Platform Trial Evaluating Safety and Efficacy of BI 754091 Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours.

Official Title

An Open-label, Phase II, Platform Trial Evaluating Safety and Efficacy of Multiple BI 754091 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

Summary:

The aim of this study is to assess the efficacy of BI 754091 in combination with other checkpoint inhibitors or anticancer medications in diverse tumour type cohorts.

Trial Description

Primary Outcome:

• 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

• Duration of response (DoR), defined as the time from first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death among patients with OR
• Disease control (DC), defined as best overall response of CR, PR, or stable disease (SD) according to RECIST v1.1 as assessed by the Investigator
• Progression-free survival (PFS), defined as the time from first treatment until PD or death from any cause, whichever occurs earlier

View this trial on ClinicalTrials.gov