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.

Launched by NOVARTIS PHARMACEUTICALS · Jan 20, 2022

Keywords

ClinConnect Summary

This clinical trial is designed for patients who have already participated in a previous study involving a treatment called sabatolimab and are still experiencing benefits from it. The main goal of this study is to gather important safety information about long-term use of sabatolimab, especially since some side effects might be rare and only show up after extended treatment. This trial is open to individuals aged 43 to 82 (and possibly older), with no restrictions based on gender.

To be eligible for this study, participants must currently be receiving treatment with sabatolimab and have shown that they are benefiting from it, as determined by their healthcare provider. They also need to have followed the guidelines of the previous study and agree to attend scheduled visits for monitoring. Participants can expect regular check-ins to assess their health and the safety of the treatment. It's important to note that individuals who have had serious side effects from sabatolimab or are pregnant or nursing cannot participate. This trial provides an opportunity to continue receiving a treatment that has been helpful while contributing to valuable research on its long-term effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is being treated with sabatolimab, and has fulfilled all requirements in the parent study.
• • 2. Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment.
• • 3. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
• • 4. Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures.
• • 5. Written informed consent obtained prior to enrolling in the roll-over study.
• Exclusion Criteria:
• • 1. Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol.
• • 2. Participant has been permanently discontinued from sabatolimab treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
• • 3. Participant currently has unresolved toxicities for which sabatolimab dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing to resume).
• • 4. Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation.
• • 5. Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol.
• • 6. Local access to commercially available sabatolimab for parent protocol indications.
• • Other protocol-defined Inclusion/Exclusion may apply.