Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-26 @ 12:55 AM
NCT ID:
NCT04147234
Pre Assignment Details:
All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they (the participants) strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a treatment group if any of the entry criteria were violated.
Recruitment Details:
This open-label, multicenter, 2-arm, dose-escalation trial evaluated BI 1387446 administered intratumorally into superficial lesions as a single agent (Arm A) or in combination with intravenous ezabenlimab (Arm B). The primary objectives were to assess safety, determine the maximum tolerated dose for both treatment approaches, and explore preliminary efficacy signals. Patients with progressive disease could cross over to Arm B after completing Cycle 1, provided Arm B is open for recruitment.
Study:
NCT04147234
Study Brief:
Results Section:
NCT04147234