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The University of Southampton
Southampton Clinical Trials Unit

P+R-ICE

Trial Overview

Trial Team

Essential Trial Documentation

Trial Overview

Trial Team

Essential Trial Documentation

Trial Overview

Trial Team

Essential Trial Documentation

Trial Overview

Trial Team

Essential Trial Documentation

Trial Overview

Trial Team

Essential Trial Documentation

Title

An open-label, multicentre, randomised phase II Pembrolizumab in combination with R-ICE chemotherapy in relapsed/refractory diffuse large B-cell lymphoma.

Description

The study has two treatment arms to which participants will be randomised on a 3:1 basis to the experimental arm.

The control arm (Arm A) will be R-ICE for 3 cycles followed by an autologous stem cell transplant (for patients in a CR or PR on the post treatment PET-CT scan). The experimental arm (Arm B) will consist of P+R-ICE for 3 cycles followed by an autologous stem cell transplant (for patients in a CR or PR on the post treatment PET-CT scan) and maintenance Pembrolizumab every 3 weeks for one year. All patients will be randomised at study entry and will be stratified by relapse within 12 months or > 12 months of first line therapy.

  • UK Sites – 9
  • Recruitment target – 65
  • Recruitment period – 24 months

Objectives

Primary:

  • To establish the event-free survival at 1 year in patients treated with P+R-ICE.

An event is defined as any of the following:

  • Progression  / relapse of lymphoma
  • Stable disease at 3 cycles of therapy
  • Commencement of any unplanned non-protocol treatment for lymphoma
  • Death from any cause

Secondary:

  • To examine the longer-term (2 year) efficacy of P+R-ICE
  • To assess whether the addition of pembrolizumab has an impact on the ability to harvest sufficient peripheral blood progenitor cells for autologous stem cell transplant
  • To assess the number of patients achieving CR following treatment with P+R-ICE
  • To document the safety and toxicity profile of P+R-ICE
  • To document the anti-tumour activity of P+R-ICE in patients with relapsed or refractory DLBCL

Tertiary:

  • To correlate clinical outcomes with gene expression analysis of PD-1, PD-L1, PD-L2 and other immune signatures from primary tumour material.
  • To correlate clinical outcomes with immunohistochemical expression in tumour material of PD-1, PD-L1, PD-L2 and other markers in both tumour and microenvironment
  • To correlate clinical outcomes with expression of PD-1, PD-L1/L2 on peripheral blood T-cells. Subdivision of T-lymphocyte sub-sets

Trial Design

Trial Status

Closed to recruitment - in follow-up.

Population

Population over 18 years old with relapsed/refractory diffuse large B-cell lymphoma.

Funder

This trial is funded by Merck Sharp & Dohme (MSD) known as Merck & Co.

Any additional costs will be covered by SCTU.

Senior Trial Manager:

Josh Caddy

Trial Manager:

Amber Cole

Trial Coordinator:

Aleksandra Kusinska

Trial Monitor:

Parys Hatchard

Data Manager:

Zoe Konn

Clinical Trials Data Coordinator:

Oli Seymour

 

Contact Information for trial queries:

Email: PRICEtrial@soton.ac.uk

Phone: 023 8120 5154

SAE Reporting:

Email: ctu@soton.ac.uk

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