Hodgkin Lymphoma Treatment Study
Hodgkin lymphoma is a disease in which cancer cells form in the lymph system, part of the body’s immune system. Hodgkin lymphoma has been divided into two main classifications, classifications, classical Hodgkin lymphoma (which accounts for about 95% of all cases of Hodgkin lymphoma) and lymphocyte predominant Hodgkin lymphoma.
Brentuximab vedotin and pembrolizumab are monoclonal antibodies. Monoclonal antibodies are a relatively new type of “targeted” cancer therapy.
The purpose of this study is to evaluate pembrolizumab in the treatment of participants with relapsed or resistant to treatment (refractory) classical Hodgkin’s lymphoma. Participants will be randomized to receive either pembrolizumab or brentuximab vedotin for up to 35 three-week cycles of treatment. The primary hypotheses is that pembrolizumab will prolong disease free survival and overall survival.
In order to participate you must meet the following criteria:
Have had classical Hodgkin’s disease return after receiving therapy or are resistant to treatment, that is, did not achieve a complete or partial remission, AND meet one of the following criteria:
- Has failed to achieve a response or has disease progression after autologous stem cell transplantation.
- Are not an autologous stem cell transplantation candidate due to chemotherapy-resistant disease, advanced age (65 years or older), or any significant coexisting medical condition (cardiac, renal, pulmonary, or liver dysfunction).
- Have received at least 2 prior multi-agent chemotherapy regimens that did not include brentuximab vedotin.
- Have adequate organ function.
- For female and male subjects of childbearing potential: Are willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication.
You will be excluded from the study if any of the following criteria apply to you:
- Have received previous treatment for your disease with brentuximab vedotin.
- Have had a prior monoclonal antibody treatment within 4 weeks prior to first dose of therapy in the study or have not recovered from side effects due to drugs administered more than 4 weeks earlier.
- Have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.
- Have undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
- Have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD30, anti-CD137, or CTLA-4 antibody (including ipilimumab) or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
This is a partial list of elgibility requirements.