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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
NCT ID:
NCT03194867
Pre Assignment Details:
The study consisted of 2 phases: Phase 1 confirmed the feasibility of isatuximab/cemiplimab combination and Phase 2 further evaluated safety, efficacy and pharmacokinetics (PK) of combination versus isatuximab monotherapy. Participants in Phase 2 were randomized in a 1:1:1 ratio to receive either isatuximab monotherapy or combination therapy. The duration of study for a participant included a screening period (up to 21 days) and 3-month post treatment follow-up. Each cycle duration was 28 days.
Recruitment Details:
Participants were screened at 30 sites. The study was conducted i.e. participants were randomized at 29 sites in 10 countries. A total of 3 participants in Phase 1 and 106 participants in Phase 2 were enrolled (Phase 1)/randomized (Phase 2) from 21 Feb 2018 to 20 Mar 2019.
Study:
NCT03194867
Study Brief:
Results Section:
NCT03194867