Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS)
Status:
Terminated
Trial end date:
2019-04-11
Target enrollment:
Participant gender:
Summary
This is a Phase 1b, open-label, multi-center study comprising a lead-in phase and an
expansion phase. The lead-in phase is a multiple-dose, randomized, parallel-arm,
pharmacokinetic and pharmacodynamic study of avelumab as a single agent in adult patients
with cHL. Patients enrolled in the lead-in phase of this study are required to have relapsed
following a prior autologous or allogeneic HSCT, or to be ineligible for HSCT. Based on the
preliminary TO, safety, and efficacy results from the lead-in phase, the expansion phase will
evaluate the anti-tumor activity and safety of single-agent avelumab utilizing an
intra-patient dose escalation paradigm based on two of the dosing regimens studied in the
lead-in phase in 40 cHL patients in whom an allogeneic HSCT has failed.