Study of Pembrolizumab for Patients with Relapsed or Refractory Classical Hodgkin’s Lymphoma or Primary Mediastinal Large B-cell Lymphoma

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What is this study about?

This clinical trial is focused on studying two types of blood cancers: Relapsed or Refractory Classical Hodgkin’s Lymphoma and Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma. These are conditions where the cancer has returned or has not responded to previous treatments. The treatment being tested in this study is a medication called Pembrolizumab, also known by its code name MK-3475. Pembrolizumab is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well Pembrolizumab works in treating these specific types of lymphoma. Participants in the study will receive Pembrolizumab every six weeks. The study will monitor the response of the cancer to the treatment, as well as any side effects that may occur. The study aims to gather information on how effective Pembrolizumab is in shrinking or controlling the cancer.

Throughout the study, participants will undergo regular check-ups and tests to assess their health and the progress of the treatment. The study will continue for a period of time to ensure that enough data is collected to understand the effects of Pembrolizumab on these types of lymphoma. The results will help determine if Pembrolizumab can be a beneficial treatment option for patients with these conditions.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of relapsed or refractory classical Hodgkin’s lymphoma or relapsed or refractory primary mediastinal large B-cell lymphoma.

This assessment includes a review of medical history and radiographic imaging to ensure the disease meets specific criteria, such as measurable lesions.

2 treatment administration

The treatment involves the administration of pembrolizumab, a medication given as an intravenous infusion.

The dosage is 25 mg/mL and is administered every 6 weeks.

The infusion is prepared as a solution and given directly into the bloodstream through a vein.

3 monitoring and evaluation

Throughout the study, regular monitoring is conducted to evaluate the response to the treatment.

This includes assessments based on the Lugano classification criteria, which help determine the objective response rate.

Additional evaluations may include measuring the duration of response and monitoring for any adverse events.

4 study completion

The study is expected to continue until the end of 2025.

Upon completion, final assessments are conducted to gather data on the effectiveness and safety of the treatment.

Who Can Join the Study?

Must have a confirmed diagnosis of Classical Hodgkin’s Lymphoma (cHL) or Primary Mediastinal Large B-cell Lymphoma (PMBCL). These are specific types of blood cancer.
Must have a disease that can be measured using imaging tests, with at least one lymph node that is larger than 15 mm in one direction and has not been treated with radiation, or a tumor outside the lymph nodes that is larger than 10 mm in both directions.
For PMBCL patients: Must have a disease that has come back or not responded to treatment, and must have had a relapse after a stem cell transplant.
For cHL patients: Must have a disease that has come back or not responded to treatment, and must have had a relapse during the last treatment plan after receiving at least two cycles of therapy, or within 12 months after finishing the last treatment plan.
Both males and females can participate.
Participants must be within the specified age range, which includes adults.

Who Cannot Join the Study?

Patients who have not experienced a return or worsening of their condition after previous treatment for Classical Hodgkins Lymphoma or Primary Mediastinal Large B-cell Lymphoma cannot participate. Relapsed means the disease has returned after treatment, and refractory means the disease did not respond to treatment.
Individuals who do not fall within the specified age range for the study are excluded. The age range is not specified here, but it is important for eligibility.
Participants must not belong to a vulnerable population, which typically includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Pratia S.A.	Skorzewo	Poland
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Awplhqq Obdlvinkrgi Ophnuoxm Rdllqdb Vgend Sbehq Cgaeparw	Palermo	Italy
Ualfmjdtkosbpa Cnwohke Kegeehpvx	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	07.06.2021
Italy	Not recruiting	07.06.2021
Poland	Not recruiting	07.06.2021

Trial locations

Investigated drugs:

Pembrolizumab

Pembrolizumab (MK-3475) is a medication used in this clinical trial to treat participants with relapsed or refractory classical Hodgkin’s lymphoma or relapsed or refractory primary mediastinal large B-cell lymphoma. It works by helping the immune system recognize and attack cancer cells. Pembrolizumab is given every six weeks to evaluate its effectiveness in improving the response rate in these types of lymphoma.

Investigated diseases:

Primary mediastinal large B-cell lymphoma refractory

Classical Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, which is part of the immune system. It is characterized by the presence of Reed-Sternberg cells, a type of abnormal cell. The disease often begins in the lymph nodes and can spread to other parts of the body. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression can vary, with some cases remaining localized while others spread more extensively.

Primary Mediastinal Large B-cell Lymphoma – This is a subtype of non-Hodgkin lymphoma that typically arises in the thymus gland, located in the mediastinum, the central part of the chest. It is characterized by the rapid growth of large B-cells, a type of white blood cell. The disease often presents with symptoms such as chest pain, cough, and difficulty breathing due to the mass effect in the chest. It can spread to other areas, including the lungs and liver. The progression can be aggressive, requiring prompt medical attention.

Trial ID:

2024-510979-38-00

Protocol code:

MK-3475-B68

NCT ID:

NCT04875195

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pembrolizumab for Patients with Relapsed or Refractory Classical Hodgkin’s Lymphoma or Primary Mediastinal Large B-cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?