This Phase 3 trial is evaluating the effectiveness of brentuximab vedotin (Adcetris) with or without nivolumab (Opdivo) for patients with relapsed or unresponsive classical Hodgkin’s lymphoma (cHL). The main outcome to be measured will be survival outcomes at 4 years after treatment.
Treatment remains challenging for high-risk patients with relapsed or unresponsive cHL. One of the goals of developing new treatments is to improve treatment response. One new treatment combination under investigation is nivolumab plus brentuximab vedotin. These agents are monoclonal antibodies. This type of treatment binds to cancer cells, marking them as targets for the body’s immune system. This leads to cancer cell death.
This trial is evaluating the effectiveness of brentuximab vedotin with or without nivolumab for relapsed or unresponsive cHL. The main outcome will be measured is the number of patients still alive at 4 years without tumor growth or spread (progression-free survival).
Who are they looking for?
This trial is recruiting 340 patients with relapsed or unresponsive cHL. Patients who did not respond to autologous stem cell transplantation (ASCT) must have at least 1 tumor that is 1.5 centimeters or larger. Patients can also participate if they are not eligible for ASCT.
Patients with a known history of pancreas inflammation or viral brain infections cannot participate.
How will it work
This trial will involve two groups of patients. The first group will receive nivolumab and brentuximab vedotin. The second group will receive brentuximab vedotin only. Patients will be followed-up for 4 years.
The main outcome to be measured will be progression-free survival at 4 years. Overall survival (patients still alive) at 4 years will also be measured. Response to treatment will be measured as the overall response rate (the number of patients who respond to treatment).