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.

Novartis

Status and phase: Active, not recruiting; Phase 2

Conditions: Leukemia, Myelomonocytic, Chronic; Myelodysplastic Syndromes

Treatments: Drug: sabatolimab; Drug: decitabine; Drug: venetoclax; Drug: spartalizumab; Drug: INQOVI (oral decitabine); Drug: azacitidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05201066

2024-515281-14-00 (Registry Identifier)

CMBG453B12206B

2021-004422-30 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 12 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 6 patient groups

sabatolimab + azacitidine

Experimental group

Description:

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.

Treatment:

Drug: azacitidine

Drug: sabatolimab

sabatolimab + decitabine

Experimental group

Description:

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

Treatment:

Drug: decitabine

Drug: sabatolimab

sabatolimab + venetoclax + azacitidine

Experimental group

Description:

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.

Treatment:

Drug: azacitidine

Drug: venetoclax

Drug: sabatolimab

sabatolimab + spartalizumab + decitabine

Experimental group

Description:

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.

Treatment:

Drug: spartalizumab

Drug: decitabine

Drug: sabatolimab

sabatolimab + HMA

Experimental group

Description:

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.

Treatment:

Drug: INQOVI (oral decitabine)

Drug: sabatolimab

sabatolimab

Experimental group

Description:

Patients will take sabatolimab 800 mg i.v q4w.

Treatment:

Drug: sabatolimab