All studies
Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Coformulated With Berahyaluronidase Alfa (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)(MK-3475A-F65)

This study is testing a new way to deliver a medicine called pembrolizumab for adults with Hodgkin lymphoma or primary mediastinal large B-cell lymphoma that has come back or hasn't responded well to previous treatments. Currently, pembrolizumab is usually given into a vein (IV). In this study, it's mixed with another substance, berahyaluronidase alfa, and given as an injection just under the skin. We want to see how the body handles this new injection method and how effective it is at treating the lymphoma. This is a Phase 2 study, which means we're checking its safety and how well it works in a smaller group of people after initial safety tests.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
66
Start
14 Oct 2024
Estimated completion
08 Nov 2028

What is this study about?

This study is looking at a new version of a well-known medicine called pembrolizumab, which is used to treat certain types of cancer, including lymphoma. Normally, pembrolizumab is given into a vein, like a drip. However, this study is exploring a new way of giving it: as an injection just under the skin, similar to how some diabetes medications or vaccines are given. This new injection combines pembrolizumab with another substance called berahyaluronidase alfa, which helps the medicine spread easily once it's injected.

The main goal is to see how the body handles this new injection method and to find out how effective it is in treating people who have Hodgkin lymphoma or primary mediastinal large B-cell lymphoma that has either returned after treatment or hasn't responded well to previous therapies. By giving the medicine as an injection under the skin, it could potentially make treatments easier and quicker for patients, as they might not need to spend as much time in a clinic for an IV drip.

This is called a Phase 2 study. This means we're past the very first stages of testing and are now focusing on whether the treatment is safe and effective in a larger group of patients. We're carefully monitoring participants to understand the potential benefits and any side effects of this new way of delivering the medicine.

Key takeaways

  • This study tests a new injection form of pembrolizumab for specific lymphomas.
  • It aims to make treatment easier by giving it under the skin.
  • The study is for adults whose lymphoma has come back or not responded to treatment.
  • It's a Phase 2 study, focusing on safety and how well it works.
  • Participation involves regular clinic visits for injections and monitoring.

Who may be eligible?

To join this study, people generally need to have a confirmed diagnosis of classical Hodgkin lymphoma or primary mediastinal large B-cell lymphoma that has either come back or not responded well to past treatments. Your doctor would need to be able to measure your lymphoma on scans. You should also be generally well enough to take part, with a life expectancy of more than three months, and your doctor will check your overall health and how active you are, usually rated on a scale of 0 to 1.

There are also some specific health checks. For example, if you have HIV, it needs to be well-managed with your usual medication. If you've had hepatitis B or C, it needs to be under control. However, if you have certain heart conditions, active spread of another cancer, or a weakened immune system, you might not be able to join. Also, if you've recently had other antibody treatments or treatments that target similar pathways as pembrolizumab, you would likely not be eligible.

This study is for adults aged 18 and over, and it's open to both men and women.

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. Do you have classical Hodgkin lymphoma or primary mediastinal large B-cell lymphoma?
  2. Has your lymphoma come back or not responded to past treatments?
  3. Are you 18 years old or older?
  4. Are you generally well and active enough for daily life?
  5. Have you discussed your other health conditions (like heart problems, HIV, or hepatitis) with your doctor?
  6. Have you recently received certain other antibody cancer treatments?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study medication, which is a combination of pembrolizumab and berahyaluronidase alfa, given as an injection under your skin. You'll have regular hospital visits for these injections, check-ups, blood tests, and scans to monitor your lymphoma and how you're responding to the treatment. These visits will help the study doctors understand how the medicine is working and check for any side effects.

The exact number and timing of visits will be explained by the study team, but typically, there will be frequent visits initially, becoming less regular over time if the treatment is working well. You'll also have follow-up appointments after your treatment period ends to continue monitoring your health. The total duration of your involvement, including treatment and follow-up, will be made clear before you agree to take part.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is that this new way of giving pembrolizumab might be an effective treatment for your lymphoma, and it could be a more convenient option than current IV treatments. However, there's no guarantee the treatment will work for everyone, and it might not improve your condition. Potential risks include side effects from the medication, which will be carefully explained to you by the study team. These can vary, and some might be serious. It’s important to remember that participating in this study is completely voluntary, and you can withdraw at any time, for any reason, without it affecting your future medical care.

Locations (29)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Iowa-Holden Comprehensive Cancer Center ( Site 0115)
    Verified postcode
    Iowa City, United States
  • University of Iowa - Waukee ( Site 0111)
    Verified postcode
    Waukee, United States
  • Comprehensive Cancer Centers of Nevada ( Site 0114)
    Verified postcode
    Las Vegas, United States
  • Clinical Research Alliance ( Site 0101)
    Verified postcode
    Westbury, United States
  • Westmead Hospital ( Site 0901)
    Verified postcode
    Westmead, Australia
  • Biocenter ( Site 0203)
    Verified postcode
    Concepción, Chile
  • IC La Serena Research ( Site 0204)
    Verified postcode
    La Serena, Chile
  • FALP ( Site 0207)
    Verified postcode
    Santiago, Chile
  • Clínica Inmunocel ( Site 0201)
    Verified postcode
    Santiago, Chile
  • Bradfordhill-Clinical Area ( Site 0202)
    Verified postcode
    Santiago, Chile
  • Universitaetsklinikum Essen ( Site 1302)
    Verified postcode
    Essen, Germany
  • Health Pharma Professional Research S.A. de C.V: ( Site 0403)
    Verified postcode
    Mexico City, Mexico

Common questions

What is Hodgkin lymphoma?

Hodgkin lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system.

What is primary mediastinal large B-cell lymphoma?

This is another type of lymphoma that starts in the chest area and also affects a type of white blood cell.

What does 'relapsed or refractory' mean?

Relapsed means the lymphoma has come back after treatment. Refractory means it hasn't responded to previous treatments.

What is pembrolizumab?

Pembrolizumab is a type of immunotherapy that helps your body's immune system fight cancer cells.

What is this 'subcutaneous' injection?

It means the medicine is given with a small needle just under the skin, rather than into a vein (intravenously).

How to find out more

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

Discussion

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