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 ]
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