SHS_492325 PAGJ CPFI 15268

A Phase 1 Pharmacokinetic-Pharmacodynamic Study Of Avelumab (MSB0010718C) In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma

This is a Phase 1b dose-finding study to evaluate the pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of avelumab (MSB00100718C) in adult patients with relapsed or refractory classical Hodgkin's Lymphoma (cHL). Patients enrolled in this study are required to have failed a prior course of high dose chemotherapy as a part of a first-line salvage chemotherapy regimen for cHL. The primary purpose of this study is to assess the pharmacokinetics, biological activity and early signs of efficacy of various avelumab dosing regimens in patients with cHL.

Inclusion Criteria:

•Histological confirmation of classical Hodgkin's Lymphoma (cHL) with relapsed or refractory disease
•At least 1 FDG-PET-avid (Deauville 4/5) measurable lesion >1.5 cm as defined by Response Criteria for Malignant Lymphoma
•A pre-treatment tumor biopsy (lymph node or bone marrow) is mandatory at baseline for the expansion phase. A pre-treatment tumor biopsy in the lead in phase and an on-treatment biopsy in both phases are optional.

Exclusion Criteria:

•Prior allogeneic stem cell transplantation for patients in dose expansion cohorts only
•Prior therapy with an anti-PD-1 or anti-PD-L1. May be enrolled if patient had stopped prior anti-PD1 therapy more than one year ago and had responded.
•Systemic anti-cancer therapy less than 2 weeks of study entry
•Prior palliative radiotherapy to lesion(s) permitted as long as there is at least one target lesion evaluable for anti-tumor activity
Phase Ib
John Pagel, M.D.
Neil Bailey
  • Swedish Medical Center