D081KC00001 (MEDIOLA) Advanced Solid Tumours
Research type
Research Study
Full title
A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Olaparib (PARP inhibitor) in Patients with Advanced Solid Tumors
IRAS ID
192492
Contact name
Thomas Ronald Jeffry Evans
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2015-004005-16
Duration of Study in the UK
2 years, 5 months, 5 days
Research summary
This study will look at the effectiveness, safety, and anti-tumour activity (preventing growth of the tumour) of study drugs MEDI4736 in combination with olaparib. It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736 and olaparib is tolerated. The study will also evaluate whether the participant’s immune system becomes activated following treatment or their body produces antibodies (proteins produced by the immune system) against the study drugs.
Participants will be enrolled in 1 of the 4 groups known as cohorts depending of what type of cancer they have: breast, ovarian, gastric or small cell lung cancer.
Approximately 21 centres will be initiated to enrol approximately a total of 139 participants overall in the 4 cohorts; 38 into the breast cohort, 37 into the gastric cohort, 34 into the lung cohort and 30 into the ovarian cohort. The first 40 patients will be enrolled into the exploratory cohorts. Based on an assessment of safety, tolerability, and anti-tumour data, up to an additional 99 patients will be added in expansion cohorts.
MEDI4736 is an antibody which we believe will help the immune system to respond to certain types of cancer. MEDI4736 will be given as a solution as an intravenous (IV) infusion through a needle inserted into a vein in the arm. MEDI4736 will follow olaparib medication and will be given every 4 weeks.
Olapariab (Lynparza) is a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor. PARP is an enzyme which helps to repair DNA which is damaged. Cancer cells have damaged DNA and rely on PARP to repair it. Olaparib is approved by Food and Drug Administration (FDA) and European Medicine Agency (EMA) for some advanced ovarian cancers. This drug is a tablet to be taken by mouth twice daily.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
16/ES/0004
Date of REC Opinion
1 Mar 2016
REC opinion
Further Information Favourable Opinion