Clinical Trial TitleBrentuximab vedotin and nivolumab with or without ipilimumab to treat relapsed or refractory Hodgkin lymphoma.
Clinical Trial Protocol Description:
Hodgkin lymphoma is a rare cancer, accounting for less than one percent of all cases of cancer in the United States. It is most commonly diagnosed in young adults between the ages of 15 and 35 and in older adults over age 50. The disease is more common in men than in women.
Brentuximab vedotin is a CD30-directed antibody drug conjugate (ADC). It consists of a targeted therapy monoclonal antibody and a chemotherapy drug. The antibody acts like a homing signal, bringing the chemotherapy drug to the lymphoma cells, where it enters the cells and makes them die when they try to divide into new cells. Brentuximab vedotin is already being used to treat Hodgkin disease.
Nivolumab is a drug used alone or with ipilimumab to treat certain cancers. Nivolumab binds to the protein PD-1. Nivolumab may block PD-1 and help the immune system kill cancer cells. It is a type of monoclonal antibody and a type of immune check-point inhibitor.
Ipilimumab bind to a substance called CTLA-4, which is found on T cells. It may block CTLA-4 and help the immune system kill cancer cells. It is also a type of monoclonal antibody and a type of immune checkpoint inhibitor.
The study consists of two treatment groups:
- Group 1 - Subjects will receive brentuximab vedotin and nivolumab through a vein in the arm on Day 1 of each cycle.
- Group 2 - Subjects will receive brentuximab vedotin and nivolumab through a vein in the arm on Day 1 of each cycle. Subjects will also receive ipilimumab through a vein on Day 1 every 4 cycles.
Each cycle lasts 21 days. The study has 34 cycles.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older, with confirmed diagnosis of classical Hodgkin lymphoma.
- Have not received brentuximab vedotin as part of your cancer therapy within 6 months prior to entering the study.
- Have completed all prior treatment at least 21 days prior to entering the study.
- Do not currently smoke tobacco or other agents.
This is a partial list of eligibility criteria.