Study on the Safety and Effects of Favezelimab and Pembrolizumab for Patients with Blood Cancers

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What is this study about?

This clinical trial is focused on studying treatments for hematologic malignancies, which are types of cancer that affect the blood, bone marrow, and lymph nodes. The study involves two medications: favezelimab and pembrolizumab. Favezelimab, also known by its code name MK-4280, is a solution given through an intravenous infusion, which means it is administered directly into the bloodstream. Pembrolizumab, also known as Keytruda or MK-3475, is also given as an intravenous infusion.

The purpose of this study is to evaluate the safety and effectiveness of using favezelimab in combination with pembrolizumab, as well as to assess each medication when used alone. Participants in the study will receive these treatments and will be monitored for any side effects or reactions. The study aims to determine the best dose for future research and to understand how well these treatments work together or separately in treating hematologic malignancies.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the effects of the treatment. This includes measuring the concentration of the medications in the blood and observing any changes in the cancer. The study will help researchers gather important information about these treatments, which could lead to better options for patients with hematologic malignancies in the future.

1 joining the study

Upon joining the study, the patient will undergo initial assessments to confirm eligibility. This includes providing a tumor biopsy for analysis and ensuring the disease can be measured accurately through imaging techniques like CT or MRI.

The patient must have a performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.

2 treatment phase

The treatment involves the administration of two medications: favezelimab and pembrolizumab. Both are given as a solution for infusion, which means they are delivered directly into the bloodstream through an intravenous (IV) line.

The specific dosage and frequency of administration will be determined based on the patient’s response and the study’s phase. The goal is to find a safe and effective dose combination.

3 monitoring and assessments

Throughout the study, the patient will be closely monitored for any side effects or adverse events. This includes regular check-ups and blood tests to measure the concentration of favezelimab and pembrolizumab in the serum.

The patient’s response to the treatment will be evaluated through imaging and other diagnostic tests to determine the objective response rate.

4 completion of the study

The study is expected to continue until October 2027. Upon completion, the patient’s overall health and response to the treatment will be assessed to determine the long-term effects and efficacy of the medication combination.

Who Can Join the Study?

The patient must have a measurable disease. This means there should be at least one tumor that can be accurately measured in two directions using special imaging tests like a CT scan or MRI. The tumor should be larger than 15 mm in its longest part or larger than 10 mm in its shortest part.
The patient must be able to provide a tumor biopsy. This is a small sample of the tumor tissue that can be taken from a previous test done within the last 3 months or a new test done during the screening process.
The patient must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale. This is a way to measure how well a patient can perform daily activities. A score of 0 means the patient is fully active, and a score of 1 means the patient is restricted in physically strenuous activity but can carry out light work.
The patient must be within certain age ranges, which typically include adults.
Both female and male patients are eligible to participate.
The study may include vulnerable populations, which means it considers groups that might need special attention or care.

Who Cannot Join the Study?

Patients with certain types of blood cancers, known as hematologic malignancies, cannot participate. These are cancers that start in blood-forming tissue, such as the bone marrow, or in the cells of the immune system.
Individuals who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
Participants who are not part of the specified clinical trial groups are not eligible. This means the study is looking for people with specific characteristics or conditions.
Both men and women can participate, but if someone does not meet other gender-related criteria, they may be excluded.
People who are considered part of a vulnerable population may not be eligible. This term refers to groups who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with limited decision-making capacity.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Orszagos Onkologiai Intezet	Budapest	Hungary
University Of Debrecen	Debrecen	Hungary
University Of Pecs	Pecs	Hungary
Iqwremsz Rdbibbczz Pyv Li Syydzk Dwo Teisdc Dxrw Amckols Iumc Skpsez	Meldola	Italy
Lbydh Giwtgfg Hwksyqbo Ov Adndwm	Athens	Greece
Ubwkraceht Hljoykbw Cwjcasm	Cologne	Germany
Azdernw Umsdg Sormdudwv Lihtci Du Byqfijn	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	20.03.2019
Greece	Not recruiting	20.03.2019
Hungary	Not recruiting	20.03.2019
Italy	Not recruiting	20.03.2019

Trial locations

Investigated drugs:

MK-4280 is an investigational medication being studied for its safety and effectiveness in treating blood cancers. It is being tested both on its own and in combination with another medication to see how well it works and how safe it is for patients.

Pembrolizumab is a medication already used in cancer treatment. In this study, it is being combined with MK-4280 to evaluate if the combination is more effective in treating blood cancers. Pembrolizumab is also being tested alone to assess its safety and tolerability in this specific group of patients.

Hematologic malignancies – These are cancers that begin in the blood-forming tissue, such as the bone marrow, or in the cells of the immune system. They include various types of leukemia, lymphoma, and myeloma. These diseases often result in the production of abnormal blood cells, which can interfere with normal blood cell function. As they progress, they may cause symptoms like fatigue, fever, frequent infections, and easy bruising or bleeding. The progression can vary widely depending on the specific type of hematologic malignancy. They are typically characterized by the uncontrolled growth of blood cells, which can spread to other parts of the body.

Trial ID:

2023-503587-17-00

Protocol code:

MK-4280-003

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of Favezelimab and Pembrolizumab for Patients with Blood Cancers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?