Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of Nivolumab for Early Stage Hodgkin Lymphoma in Patients with Good Prognosis

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Hodgkin Lymphoma, specifically in its early stages when the disease is not widespread and does not show severe symptoms. The trial aims to explore the effectiveness of a treatment approach that does not involve radiation. Instead, it uses chemotherapy alone for patients who are considered to have a good prognosis. This means that the patients have a low risk of the disease worsening, as determined by specific tests that measure the size of the tumor and its activity after two cycles of chemotherapy.

The study will also investigate the use of a medication called Nivolumab for patients who are at a higher risk of the disease progressing. Nivolumab is given through an infusion, which means it is administered directly into the bloodstream. The trial will look at how well this medication works in combination with chemotherapy for those who do not respond as well to the initial treatment. The goal is to see if this combination can help prevent the disease from coming back or getting worse over a period of three years.

Participants in the study will undergo regular monitoring to track their progress and response to the treatment. The study will assess the safety and effectiveness of the treatment plan, including the use of Nivolumab, to determine if it can improve outcomes for patients with early-stage Hodgkin Lymphoma. The trial will continue until 2026, with the aim of providing valuable insights into the best treatment strategies for this type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests are performed to check levels of bilirubin, ALT, AST, hemoglobin, neutrophils, platelets, and creatinine.

  2. Step 2

    Chemotherapy cycles

    The treatment begins with two cycles of chemotherapy using a regimen known as ABVD. This includes the drugs doxorubicin, bleomycin, vinblastine, and dacarbazine.

    Each cycle lasts for 28 days, with the medication administered on specific days within the cycle.

  3. Step 3

    Interim PET scan

    After completing the two chemotherapy cycles, a PET scan is conducted. This scan helps to assess the response to the treatment by measuring the metabolic activity of the tumor.

  4. Step 4

    Treatment evaluation

    The results of the interim PET scan determine the next steps. If the scan is negative, indicating a good response, the treatment may continue with chemotherapy alone.

    If the scan is positive, indicating a higher risk, additional treatment with nivolumab may be considered.

  5. Step 5

    Nivolumab administration

    For patients requiring additional treatment, nivolumab is administered. This medication is given through an intravenous infusion.

    The frequency and duration of nivolumab administration depend on the individual treatment plan.

  6. Step 6

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor health and response to treatment. This includes physical exams, blood tests, and imaging studies as needed.

    The follow-up period aims to evaluate the long-term efficacy and safety of the treatment.

Who can join the trial?

13 criteria

  • Patients must be male or female and aged between 18 and 70 years.
  • The level of total bilirubin in the blood must be less than 2 times the upper limit of normal, unless the patient has a known condition called Gilbert syndrome.
  • The levels of liver enzymes ALT or AST must be less than 3 times the upper limit of normal.
  • Female patients must either be postmenopausal for at least 1 year or, if they can have children, agree to use 2 effective methods of birth control or agree to not have sexual intercourse.
  • Male patients must agree to use barrier methods of birth control or agree to not have sexual intercourse.
  • Patients must not have received any treatment for classical Hodgkin Lymphoma and must have early-stage disease (stage I or II A) without large tumors, as defined by specific criteria.
  • Patients must have a confirmed diagnosis of classical Hodgkin Lymphoma according to the World Health Organization's classification.
  • Patients must have an ECOG performance status of 0 to 2, which is a scale that measures how well a patient can perform daily activities.
  • Patients must have a hemoglobin level greater than 8 grams per deciliter.
  • Patients must have an absolute neutrophil count of at least 1,000 per microliter, which is a measure of a type of white blood cell important for fighting infections.
  • Patients must have a platelet count of at least 100,000 per microliter, which is important for blood clotting.
  • Patients must voluntarily provide written consent to participate in the study.
  • The level of serum creatinine must be less than 2.0 milligrams per deciliter, and/or the creatinine clearance must be greater than 40 milliliters per minute, which are measures of kidney function.

Who cannot join the trial?

6 criteria

  • Patients with **bulky lesions**. These are large areas of cancer that can be seen on scans.
  • Patients with **constitutional symptoms**. These are general symptoms like fever, night sweats, or weight loss.
  • Patients who do not have a **low MTV**. MTV stands for Metabolic Tumor Volume, which is a measure of how much cancer is in the body.
  • Patients who do not have a **negative interim PET** after 2 courses of ABVD. A PET scan is a type of imaging test that helps show how the cancer is responding to treatment. ABVD is a common chemotherapy treatment for Hodgkin Lymphoma.
  • Patients who are not in the **early stage I-IIA** of Hodgkin Lymphoma. This refers to the early stages of the disease.
  • Patients who are not considered **low-risk**. This means they have factors that make their cancer more likely to come back or be harder to treat.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

ABVD is a combination chemotherapy regimen used to treat Hodgkin's lymphoma. It includes four different medications that work together to kill cancer cells and stop them from growing. This regimen is often used as an initial treatment for patients with early-stage Hodgkin's lymphoma. The goal of using ABVD in this trial is to determine if it can effectively treat patients without the need for radiation therapy, especially in those with a good prognosis.

What is already known about the treatment

ABVD Chemotherapy – This medication regimen is administered intravenously and is used in the treatment of early-stage classical Hodgkin Lymphoma without bulky lesions and constitutional symptoms. It is currently well-established in medical literature as a standard treatment for Hodgkin Lymphoma. The main therapeutic indication is to treat Hodgkin Lymphoma, particularly in patients with a good prognosis. The mechanism of action involves targeting and killing rapidly dividing cancer cells through a combination of drugs that interfere with DNA replication and cell division. ABVD is classified pharmacologically as a combination chemotherapy regimen, consisting of Adriamycin (doxorubicin), Bleomycin, Vinblastine, and Dacarbazine.

Investigated diseases

Early Stage Classical Hodgkin Lymphoma – This is a type of cancer that affects 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. In its early stages, the disease may not present with bulky lesions or constitutional symptoms like fever, night sweats, or weight loss. The progression of the disease can vary, but it typically involves the spread of cancerous cells to nearby lymph nodes. The disease is often detected through imaging tests and biopsies, which reveal the characteristic cells. Early-stage Hodgkin Lymphoma is generally considered more manageable than advanced stages.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515063-66-00Protocol codeNBK132/1/2020Estimated enrolment145 patientsSponsorMedical University Of Gdansk

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).