Last Update: Jun 23, 2023
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:
Novartis Reference Number:CMBG453B12206B
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.

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.

Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Phase 2
Recruiting
70
Feb 13, 2023
Jun 13, 2028
All
18 Years - (Adult, Older Adult)

Interventions

Drug

Azacitidine

Solution for subcutaneous injection or intravenous infusion
Drug

decitabine

Solution for intravenous infusion
Drug

INQOVI (oral decitabine)

Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral)
Drug

Sabatolimab

Solution for intravenous infusion
Drug

Spartalizumab

Solution for intravenous infusion
Drug

Venetoclax

Tablet for oral administration

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.

Study Location

Novartis Investigative Site

Recruiting

Alexandroupolis,Evros,681 00,Greece

Novartis Investigative Site

Recruiting

Barcelona,Catalunya,08036,Spain

Oregon Health and Science Uni

Recruiting

Portland,Rachel Mahoney (503-494-8311) email: [email protected] -- Elie Traer,97239 - Oregon,United States

Massachusetts General Hospital .

Recruiting

Boston,Olivia Green email: [email protected] -- Andrew M Brunner,02114 - Massachusetts,United States

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals