A Phase 1 Study of Nivolumab in Combination with ASTX727 in B-cell lymphoma (NHL or HL) with an Expansion Cohort in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Brief description of study

This study has two parts: first, the study team wants to figure out the amount with few side effects of two drugs, nivolumab and ASTX727, to use together to treat Diffuse Large B-Cell Lymphoma (DLBCL). The study team will start with a small group of patients, see if there are any side effects, and if not, try the same amount with another small group of patients. If too many patients have side effects, the study team will try a lower amount. The goal is to find the best dose where few to no patients have side effects. Once the study team knows the correct dose they are looking for, they will move to the second part of the study, where they will treat a bigger group of patients to see how well the treatment works and if there are any side effects. If too many patients in the larger group have side effects, the study team will stop taking in more patients. After the study, the study team will look at the data to see how often patients had side effects and how well the treatment worked treating DLBCL.


Clinical Study Identifier: s22-00427
ClinicalTrials.gov Identifier: NCT05272384
Principal Investigator: Catherine M Diefenbach.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Yovanna Giovanis, John P Leonard, Kathryn Dowling, Kenneth B Hymes, Adam Kittai, Katharine Caceres, Danny Perlaza, Emily Logan, Samuel Yamshon, Maxim Kreditor, Megan C Bates, Orel Agami, Tibor Moskovits, Ellaine R Yap, Thaleshravi Prashad, Michael L. Grossbard, Marc Justin Braunstein, Peter Martin, Bruce G Raphael, Marc Schwartz, Megan M. Bulva.


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