Clinical Trial: Study on Pembrolizumab for Recurrent Primary Central Nervous System Lymphoma (PCNSL)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Open-label Single Arm Phase II Study on Pembrolizumab for Recurrent Primary Central Nervous System Lymphoma (PCNSL)

Brief Summary: In summary, there is a high medical need for patients suffering from recurrent/progressive PCNSL. Targeting the PD-1 pathway may represent a very promising novel approach for the treatment of these patients.

Detailed Summary:

The objective of this study are:

PRIMARY OBJECTIVES

  • To evaluate the Overall Response Rate (CR/PR) in patients treated with pembrolizumab for relapsed PCNSL after MTX-based first-line therapy
  • To evaluate the safety of pembrolizumab in subjects diagnosed with recurrent PCNSL

SECONDARY OBJECTIVES

  • To describe Best Overall Response categories (CR, PR, SD, PD) in patients treated with pembrolizumab for relapsed PCNSL after MTX-based first-line therapy
  • To describe individual duration of response over time
  • To assess progression-free survival in this patient population
  • To assess overall survival in this patient population

EXPLORATORY OBJECTIVES

  • To assess PD-L1 as a predictive marker for response to pembrolizumab

Sponsor: Prof. Dr. Matthias Preusser

Current Primary Outcome: Response assessment [ Time Frame: after 24 month ]

Response assessment will be performed according to modified IPCG response criteria on contrast-enhanced cranial MRI-scans


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical adverse events [ Time Frame: after 24 month ]
    clinical adverse Events will be assessed by CTCAE v4.0
  • Laboratory parameters [ Time Frame: after 24 month ]
    adverse events due to laboratory parameters will be assessed by CTCAE v4.0


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: May 17, 2016
Date Started: June 2016
Date Completion: June 2019
Last Updated: June 21, 2016
Last Verified: June 2016