A Phase II Study of Pembrolizumab Immunotherapy plus Chemotherapy followed by Autologous Stem Cell Transplantation for Recurrent or Persistent Hodgkin Lymphoma

Full Title

Phase II Study of Second-Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

Purpose

The purpose of this study is to assess the safety and effectiveness of combining pembrolizumab immunotherapy with standard chemotherapy drugs and autologous stem cell transplantation (ASCT) in patients with Hodgkin lymphoma that has come back or continued to grow despite one regimen of prior therapy. Pembrolizumab blocks PD-1, a protein cancer cells use to evade detection by the immune system, thereby enabling the immune system to find and kill cancer cells.

In this study, patients will receive pembrolizumab with three chemotherapy drugs: gemcitabine, vinorelbine, and liposomal doxorubicin. Depending on how well they respond to this treatment, they may also have ASCT. During ASCT, a patient’s own blood-forming stem cells are collected, and he or she is then treated with high doses of chemotherapy. Afterward, the collected stem cells are re-infused back into the patient to re-establish the blood-forming system.

The drugs used in this study are given intravenously (by vein).

Protocol
18-160
Phase
Phase II (phase 2)
Disease Status
Relapsed or Refractory
Investigator
Co-Investigators
ClinicalTrials.gov ID
NCT03618550