Evaluate safety & efficacy of multiple BI754091 anti-PD-1 combinations
Research type
Research Study
Full title
An open-label, Phase II, platform trial evaluating safety and efficacy of multiple BI 754091 (ezabenlimab) anti-PD-1 based combination regimens in PD-(L)1 naïve and PD-(L)1 pretreated patient populations with advanced and/or metastatic solid tumours who have had at least one line of systemic therapy
IRAS ID
257541
Contact name
Anja Williams
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Eudract number
2018-002344-81
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 7 months, 0 days
Research summary
The purpose of the study is to compare the response, safety, and survival of patients with advanced cancer receiving treatment with different combinations of anti-cancer drugs which will be identified in treatment-specific Modules. Each Module includes the investigational drug BI 754091 in addition to another anti-cancer drug that will be used to treat specific cancer types. An investigational drug is one that has not been approved by Health Canada or the U.S. Food & Drug Administration (FDA) to treat a certain condition or illness or a certain type of patient. You have been asked to take part in this study because of the type of cancer you have and the prior cancer treatments that were used to treat the cancer.
The primary endpoint of the trial is objective response (OR), defined as best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the Investigator.
REC name
Wales REC 1
REC reference
19/WA/0107
Date of REC Opinion
22 May 2019
REC opinion
Further Information Favourable Opinion