Study of the subcutaneous administration of pembrolizumab in combination with hyaluronidase in patients with relapsed or refractory classical Hodgkin lymphoma and primary mediastinal large B-cell lymphoma

Classical Hodgkin lymphoma (cHL) and primary mediastinal large B-cell lymphoma (PMBCL) are forms of lymphoma characterized by the uncontrolled proliferation of lymphocytes. Lymphocytes are a subtype of white blood cells that are part of the immune system. During the course of treatment, the disease may recur (relapse) or may not respond to treatment from the outset (refractory). For the treatment of relapsed or refractory cHL and PMBCL, the drug pembrolizumab is already approved for administration as an infusion via a venous access site. Pembrolizumab is an antibody that stimulates the immune system to recognize and fight cancer cells. Subcutaneous administration of the drug has not yet been approved as a treatment for these diseases. To improve the absorption and distribution of pembrolizumab, the drug is combined with the enzyme hyaluronidase.

The goal of this Phase 2 study is to investigate the efficacy, safety, and pharmacokinetics of subcutaneous administration of pembrolizumab in combination with hyaluronidase. As part of the study, patients will receive a subcutaneous injection of the combination of pembrolizumab and hyaluronidase every six weeks. This treatment can be continued for up to 18 cycles (approximately two years), as long as there is a response to therapy and the treatment is well tolerated. The study is open-label, meaning that both the medical staff and the patient know which treatment is being administered. Imaging procedures will be performed regularly during the study to monitor the course of the disease. The primary endpoint of the study is the response rate to therapy (objective response rate). Follow-up will continue for up to 4 years. Women and men aged 18 and older with relapsed or refractory cHL or PMBCL are eligible to participate in this study. The disease must not have been previously treated with a PD-1, PD-L1, or PD-L2 inhibitor.