A Phase 2 Study of Pembrolizumab in Patients With Histiocyte/Dendritic Cell Neoplasms and Biologically Selected Subtypes of Relapsed/Refractory Aggressive Lymphomas
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/Chronic lymphocytic leukemia (CLL)
Current Status: Open to accrual
Phase: II
Principal Investigator: Lunning, Matthew
Contact Information:
Sarah Snook
sarah.snook@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03316573#eligibility
Summary
Primary Objectives
To examine the efficacy (overall response rate) of pembrolizumab in patients with
biologically selected subsets of relapsed/refractory (R/R) biologically selected
subgroups of lymphoma, using 2014 Lugano criteria (31, appendix C).
Secondary Objectives
To examine the rates of complete response, partial response, stable disease, and
progressive disease with pembrolizumab in the group of patients with biologically
selected subsets of R/R biologically selected subgroups of lymphoma and
histiocyte/dendritic cell neoplasms, using the 2014 Lugano criteria (31, appendix C)
To examine the efficacy (overall response rate) of pembrolizumab in patients with
histiocytic sarcoma, follicular dendritic cell sarcoma, and interdigitating dendritic cell
sarcoma using 2014 Lugano criteria (31, appendix C).
To examine the duration of response, duration of complete response, and progressionfree
survival associated with pembrolizumab treatment in this patient population,
using the 2014 Lugano criteria (31, appendix C).
To examine the rates of overall, complete and partial response as well as stable
disease, progression-free survival and duration of remission using the LyRIC criteria
[32, appendix B]
To examine the safety and toxicity of pembrolizumab in patients with biologically
selected subsets of R/R lymphoma and histiocyte/dendritic cell neoplasms.
Exploratory Objectives
To evaluate the expression of PD-L1, genetic integrity of PD-L1/2 locus, and latent
viral infection in a selected subset tumors, and preliminarily correlate those with
clinical outcome.
To study the immune microenvironment and circulating lymphocyte subsets in
patients before and after