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NCT Number: 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.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Chronic Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Clayton, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Other protocol-defined Inclusion/Exclusion may apply.

Treatment and study plan

decitabine

Drug

Solution for intravenous infusion

Spartalizumab

Drug

Solution for intravenous infusion

Other names: PDR001

sabatolimab

Drug

Solution for intravenous infusion

Other names: MBG453

Azacitidine

Drug

Solution for subcutaneous injection or intravenous infusion

Venetoclax

Drug

Tablet for oral administration

INQOVI (oral decitabine)

Drug

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

Primary outcomes

  1. Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 5 years

    An AE is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. An AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.

    An SAE is defined as any adverse event [appearance of (or worsening of any pre-existing)] undesirable sign(s), symptom(s), or medical conditions(s) which meets any one of the following criteria: fatal, life-threatening, results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage.

  2. Severity of AEs and SAEs

    Time frame: 5 years

    Severity of AEs and SAEs will be measured according to the CTCAE v5.0

Secondary outcomes

  1. Duration of exposure to sabatolimab

    Time frame: 5 years

    The length of time patients will be exposed to sabatolimab and will be reported by treatment groups.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 21, 2022
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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