Study Comparing MK-4280A (Favezelimab and Pembrolizumab) with Chemotherapy for Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Classical Hodgkin Lymphoma, specifically in patients whose disease has returned or did not respond to previous treatments. The study is testing a new treatment called MK-4280A, which is a combination of two substances: pembrolizumab and favezelimab. These substances are given as a solution through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The trial will compare the effectiveness of MK-4280A against other chemotherapy treatments chosen by doctors, which may include medications like bendamustine or gemcitabine.

The purpose of the study is to see how well MK-4280A works in treating patients with this type of lymphoma compared to other chemotherapy options. Participants in the study will receive either the new treatment or one of the standard chemotherapy treatments. The study will monitor how the disease responds to the treatment and how long the response lasts. It will also track the overall survival of participants and any side effects they may experience during the study.

This trial is designed to help researchers understand if MK-4280A can provide a better treatment option for patients with Classical Hodgkin Lymphoma that has not responded to other therapies. The study will take place over several months, and participants will be closely monitored by healthcare professionals throughout the process to ensure their safety and to gather important information about the treatment’s effectiveness.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to provide a tumor tissue sample, either from a previous biopsy or a new one, to confirm your diagnosis of classical Hodgkin lymphoma.

2 treatment assignment

You will be randomly assigned to receive either the investigational drug MK-4280A or a chemotherapy treatment chosen by your doctor. The investigational drug is a combination of two substances: pembrolizumab and favezelimab.

3 treatment administration

If you are assigned to the MK-4280A group, you will receive the medication through an intravenous infusion. The frequency and dosage will be determined by the study protocol and your doctor.

If you are assigned to the chemotherapy group, you may receive either bendamustine or gemcitabine, also through intravenous infusion. The specific medication, dosage, and frequency will be decided by your doctor.

4 regular monitoring

Throughout the trial, you will have regular check-ups to monitor your health and the effects of the treatment. This will include physical exams, blood tests, and imaging studies to assess the progress of your lymphoma.

5 response assessment

Your response to the treatment will be evaluated using specific criteria to determine if the lymphoma is responding to the treatment. This will help in assessing the effectiveness of the investigational drug compared to the chemotherapy.

6 completion of treatment

The duration of your participation in the trial will depend on your response to the treatment and any side effects you may experience. Your doctor will discuss the next steps with you once your participation in the trial is complete.

Who Can Join the Study?

Has a confirmed diagnosis of classical Hodgkin lymphoma (cHL) that shows up on a special type of scan called FDG-avid.
Has cHL that has either come back after treatment (relapsed) or has not responded to treatment (refractory), and has tried all available treatments that are known to help.
Has had the disease get worse while being treated with a type of medicine called an anti-PD-(L)1 monoclonal antibody (mAb), which could have been given alone or with other treatments.
Can provide a sample of the tumor tissue that is either from the last 5 years or newly taken, and this sample should not have been treated with radiation.
Is within the age range of 18 years and older.
Can be of any gender.

Who Cannot Join the Study?

Patients who have not been diagnosed with Relapsed or Refractory Classical Hodgkin Lymphoma cannot participate. This means the study is only for those whose Hodgkin Lymphoma has returned or did not respond to previous treatment.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is for specific groups of patients.
Both male and female patients can participate, but those who do not meet other criteria cannot join.
Patients who are considered part of a vulnerable population may not be eligible. This refers to groups who might need special protection in research settings.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Hospital Universitario De Salamanca	Salamanca	Spain
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland
Universitaet Leipzig	Leipzig	Germany
Pomeranian Medical University	Szczecin	Poland
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Klinikum Der Landeshauptstadt Stuttgart gKAöR	Stuttgart	Germany
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Hospital Universitario 12 De Octubre	Madrid	Spain
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
Hospital Universitario Virgen De La Victoria	Malaga	Spain
CHU UCL Namur	Yvoir	Belgium
Uehejmquip Hjqcchfb Clyspip	Cologne	Germany
Cfhbai Hatiydfugoc Ed Uqkaksvyvjybv Dq Ludmiop	Limoges	France
Ucajpzp Uglukibdai Hfbqhfer	Uppsala	Sweden
Ujunstsavbtqxg Crzvluv Krgljceqx	Gdansk	Poland
Cazavm Lzgk Bjjfqb	Lyon	France
Hjqnsuke Uqgmmvmqbonnv Mwhnzbj Dv Vsnrdctnmg	Santander	Spain
Hmotuys Hzyrr Mufavg &hipprf 1 rav Gmzdtku Evcrys	Creteil	France
Hskowgqf Vfha daiqwhvs	Barcelona	Spain
Hzfsiwgj Uymlsrkhwxmkm dg A Cbtitf	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	18.10.2022
Czechia	Not recruiting	18.10.2022
France	Not recruiting	18.10.2022
Germany	Not recruiting	18.10.2022
Poland	Not recruiting	18.10.2022
Spain	Not recruiting	18.10.2022
Sweden	Not recruiting	18.10.2022

Trial locations

Investigated drugs:

Favezelimab is a medication that is being studied for its potential to help the immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. In this trial, favezelimab is combined with another medication to see if it can help treat a type of cancer called classical Hodgkin lymphoma, especially in patients whose cancer has come back or has not responded to previous treatments.

Pembrolizumab is a medication that helps the immune system recognize and attack cancer cells. It is already used to treat several types of cancer. In this study, pembrolizumab is combined with favezelimab to see if the combination is more effective in treating classical Hodgkin lymphoma that has returned or is resistant to other treatments. The goal is to see if this combination can improve the chances of stopping or slowing down the cancer.

Relapsed or Refractory Classical Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting a type of white blood cell called lymphocytes. It is characterized by the presence of Reed-Sternberg cells, which are large, abnormal lymphocytes. The disease is termed “relapsed” when it returns after treatment and “refractory” when it does not respond to initial treatment. As the disease progresses, it can spread to other parts of the lymphatic system, including lymph nodes, spleen, and bone marrow. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing slowly and others more rapidly.

Trial ID:

2023-503615-14-00

Protocol code:

MK-4280A-008

NCT ID:

NCT05508867

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing MK-4280A (Favezelimab and Pembrolizumab) with Chemotherapy for Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?