A phase II/III trial of pembrolizumab in mesothelioma (IND227)
Research type
Research Study
Full title
A PHASE II/III RANDOMIZED STUDY OF PEMBROLIZUMAB IN PATIENTS WITH ADVANCED MALIGNANT PLEURAL MESOTHELIOMA
IRAS ID
253236
Contact name
Dean Fennell
Contact email
Sponsor organisation
Canadian Cancer Trials Group
Eudract number
2016-002286-60
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Malignant pleural mesothelioma is a rare form of cancer, associated with exposure to asbestos. Standard treatment is a combination cisplatin (or carboplatin) and pemetrexed. Recently, there have been studies to suggest that adding another immunotherapy drug (pembrolizumab) to this combination could extend survival and delay progression of the disease.
In this trial, we will compare standard chemotherapy (cisplatin and pemetrexed - Arm A) versus chemotherapy (cisplatin and pemetrexed) plus immunotherapy (pembrolizumab - Arm B). Half of the patients who take part will be assigned to each group.
Patients will come in to hospital for treatment every 3 weeks. The patients in Arm A will have 6 treatment visits. Patients in Arm B will have up to 35 visits – there are more visits in this arm because treatment with immunotherapy (pembrolizumab) will continue after the chemotherapy stops – so for up to two years in total. During these visits, patients will have some blood tests to make sure they are well enough to receive treatment and will sometimes be asked to complete a questionnaire, asking about their health and quality of life. Patients will also have CT scans, every 6-12 weeks to measure changes in the size of their tumour.
At the end of the trial we will compare the two groups of patients to see if there are differences in terms of survival, how long we can stop the disease getting worse (progressing), quality of life and costs of treatment.
In addition to these assessments, we will collect blood samples and tumour samples which will be sent to a lab in Canada. They will be analysed to tell us more about how the treatments work and whether there are some patients who may benefit more from treatment than others. This might help us to target treatments to those most likely to respond in the future.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0147
Date of REC Opinion
8 Jul 2019
REC opinion
Further Information Favourable Opinion