PLACARD
Research type
Research Study
Full title
Phase Ib/II trial of Histone Deacetylase Inhibitor CXD101 in combination with Programmed Cell Death Protein-1 Inhibitor Pembrolizumab for relapsed or refractory Diffuse Large B-cell Lymphoma
IRAS ID
261653
Contact name
Graham Collins
Contact email
Sponsor organisation
University College London
Eudract number
2018-004522-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 6 months, days
Research summary
Diffuse large B cell lymphoma (DLBCL) is the most common subtype of Non-Hodgkin Lymphoma (NHL). It is a high grade, aggressive B-cell lymphoma, and without treatment, survival is in the order of months. There are a number of standard treatments that are currently used in treating DLBCL, depending on the stage of the disease. Though the cancer often responds to these current treatments, there are instances where the cancer does not respond or where it returns. There is, therefore, a need to find alternative treatments that are more effective, leading to lasting responses.
PLACARD study will investigate whether CXD101, a type of drug that blocks substances (enzymes) in the body called histone deacetylases and pembrolizumab, a type of immunotherapy designed to 're-awaken' the immune system, will improve response to treatment.
There are 2 distinct stages to the study. The first stage of the study, called the safety run in stage, aims to find the highest tolerated dose of CXD101 which be given with the pembrolizumab. Up to 12 adult (aged ≥18 years) patients (3 patient cohort) with DLBCL, whose disease has either come back or not responded after 2 rounds of treatment will be recruited at this stage and given CXD101 and pembrolizumab.
If there are no serious side effects, the second stage of the study, called the expansion stage, will recruit a further 33 patients.
Patients will be seen regularly during treatment and then every 3 months until one year after treatment and then annually thereafter until the last patient entering the study completes their 1 year follow up.
The study will be conducted at NHS hospitals and is expected to last 5 years and 6 months.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0377
Date of REC Opinion
28 Oct 2019
REC opinion
Further Information Favourable Opinion