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Immunotherapy trials aim to improve treatments for patients with an aggressive form of blood cancer

Published: 22 August 2022
Blood samples

Two new immunotherapy clinical trials for people with an aggressive form of lymphoma are being launched by researchers in Southampton.

It’s hoped the Pola-RICE and P+R-ICE studies can improve survival and quality of life for patients with diffuse large B cell lymphoma (DLBCL) where the cancer has come back or is resistant to current treatment.

The trials are both led by Professor Andy Davies, Professor of Haematological Oncology at the University of Southampton, and are being run by the Southampton Clinical Trials Unit based at the University’s Centre for Cancer Immunology.

A need for new treatments

DLBCL is a type of non-Hodgkin lymphoma where white blood cells, called B lymphocytes, begin to grow abnormally and cannot do their usual job of fighting infections in the body. Around 5,500 people are diagnosed with diffuse large B cell lymphoma (DLBCL) each year in the UK and will begin treatment.

“In around a third of patients, this first-line treatment will be unsuccessful,” says Professor Davies. “The lymphoma either does not respond or returns after initial slowing of the disease, and in these cases, patients will need to start a second-line therapy.”

One of the second-line treatments currently used is a combination of chemotherapy and immunotherapy drugs called R-ICE followed by a stem cell transplant.

Professor Davies continues: “Unfortunately, around half of patients will still not respond to these treatments and we therefore need to look at additional approaches that can target this aggressive form of cancer and really benefit these patients.”

Boosting the immune system against DLBCL

Both these new trials are looking at whether adding an additional immunotherapy treatment can improve R-ICE therapy for DLBCL patients. Immunotherapies work by boosting the patient’s own immune system to help it find and destroy the cancer.

The P+R-ICE study involves pembrolizumab, a type of drug called a checkpoint inhibitor.

These drugs block a protein on the surface of immune cells which causes the cells to be switched off, and which can be used by cancer cells to stop the immune system from working properly. By blocking this protein, the T cell is thereby stimulated into action and can seek out and destroy cancer cells.

Amber Cole, Trial Manager from P+R-ICE at the Southampton Clinical Trials Unit, says “Pembrolizumab is already used as a treatment for some other cancers such as melanoma and bladder cancer, as well as for Hodgkin lymphoma. Through the P+R-ICE trial we want to see whether it can also be an effective therapy to help improve outcomes for those with DLBCL as well.”

65 people will be recruited into the trial and will be randomly allocated into one of two trial arms. Two thirds will receive the R-ICE plus pembrolizumab, while those in the other arm will remain on R-ICE standard treatment.  The trial opened to recruitment in July and has already recruited its first patients.


Professor Andy Davies
Professor Andy Davies

International collaboration

The second study, Pola-R-ICE, is an international collaboration with a group in Germany, with centres in Spain and Austria also taking part.

In this trial, an immunotherapy drug called polatuzumab vedotin is being added to R-ICE therapy. The treatment contains a cytotoxic drug which is attached to an antibody. This antibody seeks out and binds to a particular receptor on the surface of lymphoma cells. Once bound, it is taken inside the cell where the drug is released, causing the cancerous cell to be destroyed.

Professor Davies says: “Previous studies have shown that giving polatuzumab vedotin in combination with chemotherapy had promising activity in some patients with DLBCLs.

“334 patients will be recruited to this new trial with half receiving the Pola-R-ICE treatment, while a control group will be given R-ICE alone. We will then be able to see whether adding the immunotherapy treatment can improve response rates and survival for DLBCL patients where first-line treatment has not been successful.”

Katy McLaughlin, Senior Trial Manager at the CRUK Southampton Clinical Trials Unit, says: “We are excited to be supporting this international trial with the aim of improving treatment options for lymphoma patients. As a trials unit with a huge experience of running both lymphoma and immunotherapy trials we look forward to working with our European partners to expand the research field for this aggressive form of blood cancer.”

Both these new trials are investigator-led academic trials. Funding for the P+R-ICE trial comes from a grant from Merck Sharp & Dohme (MSD). Pola-R-ICE is funded by a grant from Roche, with the UK arm of the study being endorsed by Cancer Research UK, allowing the trial team access to resources to assist in running the study.

Notes for editors

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

The Pola-R-ICE trial - Polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) versus R-ICE alone in second line treatment of diffuse large B-cell lymphoma (DLBCL)

DLBCL statistics from Cancer Research UK. More information about DLBCL can be found on the CRUK webpage.

R-ICE is a combination of cancer drugs: the immunotherapy rituximab and the chemotherapies ifosfamide, carboplatin and etoposide, and is used to treat relapsed or refractory non-Hodgkin and Hodgkin lymphomas. More information on R-ICE can be found on the CRUK webpage.

The Southampton Clinical Trials Unit (SCTU) is a Cancer Research UK (CRUK) funded CTU with expertise in the design, conduct and analysis of multicentre, interventional clinical trials. The SCTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. Visit the SCTU website.

The University of Southampton is among the top 90 institutions globally (QS World University Rankings 2021) and top 15 in the UK (The Times and The Sunday Times Good University Guide 2021). As a founding member of the Russell Group, we are committed to using our knowledge to help shape economic, cultural and intellectual decisions, playing a part in researching solutions to national and global issues. Visit the UoS website.

Lymphoma is a cancer of the lymphatic system and is divided into two types: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). There are more than 60 types of non-Hodgkin lymphoma, including diffuse large B cell lymphoma (DLBCL), and these are caused by white blood cells called B lymphocytes dividing abnormally, preventing the body’s usual response to infections. There is more information on lymphoma, NHL and DLBCL on the Cancer Research UK and Lymphoma Action websites.

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