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.

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05201066

Collaborator

(none)

Enrollment

Arms

68.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic	Drug: decitabine Drug: Spartalizumab Drug: Sabatolimab Drug: Azacitidine Drug: Venetoclax Drug: INQOVI (oral decitabine)	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

Open Label

Primary Purpose:

Treatment

Official 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.

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Dec 2, 2027

Anticipated Study Completion Date :

Jun 13, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Sabatolimab Solution for intravenous infusion Other Names: MBG453 Drug: Azacitidine Solution for subcutaneous injection or intravenous infusion
Experimental: sabatolimab + decitabine Patients will take Sabatolimab 400 mg i.v/q2w and decitabine 20 mg/m2/d d1-5 i.v.	Drug: decitabine Solution for intravenous infusion Drug: Sabatolimab Solution for intravenous infusion Other Names: MBG453
Experimental: 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	Drug: Sabatolimab Solution for intravenous infusion Other Names: MBG453 Drug: Azacitidine Solution for subcutaneous injection or intravenous infusion Drug: Venetoclax Tablet for oral administration
Experimental: 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.	Drug: decitabine Solution for intravenous infusion Drug: Spartalizumab Solution for intravenous infusion Other Names: PDR001 Drug: Sabatolimab Solution for intravenous infusion Other Names: MBG453
Experimental: 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.	Drug: Sabatolimab Solution for intravenous infusion Other Names: MBG453 Drug: INQOVI (oral decitabine) Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral)

Outcome Measures

Primary Outcome Measures

Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [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.
Severity of AEs and SAEs [5 years]
Severity of AEs and SAEs will be measured according to the CTCAE v5.0

Secondary Outcome Measures

Duration of exposure to sabatolimab [5 years]
The length of time patients will be exposed to sabatolimab and will be reported by treatment groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.