A Study of Pembrolizumab and Radiotherapy for Patients with Early-Stage Favorable Classic Hodgkin Lymphoma

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What is this study about?

This study is looking at early-stage favorable classic Hodgkin lymphoma, which is a type of cancer that affects the lymphatic system, a part of the body’s defense system against infections. The lymphatic system includes lymph nodes, which are small bean-shaped structures found throughout the body. In this form of the disease, the cancer is found in only one or two groups of lymph nodes on the same side of the diaphragm, which is the muscle that separates the chest from the belly, and there are no other concerning features present. The treatment being studied involves a medicine called pembrolizumab, which is also known by the code names MK-3475 and lambrolizumab, followed by radiotherapy, which is a treatment that uses high-energy rays to destroy cancer cells.

The purpose of this study is to estimate how well the treatment with pembrolizumab followed by radiotherapy works in people with this type of lymphoma. Pembrolizumab is an anti-PD-1 antibody, which means it works by helping the body’s own immune system recognize and fight the cancer cells more effectively. The medicine is given through an infusion, which means it is slowly delivered into a vein over a period of time. After completing the pembrolizumab treatment, patients will receive radiotherapy to the areas where the cancer was found.

During the study, patients will receive pembrolizumab at a dose of up to 200 milligrams per treatment session, with a maximum total dose of 1200 milligrams over a treatment period of up to six weeks. The study will check how well the treatment works by measuring whether the disease comes back or gets worse within one year after treatment starts. Doctors will also look at the status of the disease after the pembrolizumab treatment and again after the radiotherapy is completed. Additional measurements will include how many patients are alive without their disease getting worse at two years, how many patients are alive at one and two years, any unwanted effects that occur during and after treatment, and how patients feel during and after their treatment through questionnaires.

1 Initial assessment and confirmation

Your diagnosis of classic Hodgkin lymphoma (a type of cancer affecting the lymphatic system) will be confirmed through tissue examination.

Your disease stage will be assessed as early-stage favorable, meaning stage I or II without additional risk factors such as large chest mass, involvement outside lymph nodes, elevated inflammation markers, or involvement of 3 or more lymph node areas.

Required imaging examinations will be performed to confirm your disease characteristics.

2 Pre-treatment evaluations

Blood tests will be performed to check your blood cell counts, including red blood cells (hemoglobin level at least 9 grams per deciliter), white blood cells (at least 1.5 billion per liter), and platelets (at least 100 billion per liter).

Your overall physical condition will be evaluated using a standard scale that measures your ability to perform daily activities.

If applicable, a pregnancy test will be conducted within 7 days before starting treatment.

3 Pembrolizumab treatment phase

You will receive pembrolizumab, a medication that works by helping your immune system fight cancer cells. This medication is also known by the brand name Keytruda.

The medication will be administered through an intravenous infusion (directly into a vein over a period of time).

The concentration of the medication is 25 milligrams per milliliter, prepared as a solution for infusion.

The treatment will continue until your response to therapy is assessed.

4 Response assessment after pembrolizumab

After completing the pembrolizumab treatment phase, your disease status will be evaluated to determine how well the treatment worked.

This assessment will measure your remission status, which indicates whether the cancer has decreased or disappeared.

5 Consolidation radiotherapy

Following pembrolizumab treatment, you will receive consolidation radiotherapy (radiation treatment designed to strengthen the treatment results).

This radiation treatment is directed at specific areas to reduce the risk of cancer returning.

6 Response assessment after radiotherapy

After completing radiotherapy, another evaluation will be performed to assess your disease status.

This will determine the overall effectiveness of the combined treatment approach.

7 Follow-up monitoring at 1 year

At the 1-year mark after starting treatment, you will undergo assessments to evaluate progression-free survival (whether you remain free of cancer progression).

Your overall survival status will also be documented at this time point.

8 Extended follow-up at 2 years

At 2 years after starting treatment, further evaluations will be conducted to assess progression-free survival and overall survival.

Long-term outcomes will be measured to determine the durability of treatment effects.

9 Ongoing safety monitoring and quality of life assessments

Throughout the treatment and follow-up period, any adverse events (unwanted side effects or medical problems) will be monitored and recorded.

You will be asked to complete questionnaires about your quality of life and symptoms at baseline (before treatment starts), during treatment, and during follow-up visits.

Any additional treatments for Hodgkin lymphoma that may become necessary will be documented.

The occurrence of any cancer-related events will be tracked throughout the study period.

