This study will investigate the effects of pembrolizumab (Keytruda) and targeted radiation therapy for relapsed or unresponsive Hodgkin lymphoma (HL). This study will measure the rate of complete response (disappearance of all cancer).
The details
Many patients are cured with treatments for HL. Some patients lose response to treatment (relapsed). Others do not respond to treatment at all. It is important to investigate the effects of different treatment combinations for relapsed or unresponsive HL.
This study will measure the rate of complete response (disappearance of all cancer) in the 2 years following pembrolizumab and targeted radiation therapy for relapsed or unresponsive HL.
Who are they looking for?
This study will recruit 22 patients with relapsed or unresponsive HL. To participate, patients must have early stage (I or II) disease and must have been treated with chemotherapy or chemotherapy and radiation. They also must have adequate organ function. Female participants must take preventative measures against becoming pregnant during, and for the 120 days, after the study. Males must also use contraception during and within 120 days after the study.
Patients will be excluded if they have active infections, bulky disease, autoimmune conditions, other cancers. Patients cannot participate if they have had a live vaccine in the last month, if they had more than 1 previous therapy for HL or targeted treatment for HL.
How will it work
All patients will receive the same treatment. Medical imaging (PET/CT scanning) will be used to measure the cancer. Participants will then receive pembrolizumab intravenously on day 1. Patients will receive 4 rounds of treatment. Each round will last 21 days. Medical imaging will be carried out again 14-21 days after treatment has been completed.
Participants who have achieved a complete response will receive targeted radiation therapy. This is radiation to the site of the tumor only. Patients who have not achieved a complete response but have shown some response will undergo biopsy. If the biopsy shows that there is no HL, participants will receive targeted radiation therapy at a higher dose than those with complete response. If the HL has not been cured, patients will receive a higher dose of targeted radiation than those who did not achieve a complete response.
