Clinical Trial TitleNivolumab and combination chemotherapy in treating participants with diffuse large B-cell lymphoma.
Clinical Trial Protocol Description:
Lymphoma is the general name for many related subtypes of cancer that arise from a type of white blood cell called a “lymphocyte.” Non-Hodgkin Lymphoma is the most common type of lymphoma. Although there are more than 50 types of NHL, diffuse large B-cell lymphoma (DLBCL) is the most common type.
Front-line therapy for DLBCL typically consists of rituximab in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) for patients with newly diagnosed DLBCL. It has achieved disease responses as high as 80-90%, but close to 40% of patients’ disease will return.
Nivolumab is a human immunoglobulin monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed death-1 (PD-1, PCD-1,) with immune checkpoint inhibitory and antineoplastic activities. Nivolumab binds to and blocks the activation of PD-1 by its ligands programmed cell death ligand 1 (PD-L1), which is overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2). This results in the activation of T-cells and cell-mediated immune responses against the tumor cells or pathogens.
Immunotherapy represents an important step in improving management of aggressive lymphomas. The purpose of this study is to evaluate nivolumab in combination with R-CHOP in patients with DLBCL/transformed follicular lymphoma (tFL)/high grade B-cell non-Hodgkin’s lymphoma.
Here is the study design: Nivolumab will be given 2 weeks prior to receiving the combination therapy (R-CHOP). After this, nivolumab will be given every 3 weeks in combination with R-CHOP for up to 6 cycles. This treatment is expected to achieve high overall response rates, decrease disease relapse rates and extend disease progression free survival in patients with DLBCL.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have a diagnosis of DLBCL.
- Are an appropriate candidate to receive R-CHOP therapy.
- Have not had prior therapy for your disease.
You will be excluded from the study if any of the following criteria apply to you:
- Have received prior anti-PD-1/L1 treatment for any indication.
- Have known immunodeficiency, or known autoimmune disease or you use immunomodulatory agents.
- Have a condition that requires you take treatment with corticosteroids greater than daily 10 milligrams prednisone equivalents or other immunosuppressive medications.
This is a partial list of inclusion and exclusion criteria.