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.

NCT05201066 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: CMBG453B12206B2021-004422-302024-515281-14-00
• Study Type: interventional
• Target: 33
• Locations: 15 countries
• Sites: 24

Brief 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.

Conditions

Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic

Keywords

roll-over study; MBG453; sabatolimab; azacitidine; decitabine; venetoclax; spartalizumab; HMA; INQOVI (oral decitabine)

Outcome Measures

Primary Outcomes (2)

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

  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.

  5 years

• Severity of AEs and SAEs

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

  5 years

Secondary Outcomes (1)

• Duration of exposure to sabatolimab

  5 years

Study Arms (6)

sabatolimab + azacitidine

EXPERIMENTAL

Patients will take sabatolimab 800 mg i.v and azacitidine 75 mg/m2/d d1-7 s.c. or i.v./q4w or sabatolimab 400 mg i.v/q2w and azacitidine 75 mg/m2/d d1-7 s.c. or i.v./q4w.

Drug: sabatolimab; Drug: azacitidine

sabatolimab + decitabine

EXPERIMENTAL

Patients will take Sabatolimab 400 mg i.v/q2w and decitabine 20 mg/m2/d d1-5 i.v.

Drug: decitabine; Drug: sabatolimab

sabatolimab + venetoclax + azacitidine

EXPERIMENTAL

Patients will take sabatolimab 200 mg i.v./q2w and venetoclax 400 mg p.o. d1-14/q4wk and azacitidine 75 mg/m2/d d1-7/q4w.

Drug: sabatolimab; Drug: azacitidine; Drug: venetoclax

sabatolimab + spartalizumab + decitabine

EXPERIMENTAL

Patients will take sabatolimab 400 mg i.v./q2w and decitabine 20 mg/m2/d d1-5 i.v. and spartalizumab 100 mg i.v/q2w.

Drug: decitabine; Drug: spartalizumab; Drug: sabatolimab

sabatolimab + HMA

EXPERIMENTAL

Patients will take sabatolimab 800 mg and azacitidine 75 mg/m2/d d1-7 or decitabine 20 mg/m2/d d1-5/ all q4w HMA means hypomethylating agents. Hypomethylating agents are azacitidine and decitabine.

Drug: sabatolimab; Drug: INQOVI (oral decitabine)

sabatolimab

EXPERIMENTAL

Patients will take sabatolimab 800 mg i.v q4w.

Drug: sabatolimab

Interventions

azacitidine DRUG

Solution for subcutaneous injection or intravenous infusion

sabatolimab + azacitidine; sabatolimab + venetoclax + azacitidine

venetoclax DRUG

Tablet for oral administration

sabatolimab + venetoclax + azacitidine

INQOVI (oral decitabine) DRUG

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

sabatolimab + HMA

decitabine DRUG

Solution for intravenous infusion

sabatolimab + decitabine; sabatolimab + spartalizumab + decitabine

spartalizumab DRUG

Solution for intravenous infusion

Also known as: PDR001

sabatolimab + spartalizumab + decitabine

sabatolimab DRUG

Solution for intravenous infusion

Also known as: MBG453

sabatolimab; sabatolimab + HMA; sabatolimab + azacitidine; sabatolimab + decitabine; sabatolimab + spartalizumab + decitabine; sabatolimab + venetoclax + azacitidine

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Local access to commercially available sabatolimab for parent protocol indications.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (24)

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Huntsman Cancer Institute Univ of Utah

Salt Lake City, Utah, 84112 0550, United States

Location

Novartis Investigative Site

Clayton, Victoria, 3168, Australia

Location

Novartis Investigative Site

Florianópolis, Santa Catarina, 88020-210, Brazil

Location

Novartis Investigative Site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Novartis Investigative Site

Changchun, Jilin, 130021, China

Location

Novartis Investigative Site

Tianjin, 300020, China

Location

Novartis Investigative Site

Prague, 128 08, Czechia

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Novartis Investigative Site

Alexandroupoli, 681 00, Greece

Location

Novartis Investigative Site

Pátrai, 265 04, Greece

Location

Novartis Investigative Site

Brescia, BS, 25123, Italy

Location

Novartis Investigative Site

Florence, FI, 50134, Italy

Location

Novartis Investigative Site

Genova, GE, 16132, Italy

Location

Novartis Investigative Site

Milan, MI, 20162, Italy

Location

Novartis Investigative Site

Roma, RM, 00133, Italy

Location

Novartis Investigative Site

Fukushima, 960 1295, Japan

Location

Novartis Investigative Site

Kuala Lumpur, 59100, Malaysia

Location

Novartis Investigative Site

Badalona, Barcelona, 08916, Spain

Location

Novartis Investigative Site

Barcelona, 08036, Spain

Location

Novartis Investigative Site

Madrid, 28009, Spain

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Novartis Investigative Site

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic

Interventions

Decitabine; spartalizumab; sabatolimab; Azacitidine; venetoclax; decitabine and cedazuridine drug combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 21, 2022
• Study Start: February 13, 2023
• Primary Completion (Estimated): February 14, 2028
• Study Completion (Estimated): February 14, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (2); DE (1); US (2); TU (1); GR (2); IT (5); FR (1); JP (1); AU (1); CA (1); CH (1); CZ (1); BR (1); MY (1); ES (3)