Who Can Join the Study?

  • You must have a first diagnosis of classic Hodgkin lymphoma (a type of cancer affecting the lymphatic system) confirmed by tissue examination under a microscope
  • You must have early-stage favorable classic Hodgkin lymphoma, which means stage I or II disease without certain risk factors such as: a large mass in the chest area between the lungs, cancer spread outside lymph nodes, high erythrocyte sedimentation rate (a blood test measuring inflammation), or cancer in 3 or more groups of lymph nodes
  • You must be between 18 and 75 years old at the time of signing the consent form
  • You must be willing and able to provide written permission to participate in the trial before any trial activities begin
  • You must have adequate blood test results within 7 days before signing the consent form: hemoglobin (the protein in red blood cells that carries oxygen) at least 9 grams per deciliter without recent blood transfusion, platelet count (cells that help blood clot) at least 100 thousand per microliter without recent platelet transfusion, and absolute neutrophil count (a type of white blood cell that fights infection) at least 1.5 thousand per microliter
  • You must have an ECOG performance status (a scale measuring how the disease affects daily living abilities) of 0 or 1, meaning you are fully active or restricted only in physically strenuous activity, assessed within 7 days before signing the consent form
  • You must have an estimated life expectancy of more than 3 months
  • If you are a woman able to become pregnant, you must have a negative pregnancy test within 7 days before signing the consent form, not be breastfeeding, and agree to use highly effective birth control methods from enrollment until at least 6 months after the last dose of trial treatment
  • If you are a man who is sexually active with women able to become pregnant, you must agree to use barrier methods such as condoms for birth control and not donate sperm from enrollment until at least 6 months after the last dose of trial treatment

Who Cannot Join the Study?

  • No exclusion criteria have been provided in the available study information.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
University Hospital Jena KöR Jena Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Rostock University Medical Center Rostock Germany
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Staedtisches Klinikum Braunschweig gGmbH Brunswick Germany
Robert Bosch Krankenhaus GmbH Stuttgart Germany
Kliniken Maria Hilf GmbH Moenchengladbach Moenchengladbach Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH Trier Germany
Gesundheit Nord gGmbH Klinikverbund Bremen Bremen Germany
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Ortenau Klinikum Offenburg Germany
Klinikverbund Allgaeu gGmbH Kempten (Allgau) Germany
Maerkische Kliniken GmbH Luedenscheid Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Vincentius-Diakonissen-Kliniken gAG Karlsruhe Germany
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH Paderborn Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie Homburg Germany
Ukqpkmgpqg Msuidbb Chfzls Hjkfaeqnuashyqdcu Hamburg Germany
Ufqndsztboeefvjmtiave Eclop Ajc Essen Germany
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Ookgsuasting Swrakenxxodiipvzl Bielefeld Germany
Ujhrkbnsqr Htzatlva Cuyjgzy Cologne Germany
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Uslrlqxatthitvshbivwu Wlaxfutwx Aww Wuerzburg Germany
Jpqbtoxdbd Gkmb Jtnuuriaersghhycqqkguc Bonn Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.03.2026

Trial locations

Investigated drugs:

Pembrolizumab is a type of immunotherapy medication that helps your immune system fight cancer. It works by blocking a protein called PD-1, which allows your body’s natural defenses to better recognize and attack cancer cells. In this trial, pembrolizumab is being tested as a treatment for early-stage Hodgkin lymphoma.

Radiotherapy is a treatment that uses high-energy rays to kill cancer cells or stop them from growing. In this trial, radiotherapy is given after treatment with pembrolizumab to help destroy any remaining cancer cells in the affected area.

Classic Hodgkin Lymphoma – Classic Hodgkin lymphoma is a type of cancer that affects the lymphatic system, which is part of the body’s immune system. The disease begins when white blood cells called lymphocytes start to grow abnormally and multiply uncontrollably. These abnormal cells typically contain a specific type of cell called Reed-Sternberg cells, which help doctors identify this form of lymphoma. The cancerous cells usually start in the lymph nodes, most commonly in the neck, chest, or underarm area. As the disease progresses, it can spread from one group of lymph nodes to nearby groups and potentially to other organs. Early-stage favorable classic Hodgkin lymphoma refers to cases that are detected early and have certain characteristics that suggest a better response to treatment.

Trial ID:
2024-520138-31-00
Protocol code:
Uni-Koeln-5450
NCT ID:
NCT06916416
Trial Phase:
Therapeutic exploratory (Phase II)

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