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.

NCT ID: NCT05201066

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2028-02-14

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.

Detailed Description

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.

Conditions

Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sabatolimab + azacitidine

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.

Group Type: EXPERIMENTAL

sabatolimab

Intervention Type: DRUG

Solution for intravenous infusion

azacitidine

Intervention Type: DRUG

Solution for subcutaneous injection or intravenous infusion

sabatolimab + decitabine

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

Group Type: EXPERIMENTAL

decitabine

Intervention Type: DRUG

Solution for intravenous infusion

sabatolimab

Intervention Type: DRUG

Solution for intravenous infusion

sabatolimab + venetoclax + azacitidine

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.

Group Type: EXPERIMENTAL

sabatolimab

Intervention Type: DRUG

Solution for intravenous infusion

azacitidine

Intervention Type: DRUG

Solution for subcutaneous injection or intravenous infusion

venetoclax

Intervention Type: DRUG

Tablet for oral administration

sabatolimab + spartalizumab + decitabine

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.

Group Type: EXPERIMENTAL

decitabine

Intervention Type: DRUG

Solution for intravenous infusion

spartalizumab

Intervention Type: DRUG

Solution for intravenous infusion

sabatolimab

Intervention Type: DRUG

Solution for intravenous infusion

sabatolimab + HMA

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.

Group Type: EXPERIMENTAL

sabatolimab

Intervention Type: DRUG

Solution for intravenous infusion

INQOVI (oral decitabine)

Intervention Type: DRUG

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

sabatolimab

Patients will take sabatolimab 800 mg i.v q4w.

Group Type: EXPERIMENTAL

sabatolimab

Intervention Type: DRUG

Solution for intravenous infusion

Interventions

decitabine

Solution for intravenous infusion

Intervention Type: DRUG

spartalizumab

Solution for intravenous infusion

Intervention Type: DRUG

sabatolimab

Solution for intravenous infusion

Intervention Type: DRUG

azacitidine

Solution for subcutaneous injection or intravenous infusion

Intervention Type: DRUG

venetoclax

Tablet for oral administration

Intervention Type: DRUG

INQOVI (oral decitabine)

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

Intervention Type: DRUG

Other Intervention Names

PDR001; MBG453

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.

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

Other protocol-defined Inclusion/Exclusion may apply.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Oregon Health Sciences University

Portland, Oregon, United States

Huntsman Cancer Institute Univ of Utah

Salt Lake City, Utah, United States

Novartis Investigative Site

Clayton, Victoria, Australia

Novartis Investigative Site

Florianópolis, Santa Catarina, Brazil

Novartis Investigative Site

Vancouver, British Columbia, Canada

Novartis Investigative Site

Changchun, Jilin, China

Novartis Investigative Site

Tianjin, , China

Novartis Investigative Site

Prague, , Czechia

Novartis Investigative Site

Toulouse, , France

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Novartis Investigative Site

Alexandroupoli, , Greece

Novartis Investigative Site

Pátrai, , Greece

Novartis Investigative Site

Brescia, BS, Italy

Novartis Investigative Site

Florence, FI, Italy

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Fukushima, , Japan

Novartis Investigative Site

Kuala Lumpur, , Malaysia

Novartis Investigative Site

Badalona, Barcelona, Spain

Novartis Investigative Site

Barcelona, , Spain

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

Zurich, , Switzerland

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Countries

United States; Australia; Brazil; Canada; China; Czechia; France; Germany; Greece; Italy; Japan; Malaysia; Spain; Switzerland; Turkey (Türkiye)

Other Identifiers

2021-004422-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-515281-14-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CMBG453B12206B

Identifier Type: -

Identifier Source: org_study_id