This study is evaluating the best dose and side effects of mogamulizumab (Poteligeo) plus pembrolizumab (Keytruda) for relapsed or unresponsive lymphoma. The main outcomes to be measured will be the best dose and side effects of treatment, as well as survival without the tumor growing. This study is being conducted in Sacramento, California, United States.
Mogamulizumab and pembrolizumab are monoclonal antibodies. This treatment is a type of targeted immunotherapy. Monoclonal antibodies bind to cancer cells and help the body’s immune system attack cancer. This leads to cancer cell death.
This study is evaluating the best dose and side effects of mogamulizumab plus pembrolizumab for relapsed or unresponsive lymphoma. One of the main outcomes to be measured will be the number of patients who experience side effects. Survival without cancer growing or spreading (progression-free survival) will also be measured.
Who are they looking for?
This study is recruiting 76 participants with relapsed or unresponsive lymphoma. Patients must agree to use contraception during the study and up to 4 months after the last dose. Patients should have adequate blood cell counts and liver and kidney function tests.
Patients who received anti-cancer therapy 3 weeks before starting study treatment cannot participate. Patients receiving steroid therapy 1 week before starting study treatment cannot participate. Patients with autoimmune disease or active infections cannot participate.
How will it work
This study will involve two groups of patients. In the first group, patients will receive mogamulizumab and pembrolizumab. In the second group, patients will only receive pembrolizumab only. Both groups will receive treatment every 21 days for up to 2 years.
Patients will be followed-up for 6 weeks after finishing the study treatment for side effects. The effectiveness will be evaluated for up to 4 years.