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Brief Title: Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.
Official Title: An Open-label, Multicenter, Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.
Study ID: NCT05201066
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Massachusetts General Hospital ., Boston, Massachusetts, United States
Oregon Health Sciences University Main Center, Portland, Oregon, United States
Novartis Investigative Site, Florianopolis, SC, Brazil
Novartis Investigative Site, Chang Chun, Jilin, China
Novartis Investigative Site, Tianjin, , China
Novartis Investigative Site, Alexandroupolis, Evros, Greece
Novartis Investigative Site, Firenze, FI, Italy
Novartis Investigative Site, Genova, GE, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Kuala Lumpur, , Malaysia
Novartis Investigative Site, Barcelona, Catalunya, Spain
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR