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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.

PHASE2RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 12 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-02-13

Primary completion: 2028-02-14

Study completion finish: 2028-02-14

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05201066

Intervention or treatment

DRUG: decitabine

DRUG: spartalizumab

DRUG: sabatolimab

DRUG: azacitidine

DRUG: venetoclax

DRUG: INQOVI (oral decitabine)

Conditions

• Myelodysplastic Syndromes
• Leukemia, Myelomonocytic, Chronic

Image related to Myelodysplastic Syndromes

Condition: Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
DRUG: decitabine and other drugs
Clayton, Victoria, Australia
Sponsor: Novartis Pharmaceuticals

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Novartis Investigative Site

Research sites nearby

Select from list below to view details:

Novartis Investigative Site
Clayton, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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
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
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
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
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
EXPERIMENTAL: sabatolimab Patients will take sabatolimab 800 mg i.v q4w.	DRUG: sabatolimab Solution for intravenous infusion

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Duration of exposure to sabatolimab	The length of time patients will be exposed to sabatolimab and will be reported by treatment groups.	5 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: 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.