Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS)
Stopped early · Phase 1
Conditions studied: Hodgkins Lymphoma
In brief
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.
Key facts
- Study ID
- NCT02603419
- Run by
- Pfizer
- People needed
- 34
- Starts
- 2016-03-10
- Expected to finish
- 2019-04-11
- Last updated by the study team
- 2020-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope — Duarte, California, United States
- Az. Ospedaliera-Univers. di Bologna Policlinico S.Orsola-Malpighi — Bologna, BO, Italy
- Istituto Clinico Humanitas U.O. Oncologia ed Ematologia — Rozzano, Milano, Italy
- Q2 Solutions — Rosebank, Livingston, United Kingdom
- Oxford University Hospitals NHS Foundation Trust — Headington, United Kingdom
- Leeds Teaching Hospital NHS Trust — Leeds, United Kingdom
- St James's University Hospital — Leeds, United Kingdom
- University Hospitals of Leicester NHS Trust — Leicester, United Kingdom
- University Hospitals of Leicester NHS Trust — Leicester, United Kingdom
- University College London Hospitals NHS Foundation Trust — London, United Kingdom
- UCLH Clinical Research Facility — London, United Kingdom
- The Christie NHS Foundation Trust — Manchester, United Kingdom
- Plymouth Hospitals NHS Trust, Derriford Hospital — Plymouth, United Kingdom
Full record on ClinicalTrials.gov
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