This study is intended to collect safety data from participants who completed the parent
protocols but are still benefiting from study treatment. The study population consists of
participants who tolerate study treatment of the parent studies. Collecting safety
information from long-term exposure might offer the unique opportunity to detect rare
Adverse Events.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05201066.
This is a multicenter, open label, roll-over study to collect and assess safety of
sabatolimab in participants who are treated in current Novartis-sponsored parent studies
and who are benefiting from continued study treatment including sabatolimab as judged by
the investigator.
There is no conventional screening period in this study as participants are expected to
transition directly from treatment on the parent protocol to treatment on this roll-over
protocol. Participants who are candidates for the roll-over protocol will be evaluated by
the investigator in the parent protocol for eligibility for the roll-over protocol. If
eligible, the parent protocol end of treatment visit will be performed and the informed
consent for the roll-over protocol will be signed. Participants then continue treatment
on this protocol with the next planned dose of sabatolimab as monotherapy or with other
combination agent(s).
The treatment with sabatolimab and combination agent(s), as applicable, is continued
according to the schedule in the parent study. Adverse events (AEs) will be collected
continuously throughout the study and participants will be questioned about adverse
events at each visit.
Lead OrganizationNovartis Pharmaceuticals Corporation