Brentuximab Vedotin + Nivolumab for Hodgkin's Lymphoma
Trial Summary
What is the purpose of this trial?
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on corticosteroids or other immunosuppressive medications, you may need to stop them 14 days before enrolling, unless they are for specific conditions like adrenal insufficiency or Hodgkin lymphoma symptoms.
What data supports the effectiveness of the drug combination Brentuximab Vedotin and Nivolumab for treating Hodgkin's Lymphoma?
Research shows that Brentuximab Vedotin, when used with other drugs, has been effective in treating relapsed or refractory Hodgkin's lymphoma, with many patients experiencing a good response and longer periods without disease progression. Additionally, Brentuximab Vedotin and Nivolumab have shown activity in patients with relapsed or refractory Hodgkin lymphoma, suggesting potential effectiveness in this combination.12345
What are the safety concerns for Nivolumab in cancer treatment?
Nivolumab, used in cancer treatment, can cause immune-related adverse events (irAEs), which are side effects where the immune system attacks healthy organs. These events can affect the skin, endocrine system, digestive system, respiratory system, and urinary system, with a 26.82% chance of occurring in any grade and a 6.10% chance of being severe. The risk of death from these events is about 0.17%.678910
What makes the drug combination of Brentuximab Vedotin and Nivolumab unique for treating Hodgkin's Lymphoma?
This drug combination is unique because it combines Brentuximab Vedotin, which targets a specific protein on cancer cells, with Nivolumab, an immune checkpoint inhibitor that helps the immune system attack cancer, offering a novel approach for patients who have not responded to other treatments.15111213
Research Team
Kara M. Kelly
Principal Investigator
Roswell Park Cancer Institute
Eligibility Criteria
This trial is for patients aged 5-60 with newly diagnosed, untreated classical Hodgkin lymphoma stages I or II. They must have proper kidney and liver function, no severe lung conditions, not be on high-dose steroids or immunosuppressants, and not have other active serious illnesses. Pregnant women and those who haven't agreed to use effective contraception are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ABVD chemotherapy regimen on days 1 and 15 of each 28-day cycle, followed by stratification into different arms based on risk status and response.
Immunotherapy
Participants in certain arms receive brentuximab vedotin and nivolumab, with or without involved site radiation therapy (ISRT).
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 3 months for the first year, then every 6 months for the next two years, and annually up to 12 years.
Treatment Details
Interventions
- Brentuximab Vedotin
- Cyclophosphamide
- Etoposide
- Nivolumab
- Vincristine Sulfate
Brentuximab Vedotin is already approved in United States, European Union for the following indications:
- Hodgkin lymphoma
- Systemic anaplastic large cell lymphoma
- Primary cutaneous anaplastic large cell lymphoma
- CD30-expressing mycosis fungoides
- Peripheral T-cell lymphoma
- Hodgkin lymphoma
- Systemic anaplastic large cell lymphoma
- Cutaneous T-cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor