challenging forms of non-Hodgkin lymphoma.

Key takeaways

  • The study is for people with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).
  • It's testing a new immunotherapy drug called MK-1045.
  • The main goals are to check the safety of MK-1045 and see if it shrinks the cancer.
  • Participants must be over 18 and have lymphoma that hasn't responded to previous treatments.
  • MK-1045 is an investigational treatment, meaning its full effects are still being learned.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have either follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).

To be considered, your lymphoma must have come back after or not responded to at least two previous treatments. If you have DLBCL, you would also need to have progressed after or not be suitable for a stem cell transplant or CAR-T cell therapy. Researchers will also need to review a sample of your tumour tissue. Certain other conditions, like poorly controlled HIV, Hepatitis B or C, or serious heart problems, would mean you couldn't take part. Also, if you've had an organ transplant or certain other serious health issues, you wouldn't be able to join this study.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL)?
  3. Has your lymphoma come back or not responded to at least two previous treatments?
  4. If you have DLBCL, have you progressed after or are you unsuitable for a stem cell transplant or CAR-T therapy?
  5. Do you have measurable cancer that can be seen on scans?
  6. Have you *not* had an organ transplant or certain serious heart or brain conditions?
Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not fully available in this brief summary. However, in a clinical trial like this, you would typically have regular visits to the hospital or clinic. These visits would include physical exams, blood tests, and scans (like CT scans) to monitor your health and how the treatment is working. You would receive the study medication, MK-1045, according to a specific schedule decided by the study doctors. There would also be follow-up appointments after your treatment ends to ensure your health is stable. The total duration of your participation would depend on the study's plan and your individual response.

Potential risks and benefits

Taking part in a clinical trial like this might offer a potential benefit of trying a new treatment (MK-1045) that might help your lymphoma when other treatments haven't worked or are not suitable. However, there are potential risks, as MK-1045 is an experimental drug, and its full side effects are not yet known. Like all medications, it could cause unwanted reactions. You would be closely monitored for any health changes. It's very important to remember that joining a clinical trial is a personal choice, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

  • Sanatorio Nuestra Senora del Rosario ( Site 1403)
    Verified postcode
    Rosario, Argentina· Recruiting
  • Beijing Cancer hospital ( Site 1701)
    Verified postcode
    Beijing, China· Recruiting
  • Shaare Zedek Medical Center ( Site 0603)
    Verified postcode
    Jerusalem, Israel· Recruiting
  • Haddasah Medical Center ( Site 0600)
    Verified postcode
    Jerusalem, Israel· Recruiting
  • Sheba Medical Center ( Site 0601)
    Verified postcode
    Ramat Gan, Israel· Recruiting
  • Sourasky Medical Center. ( Site 0604)
    Verified postcode
    Tel Aviv, Israel· Recruiting
  • Istituto di Candiolo - IRCCS ( Site 0701)
    Verified postcode
    Candiolo, Italy· Recruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 0900)
    Verified postcode
    Warsaw, Poland· Recruiting
  • Pratia Onkologia Katowice ( Site 0902)
    Verified postcode
    Katowice, Poland· Recruiting
  • Hospital Universitari Vall de Hebron ( Site 1102)
    Verified postcode
    Barcelona, Spain· Recruiting
  • Hospital Universitario Gregorio Maranon ( Site 1101)
    Verified postcode
    Madrid, Spain· Recruiting
  • Hospital Universitario 12 de Octubre ( Site 1105)
    Verified postcode
    Madrid, Spain· Recruiting

Common questions

What is non-Hodgkin lymphoma?

It's a type of cancer that starts in white blood cells in your immune system, often causing swollen lymph nodes.

What is MK-1045?

It's a study treatment that works as an immunotherapy, which means it helps your immune system fight cancer.

What are the main goals of this study?

The study aims to see how safe MK-1045 is, how people tolerate it, and if it can make the lymphoma shrink or go away.

Will I get this new treatment if I join?

If you are eligible and accepted into the study, you would receive the study treatment, MK-1045.

Can I stop participating in the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.

How to find out more

Toll Free Number

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Clinical Study of MK-1045 in People With Non-Hodgkin Lymph…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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