Study Comparing Pembrolizumab and Brentuximab Vedotin for Patients with Relapsed or Refractory Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Hodgkin lymphoma, specifically in cases where the disease has returned after treatment or has not responded to previous therapies. The study will compare two treatments: Pembrolizumab, also known by its code name MK-3475, and Brentuximab Vedotin. Both medications are given as a solution through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate and compare the effectiveness of these two treatments in managing Hodgkin lymphoma. Participants in the study will receive either Pembrolizumab or Brentuximab Vedotin, and their progress will be monitored over a period of time. The study will look at how long patients live without the disease getting worse, known as progression-free survival, and overall survival, which is the length of time patients live after starting the treatment. Additionally, the study will assess the objective response rate, which measures how well the cancer responds to the treatment.

Throughout the study, participants will undergo regular check-ups and imaging tests to track the progress of their treatment. These tests help doctors understand how the cancer is responding to the medication. The study aims to provide valuable information that could improve treatment options for people with relapsed or refractory Hodgkin lymphoma.

1 initial visit

Upon joining the clinical trial, you will attend an initial visit. During this visit, a healthcare professional will review your medical history and conduct a physical examination to ensure you meet the trial’s eligibility criteria.

You will be asked to provide a biopsy sample, which is a small piece of tissue, for further analysis. This can be from an existing sample or a new one obtained within 60 days.

2 randomization

After the initial assessments, you will be randomly assigned to one of two treatment groups. This means you will receive either pembrolizumab or brentuximab vedotin as part of the study.

3 treatment administration

If you are assigned to the pembrolizumab group, you will receive the medication through an intravenous infusion. This involves receiving the drug directly into your bloodstream through a vein. The dosage is 25 mg/mL, and the frequency and duration will be determined by the study protocol.

If you are assigned to the brentuximab vedotin group, you will also receive the medication through an intravenous infusion. The dosage is 50 mg, and the frequency and duration will be determined by the study protocol.

4 regular follow-up visits

Throughout the trial, you will have regular follow-up visits. During these visits, healthcare professionals will monitor your health, assess the effectiveness of the treatment, and check for any side effects.

These visits will include physical examinations, blood tests, and imaging tests such as CT or PET scans to measure the size of any tumors.

5 end of treatment

At the end of the treatment period, you will have a final assessment to evaluate your response to the therapy. This will include similar tests and evaluations as the follow-up visits.

You will be asked to continue using contraception for a specified period after the last dose of the study drug: 120 days for pembrolizumab and 180 days for brentuximab vedotin.

6 long-term follow-up

After completing the treatment, you may be asked to participate in long-term follow-up visits. These visits are designed to monitor your overall health and any long-term effects of the treatment.

The frequency and duration of these follow-up visits will be determined by the study protocol.

Who Can Join the Study?

The patient must have Hodgkin lymphoma that has either come back after treatment (relapsed) or did not respond to the last treatment (refractory).
If the patient has been treated with BV (a type of medication), they must have shown improvement (either a Complete Response or Partial Response) to BV or treatments containing BV.
The patient must have a disease that can be measured by a CT scan or a combined CT/PET scan. The disease must have at least one lesion that is large enough to measure accurately.
The patient must be able to provide a sample from a lymph node biopsy for testing. This can be from a previous biopsy done more than 60 days ago or a new one done within 60 days before the study starts.
The patient must have a performance status of 0 or 1 on the ECOG Performance Scale, which means they are fully active or have some symptoms but do not need to stay in bed.
The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
Female patients who can have children must agree to use a reliable method of birth control during the study and for a certain period after the last dose of the study drug.
Male patients who can father children must agree to use a reliable method of birth control starting with the first dose of the study drug and for a certain period after the last dose.

Who Cannot Join the Study?

Patients who have not been diagnosed with Hodgkin lymphoma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are not willing to undergo autologous stem-cell transplantation (auto-SCT) or allogeneic stem-cell transplantation (allo-SCT) cannot participate. These are procedures where stem cells are used to replace damaged or destroyed bone marrow.
Patients who are not willing to provide clinical and imaging data for the study cannot participate.
Patients who are not willing to have their progress assessed by an independent review cannot participate.
Patients who are not willing to compare their progression-free survival (PFS) and overall survival (OS) with other treatment arms cannot participate. PFS is the length of time during and after treatment that a patient lives with the disease without it getting worse. OS is the length of time from the start of treatment that patients are still alive.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Centre Hospitalier Universitaire De Lille	Lille	France
Universitaet Leipzig	Leipzig	Germany
Institut Gustave Roussy	Villejuif	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Cyuqoe Haomwgggwfh Uupngwumrvkme Df Ddqqs	Dijon	France
Aoarqbzdep Povqsneo Hkdjrfkl Dd Pnbtz	Paris	France
Upmdpex Uozvqaremi Hzevhxee	Uppsala	Sweden
Abrsqre Umalt Smpfwiyhq Loslta Ds Baheyef	Bologna	Italy
Sydholyi Pyhdltplk Sng z oerl	Gdynia	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.11.2022
France	Not recruiting	01.11.2022
Germany	Not recruiting	01.11.2022
Italy	Not recruiting	01.11.2022
Poland	Not recruiting	01.11.2022
Sweden	Not recruiting	01.11.2022

Trial locations

Investigated drugs:

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer. It does this by blocking a specific protein that prevents your immune system from attacking cancer cells. By blocking this protein, pembrolizumab allows your immune system to better recognize and destroy cancer cells.

Brentuximab Vedotin is a targeted therapy used to treat certain types of cancer. It combines an antibody with a chemotherapy drug. The antibody part of the medication helps it find and attach to cancer cells, while the chemotherapy drug helps kill these cells. This combination allows the medication to specifically target and destroy cancer cells while minimizing damage to healthy cells.

Hodgkin lymphoma – Hodgkin lymphoma is a type of cancer that originates in the lymphatic system, which is part of the body’s immune system. It is characterized by the presence of Reed-Sternberg cells, which are abnormal, large lymphocytes. The disease typically begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, bone marrow, and lungs. As it progresses, it may cause symptoms such as painless swelling of lymph nodes, fever, night sweats, and weight loss. The progression of Hodgkin lymphoma can vary, with some cases advancing slowly and others more rapidly. The disease is often identified through a combination of physical examination and imaging studies.

Trial ID:

2022-500400-22-00

Protocol code:

MK-3475-204

NCT ID:

NCT02684292

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Pembrolizumab and Brentuximab Vedotin for Patients with Relapsed or Refractory Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?