MEDI4736 with Tremelimumab in advanced solid tumours
Research type
Research Study
Full title
A Phase 1 Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Tremelimumab (Anti-CTLA-4 Antibody) in Subjects with Advanced Solid Tumors
IRAS ID
201803
Contact name
Thomas Powles
Contact email
Sponsor organisation
MedImmune, LLC
Eudract number
2015-005518-31
Clinicaltrials.gov Identifier
119062, IND Number
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Cancers are recognised by the immune system. The immune system may control or even eliminate tumours. However, there are mechanisms that may interrupt the immune system’s ability to function. The study medications administered in this study, MEDI4736 and tremelimumab, are laboratory-created antibodies. Antibodies are protective proteins produced by the human body’s immune system in response to a foreign substance, such as bacteria or viruses, or abnormal cells in the body, including cancer cells. Antibodies bind to these abnormal cells to remove them from the body. The Sponsor believes that MEDI4736 and tremelimumab (study medications) may turn off some of the mechanisms that prevent the immune system from identifying and removing cancer from the body. This study will occur in two parts, Dose-exploration (Part 1) and Dose-expansion (Part 2). The enrolment for Part 1 (Dose-exploration) has been completed. The main purpose of Part 2 is to continue to assess the safety and tolerability of the MEDI4736 and tremelimumab doses and dosing schedule determined by the Sponsor during Part 1. The study will be conducted at approximately 100 clinical research sites in several countries. Participants in this study must be 18 years of age or older with a specific type of advanced cancer that has worsened or failed to improve following previous treatment or are unable to tolerate standard therapy that is usually given for their cancer type. When a participant is enrolled, they will receive both study medications every 4 weeks for up to 4 doses of each. After these 4 doses, the participant will continue to receive MEDI4736 alone every 2 weeks. The entire treatment schedule may last up to 1 year.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/0919
Date of REC Opinion
13 Jul 2016
REC opinion
Further Information Favourable Opinion