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.

ClinicalTrials.gov Identifier: NCT05201066

Novartis Reference Number: CMBG453B12206B

Last Update: Mar 16, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Myelodysplastic Syndromes

Leukemia, Myelomonocytic, Chronic

Phase

Phase 2

Overall status

Recruiting

Start date

Feb 13, 2023

Completion date

Jun 13, 2028

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

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)

Eligibility Criteria

Inclusion Criteria:

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.
Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment.
Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures.
Written informed consent obtained prior to enrolling in the roll-over study.

Exclusion Criteria:

Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol.
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.
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).
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.
Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol.
Local access to commercially available sabatolimab for parent protocol indications.