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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

Protocol No
Principal Investigator
Deepak Kilari
BI 754091 and BI 754111 are study drugs that may treat cancer by working with your immune system. The immune system is your body’s natural defense against disease. The immune system sends cells called T-cells throughout your body to detect and fight infections and diseases, such as cancer. For some types of cancer, the T-cells do not work as they should and are prevented from attacking the tumors. The study drugs are antibodies designed to work by blocking 2 different proteins in your T-cells. BI 754111 blocks the protein called LAG-3 (lymphocyte-activation gene 3). BI 754091 blocks the protein called PD-1 (programmed death 1). Blocking LAG-3 and PD-1 allows T-cells and other parts of your immune system to attack tumors. This may shrink tumors and help people live longer. It is thought that by combining the study drugs, they may have more of an effect on cancer cells rather than if each drug was used alone.
Three cohorts (groups) of subjects will be enrolled into the Module A part of the study based on cancer diagnosis, previous treatment and how the cancer responded to the previous treatment that was given. In Cohort 1 patients with gastroesophageal adenocarcinoma will be tested; Cohort 2 will test patients with any type of solid tumor cancer that benefitted previously from an anti-PD-1/PD-(L)1 treatment; and Cohort 3 will test patients that did not benefit from a previous anti-PD-1/PD-(L)1 treatment. The types of solid tumor cancers to be enrolled into Cohort 3 will include: previously treated colorectal cancer, merkel cell carcinoma, and squamous cell skin carcinoma; squamous cancers of the head and neck, cervix, anus,
penis, esophagus, and vulva; hepatocellular carcinoma; biliary tract carcinoma, small-cell lung cancer;
and mesothelioma.
Participating Institutions
Froedtert Hospital