A Phase 1 Pharmacokinetic - Pharmacodynamic Study of Avelumab (MSB00100718C) in Patients with Previously Treated Advanced Stage Classical Hodgkins Lymphoma (CTMS# 15-2149)
To characterize the pharmacokinetics (PK) of different dosing regimens of avelumab
and its relation to target occupancy (TO) in peripheral blood of patients with classical
Hodgkin¿s Lymphoma (cHL).
To evaluate the overall safety and tolerability of different dosing regimens of
To assess the immunogenicity of different dosing regimens of avelumab.
To evaluate the effect of different dosing regimens of avelumab on pharmacodynamic
biomarkers of tumor immunophenotype and anti-tumor immune response.
To evaluate the anti-tumor activity of avelumab in patients with cHL.
To characterize the association of TO and tumor immunophenotype with tumor
To explore the effects of different dosing regimens of avelumab on the abundance of
T cell clones and the diversity of the T cell repertoire in tumor biopsy tissue and
To explore the effects of different dosing regimens of avelumab on the prevalence
and diversity of tumor antigenic epitopes in tumor biopsy tissue.
To measure the expression of PD-L1/PD-L2 in tumor biopsy tissue and in tumor
Measure time course of potential plasma biomarkers.
¿ To collect exploratory biomarker/genomics samples for biobanking.