The purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine
administered in combination with nivolumab or nivolumab and ipilimumab in participants
with extensive-stage small cell lung cancer (SCLC).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03026166.
The study planned to enroll three cohorts with approximately 30 participants in each,
including a dose-limiting toxicity (DLT) evaluation phase (the first 12 weeks of any
treatment) and an expansion phase. Initially, up to 12 participants were to be enrolled
into Cohort 1 in order to obtain 6 evaluable participants through the DLT evaluation
period of 12 weeks. Safety data were reviewed by a Safety Monitoring Committee (SMC) for
each cohort during the DLT evaluation phase before the next cohort opened. Once a new
cohort was opened, the previously opened cohort was permitted to continue enrolling
participants for the expansion phase for a total of 30 participants per cohort.
Only two of the planned three cohorts enrolled participants in the study based on the SMC
recommendation after DLTs were identified in Cohort 2.
