NCT03331731

A Phase II Study to Determine Pembrolizumab as Frontline Treatment of Patients With Hodgkin Lymphoma

A Multi-centre Phase II Study to Determine the Response Kinetics, Safety and Efficacy of Pembrolizumab as Frontline Treatment of Patients With Hodgkin Lymphoma Considered Unsuitable for ABVD

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test how safe and effective the research study drug, pembrolizumab is as a treatment for patients with Hodgkin lymphoma who have not previously been treated for this disease and are unsuitable for standard treatment (adriamycin, bleomycin, vinblastine, dacarbazine ABVD).

Detailed description

The study is a single arm, open label, phase II, international, multi-centre study. Sample size will be 25 evaluable patients with a recruitment period of 2 years. Patients will be administered 200mg pembrolizumab IV every 3 weeks up to 35 cycles or 2 years. Patients will be followed-up for 1 year.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	pembrolizumab	Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

Timeline

• Start date: 2018-11-29
• Primary completion: 2023-02-16
• Completion: 2024-07-01
• First posted: 2017-11-06
• Last updated: 2023-08-21

Locations

6 sites across 2 countries: Australia, New Zealand