PembroWM
Research type
Research Study
Full title
A phase II trial to investigate the safety and efficacy of rituximab and pembrolizumab in relapsed/refractory Waldenström’s macroglobulinaemia
IRAS ID
244929
Contact name
Jaimal Kothari
Contact email
Sponsor organisation
University College London
Eudract number
2018-001767-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
Waldenström’s macroglobulinaemia (WM) is a rare type of slow growing lymphoma. It develops when a certain type or types of white blood cells, grow abnormally.
There are a number of standard treatments that are currently used in treating WM. Though the cancer often responds to these current treatments, at some point the cancer usually returns. Therefore there is a need to find alternative treatments that are more effective, leading to lasting responses and improved quality of life.
The PembroWM study will investigate whether the drugs rituximab (already used to treat WM) in addition to pembrolizumab (a type of immunotherapy designed to ‘re-awaken’ the immune system) will improve response to treatment.
In this study, 42 adult (aged ≥ 18 years) patients with WM, whose disease has either come back or not responded to treatment, will be given pembrolizumab with rituximab.
Treatment lasts for a maximum of 1 year with pembrolizumab given once every 3 weeks and rituximab a total of 7 times.Patients will be seen regularly during treatment and then yearly until the last patient entering the study completes their 2 year follow-up.
The study will be conducted at NHS hospitals and is expected to last 4 years and 6 months.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/2137
Date of REC Opinion
12 Mar 2019
REC opinion
Further Information Favourable Opinion