NCT05201066

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.

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.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndromes
• Leukemia, Myelomonocytic, Chronic

Interventions

Type	Name	Description
DRUG	decitabine	Solution for intravenous infusion
DRUG	spartalizumab	Solution for intravenous infusion
DRUG	sabatolimab	Solution for intravenous infusion
DRUG	azacitidine	Solution for subcutaneous injection or intravenous infusion
DRUG	venetoclax	Tablet for oral administration
DRUG	INQOVI (oral decitabine)	Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral)

Timeline

• Start date: 2023-02-13
• Primary completion: 2028-02-14
• Completion: 2028-02-14
• First posted: 2022-01-21
• Last updated: 2026-01-07

Locations

24 sites across 15 countries: United States, Australia, Brazil, Canada, China, Czechia, France, Germany, Greece, Italy, Japan, Malaysia, Spain, Switzerland, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study