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

A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants with Hematologic Malignancies

This research study is investigating a new way to treat blood cancers, which are also known as hematologic malignancies. Researchers are testing a combination of two medications: Keytruda (known scientifically as pembrolizumab) and another investigational drug called favezelimab. The main goal of this early-stage study (Phase 1 and 2) is to carefully check how safe this combination treatment is for patients. They will be looking for any side effects and how well people tolerate the treatment, including how many might need to stop treatment due to side effects. They also want to see if the treatment helps shrink or control the cancer. This information will help doctors understand if this new combination could be a useful treatment in the future.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

05 Oct 2023

Hematologic malignancies

What is this study about?

This study is trying to find better ways to treat blood cancers. Blood cancers are conditions that affect the blood, bone marrow, and lymphatic system. The study is looking at two medicines used together: Keytruda, which is already used for some cancers, and a new medicine called favezelimab. Combining treatments is often explored in cancer research to see if they can work better together than alone.

The main purpose of this study, which is in its early 'Phase 1' and 'Phase 2' stages, is to understand if this new combination treatment is safe. Doctors will be carefully watching for any unwanted effects or reactions people might have to the medication. They will also look at how many people need to stop the treatment because of these effects. Safety is always the top priority in these initial studies.

After checking for safety, the study will also look at how effective the treatment is. This means they want to see if the combination helps to shrink the cancer or stop it from growing. By gathering this information on both safety and effectiveness, doctors hope to learn if this new combination could be a promising treatment option for people with blood cancers in the future. It's an important step in developing new medicines.

Key takeaways

This study evaluates a new two-drug combination for blood cancers.
The primary focus is on the safety of the new treatment.
It's an early-stage study (Phase 1/2) to gather initial information.
The treatment involves Keytruda and an investigational medicine called favezelimab.
Both treatment safety and how well it works will be assessed.
Participation would involve regular clinic visits and monitoring.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old. Both men and women are welcome to take part.

The study is specifically for people who have been diagnosed with certain types of blood cancers, sometimes called hematologic malignancies. Your cancer diagnosis would need to fit specific criteria for the study.

There might be other health conditions or past treatments that could affect whether you can join, as the researchers need to make sure the study is right for you. A doctor on the study team would thoroughly check your medical history to see if you meet all the requirements.

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 a type of blood cancer?
Are you generally able to attend regular clinic appointments?
Are you willing to potentially receive new, investigational treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the two new medications, Keytruda and favezelimab, as an infusion (meaning it's given directly into your vein). You would have regular visits to the clinic for these treatments and for check-ups.

During your visits, the study team would carry out tests to monitor your health, check for any side effects, and see how well the treatment is working. This would include things like blood tests, physical examinations, and possibly scans.

The frequency of visits and tests would be explained to you fully by the study team, but typically, in studies like this, regular monitoring is very important. You would continue to be monitored even after your treatment phase ends, to keep track of your health over time. The total length of your participation would depend on how your body responds to the treatment and the study plan, but you would be fully informed about the expected duration.

Potential risks and benefits

Participating in a study like this means you would receive new and investigational treatments that might offer potential benefits, as they could help to control or shrink your blood cancer. However, there are also potential risks, as all medications can have side effects, and this combination is still being studied. These side effects could be mild or more serious, and the study team would explain all known and possible risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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
Germany
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Unverified
Greece
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Unverified
Hungary

Common questions

What kind of cancers is this study for?

This study is specifically for people with certain types of blood cancers, sometimes called hematologic malignancies. Your doctor can tell you if your specific cancer type is included.

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

These are early stages of research. Phase 1 studies mainly check if a new treatment is safe. Phase 2 studies then look at how effective the treatment might be and continue to monitor safety.

What are the treatments involved?

You would receive a combination of two medicines: Keytruda (pembrolizumab) and another investigational drug called favezelimab, given as an infusion.

Will I get better if I join this study?

Researchers hope the treatment will be helpful, but there's no guarantee. The main goal of this early study is to learn more about the safety and potential effects of this new combination.

What happens if I want to stop participating?

You are absolutely free to leave the study at any point, for any reason. Your decision will not affect your ongoing medical care.