Brentuximab Vedotin + Nivolumab ± Ipilimumab for Hodgkin's Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking any systemic corticosteroids or other immunosuppressants at least 2 weeks before starting the study treatment. If you are on replacement doses of steroids for adrenal insufficiency, you may continue those. It's best to discuss your specific medications with the study team to ensure compliance with the trial requirements.
What data supports the effectiveness of the drug combination Brentuximab Vedotin, Nivolumab, and Ipilimumab for treating Hodgkin's Lymphoma?
Research shows that Brentuximab Vedotin, when used with other drugs, has been effective in treating Hodgkin's Lymphoma, with a high response rate in patients who had relapsed after previous treatments. Additionally, combining Brentuximab Vedotin with immune-boosting drugs like Nivolumab and Ipilimumab may enhance its effectiveness by activating the body's immune response against the cancer.12345
What is known about the safety of Brentuximab Vedotin, Nivolumab, and Ipilimumab for Hodgkin's Lymphoma?
Brentuximab Vedotin is generally well tolerated but can cause side effects like peripheral neuropathy (nerve damage causing tingling or numbness) and neutropenia (low white blood cell count). Nivolumab, an anti-PD1 immunotherapy, can have unpredictable immune-related side effects such as skin rash, colitis (inflammation of the colon), and lung issues. Ipilimumab's safety profile is not detailed in the provided research, but it is known to have immune-related side effects similar to Nivolumab.45678
What makes the drug combination of Brentuximab Vedotin, Nivolumab, and Ipilimumab unique for treating Hodgkin's Lymphoma?
What is the purpose of this trial?
This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement (recurrent) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.
Research Team
Catherine S Diefenbach
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
Adults with recurrent or refractory classical Hodgkin lymphoma can join this trial. They must have finished previous treatments at least 21 days before, not be pregnant or breastfeeding, and agree to use contraception. Those with serious autoimmune diseases, uncontrolled infections like HIV, severe lung issues, recent monoclonal antibody therapy within 6 months (except ipilimumab in some cases), or a history of certain severe drug reactions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive brentuximab vedotin, nivolumab, and ipilimumab in various combinations across different arms. Treatment cycles vary between 21 and 14 days, with up to 46 cycles in total.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up includes imaging and blood tests.
Treatment Details
Interventions
- Brentuximab Vedotin
- Ipilimumab
- Nivolumab
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