CALYPSO
Research type
Research Study
Full title
MEDI4736 combinations in metastatic renal cell carcinoma
IRAS ID
178883
Contact name
Thomas Powles
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2015-002042-31
Duration of Study in the UK
3 years, 1 months, 31 days
Research summary
This study is being carried out to see if the drugs MEDI4736, savolitinib and tremelimumab can be used alone or in combination to reduce the size of tumours in patients with kidney cancer.
The drugs being tested in this study have an anti-tumour effect and have been tested in pre-clinical and human studies before. MEDI4736 and tremelimumab work with the immune system to help the body fight against tumour cells with immune cells. Savolitinib works to correct a faulty signal which causes tumour growth.
There are strict inclusion and exclusion criteria for this trial. Broadly speaking, patients with histologically confirmed advanced or metastatic renal cell cancer with a component of either clear cell cancer or papillary cancer are eligible.
If a patient is eligible for the study and decides to take part, they will be enrolled into one of 3 stages of the study.
-First stage: aims to find the optimal dose of MEDI4736+savolitinib.
-Second stage: patients with papillary cell cancer will be treated with MEDI4736+savolitinib. Patients with clear cell cancer will be randomised to one of four treatment arms and receive MEDI4736, savolitinib, MEDI4736+savolitinib, or MEDI4736+tremelimumab.
-Third stage: patients will be tested for biomarkers before enrolment, and depending on the results will be allocated to one of 3 treatments (MEDI4736, savolitinib, or MEDI4736+tremelimumab) to see if certain biomarkers are linked to drug efficacy.All patients will have regular scans, blood tests, and reviews with the clinical team. Patients will be offered optional tumour biopsies. The team will compare the patient’s results from before, during and after treatment in order to see how well the drugs work and if they are safe. Treatment will stop after 12 months, or if the patient’s disease progresses.
Patients will only be involved in one stage of the study.
The study is being carried out in hospitals in England, Scotland, Wales, France and Spain.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
15/SC/0640
Date of REC Opinion
8 Dec 2015
REC opinion
Further Information Favourable Opinion