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

G
Greg Durm, MD

Primary Investigator

Overview

This study is being done in subjects with advanced and/or metastatic solid tumors. The treatment-specific Module A portion of the study will test the combination of the investigational drugs BI 754091 and BI 754111.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Solid Tumor
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria

In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patient must agree to a pre-treatment biopsy (if archival tissue is not available) and on-treatment tumour biopsy.
  • Male or female patients. Women of childbearing potential (WOCBP)1 and men able to father a child must be willing and able to use highly effective methods of birth control (that result in a low failure rate of less than 1% per year when used consistently and correctly) during trial participation and for at least 6 months after the last administration of trial medication.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 20 Nov 2022. Study ID: 1904395200 (1381-0009)

Interested in the study?

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