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.

Myelodysplastic Syndromes Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05201066
• Other study ID #: CMBG453B12206B
• Status: Recruiting
• Phase: Phase 2
• Start date: February 13, 2023
• Est. completion date: February 14, 2028

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 14, 2028
• Est. primary completion date: September 20, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 99 Years

Eligibility

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.

5. Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol.

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

Other protocol-defined Inclusion/Exclusion may apply.

Related Conditions & MeSH terms

• Leukemia, Myelomonocytic, Chronic
• Myelodysplastic Syndromes

Intervention

Drug:
• decitabine
Solution for intravenous infusion
• spartalizumab
Solution for intravenous infusion
• sabatolimab
Solution for intravenous infusion
• azacitidine
Solution for subcutaneous injection or intravenous infusion
• venetoclax
Tablet for oral administration
• INQOVI (oral decitabine)
Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral)

Locations

Country	Name	City	State
Brazil	Novartis Investigative Site	Florianopolis	SC
China	Novartis Investigative Site	Chang Chun	Jilin
China	Novartis Investigative Site	Tianjin
Czechia	Novartis Investigative Site	Praha
Greece	Novartis Investigative Site	Alexandroupolis	Evros
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Roma	RM
Malaysia	Novartis Investigative Site	Kuala Lumpur
Spain	Novartis Investigative Site	Badalona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Madrid
Turkey	Novartis Investigative Site	Izmir
United States	Massachusetts General Hospital .	Boston	Massachusetts
United States	Oregon Health Sciences University Main Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Brazil,  China,  Czechia,  Greece,  Italy,  Malaysia,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Severity of AEs and SAEs	Severity of AEs and SAEs will be measured according to the CTCAE v5.0	5 years
Secondary	Duration of exposure to sabatolimab	The length of time patients will be exposed to sabatolimab and will be reported by treatment groups.	5 years