Active not recruitingPHASE3INTERVENTIONAL

Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma

This study is for people recently diagnosed with advanced Hodgkin lymphoma (stage III or IV). It's comparing two types of treatment: immunotherapy combined with standard chemotherapy. One immunotherapy drug is nivolumab, which helps your body's immune system fight cancer. The other is brentuximab vedotin, which delivers a toxic agent directly to cancer cells. These are given alongside medicines like doxorubicin, vinblastine, and dacarbazine. The main goal is to find out which combination is better at treating the cancer and preventing it from coming back, ultimately improving patients' health and quality of life.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

National Cancer Institute (NCI)

Enrolment target

994

Start

29 Aug 2019

Estimated completion

28 Mar 2027

Results

Results from this study

Posted June 2025

Results have been published for this study.

Primary outcome

Progression Free Survival (PFS)

Will be reported as the number of participants who have experienced death or progression, measured at two years. Progression will be measured according to the 2014 Lugano classification. Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.

Full results on the registry

What is this study about?

This study is looking into better ways to treat a type of cancer called classic Hodgkin lymphoma, especially when it's found at a more advanced stage (stage III or IV). For people diagnosed with this condition, doctors are always searching for the most effective and safest treatments.

In this study, researchers are comparing two different approaches. Both approaches use standard chemotherapy drugs like doxorubicin, vinblastine, and dacarbazine, which are well-known for fighting cancer. On top of these, patients will also receive one of two immunotherapy drugs. Immunotherapy is a treatment that helps your own body's defence system, called the immune system, to recognise and attack cancer cells. One drug, nivolumab, helps the immune system to unmask cancer cells so it can fight them. The other, brentuximab vedotin, is clever because it finds cancer cells specifically and delivers a medicine directly to them to kill them, like a targeted missile.

The main aim is to see which of these combinations (chemotherapy plus nivolumab, or chemotherapy plus brentuximab vedotin) is better at shrinking the cancer and, crucially, keeping it from coming back for a longer time. They will also look at how patients feel during treatment and how the treatments affect their overall health and quality of life. This research is important because it could lead to improved care for people with Hodgkin lymphoma.

Key takeaways

This study compares two new ways to treat advanced Hodgkin lymphoma.
It combines standard chemotherapy with one of two immunotherapy drugs.
The goal is to find treatments that shrink cancer and keep it away longer.
Patients will be involved in regular check-ups and provide feedback on their well-being.
The study includes close monitoring for side effects and how well the treatment works.

Who may be eligible?

To join this study, you must have recently been diagnosed with stage III or IV classic Hodgkin lymphoma and have not been treated for it yet. You need to be at least 12 years old.

Doctors will need to confirm your diagnosis through special tests and make sure your cancer can be measured. You also need to have had specific body scans (like a PET-CT) recently so doctors know exactly where the cancer is.

There are some reasons why you wouldn't be able to join. For example, if you've already had chemotherapy, radiotherapy, or certain antibody treatments for your Hodgkin lymphoma, or if you've had an organ transplant or a stem cell transplant. Also, you shouldn't have had a live vaccine within 30 days before starting the study treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you newly diagnosed with Stage III or IV classic Hodgkin lymphoma?
Are you 12 years old or older?
Have you NOT had any previous cancer treatment for Hodgkin lymphoma?
Have you NOT had an organ or stem cell transplant?
Have you NOT received a live vaccine in the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first be randomly assigned to one of two treatment groups – imagine it like drawing straws to decide which treatment combination you receive. Both groups will get combination chemotherapy alongside one of the immunotherapy drugs (either nivolumab or brentuximab vedotin).

During the study, you'll have regular hospital visits for your treatments and to check how you're doing. This will involve blood tests, physical examinations, and scans like CT and PET scans to monitor the cancer. You’ll also be asked to complete questionnaires about your symptoms and how you're feeling, including questions about your quality of life. The doctors will also collect samples (like blood) for future research. The duration of the treatment and how often you need to attend will depend on the specific treatment plan, and there will be follow-up appointments after your main treatment ends to monitor your health over time.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to new treatments before they are widely available, and close monitoring by a medical team. The hope is that one of these new combinations might work better than current treatments, making you feel better and keeping the cancer away longer. However, like all medical treatments, there are potential risks. The medicines used can cause side effects, and some may be serious. The study doctors will explain all known potential side effects to you. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (730)

Children's Hospital of Alabama
Verified postcode
Birmingham, United States
University of Alabama at Birmingham Cancer Center
Verified postcode
Birmingham, United States
USA Health Strada Patient Care Center
Verified postcode
Mobile, United States
University of South Alabama Mitchell Cancer Institute
Verified postcode
Mobile, United States
Anchorage Associates in Radiation Medicine
Verified postcode
Anchorage, United States
Alaska Breast Care and Surgery LLC
Verified postcode
Anchorage, United States
Alaska Oncology and Hematology LLC
Verified postcode
Anchorage, United States
Alaska Women's Cancer Care
Verified postcode
Anchorage, United States
Anchorage Oncology Centre
Verified postcode
Anchorage, United States
Katmai Oncology Group
Verified postcode
Anchorage, United States
Providence Alaska Medical Center
Verified postcode
Anchorage, United States
Fairbanks Memorial Hospital
Verified postcode
Fairbanks, United States

Common questions

What is immunotherapy?

Immunotherapy is a treatment that helps your body's own immune system find and fight cancer cells more effectively.

What is Hodgkin lymphoma?

Hodgkin lymphoma is a type of cancer that starts in infection-fighting cells of the immune system called lymphocytes, which are part of the lymphatic system.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of the two treatment groups, and neither you nor your doctor will usually know which one you are receiving initially. This is to make sure the comparison is fair.

What does 'Stage III/IV' mean?

This refers to how far the cancer has spread in your body, with Stage III and IV being more advanced stages.

How long will the treatment last?

The study involves several cycles of treatment, and doctors will explain the expected duration based on the specific plan for your group. There will also be follow-up and monitoring for some time after treatment ends.