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.
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- STATUS
- Recruiting
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- End date
- Jun 13, 2028
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- participants needed
- 70
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- sponsor
- Novartis Pharmaceuticals
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.
Description
The purpose of the roll-over study is to provide access and to collect and assess safety of sabatolimab in participants who are currently receiving treatment with sabatolimab in a Novartis-sponsored study (parent study), that has fulfilled the requirements of the primary objective or was terminated for any reason.
Eligible participants from those studies who were receiving sabatolimab and who, in the opinion of the investigator, would benefit from continued study treatment, may enroll in the study.
The primary objective is to evaluate safety, including serious adverse events (SAE) and adverse events (AE).
The secondary objective is to collect exposure to study treatment (sabatolimab and individual combination agents).
his 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 benefitting from continued study treatment including sabatolimab as judged by the investigator. The treatment with sabatolimab and combination agent(s), as applicable, is continued according to the schedule in the parent study. Adverse events will be collected continuously throughout the study and participants will be questioned about adverse events at each visit.
Once enrolled in the study, participants may continue study treatment with sabatolimab until occurrence of unacceptable toxicity that precludes further treatment, disease progression, withdrawal of consent, discontinuation at the discretion of the investigator, initiation of a new anticancer therapy and/or discontinuation for any other reason.
Details
| Condition | Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic |
|---|---|
| Treatment | Decitabine, Azacitidine, venetoclax, spartalizumab, Sabatolimab, INQOVI (oral decitabine) |
| Clinical Study Identifier | NCT05201066 |
| Sponsor | Novartis Pharmaceuticals |
| Last Modified on | 11 April 2023 |
How to participate?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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