Myelodysplastic SyndromesPhase 2NCT05201066
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.
A Phase 2 study testing decitabine, spartalizumab and sabatolimab in people with Myelodysplastic Syndromes and Leukemia, Myelomonocytic, Chronic, run by Novartis Pharmaceuticals at 24 sites in 15 countries.
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. Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
- What is being tested?
- decitabine, spartalizumab and sabatolimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 24 sitesin 15 countries
- Study dates
- 28 Feb 2023to 14 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Other protocol-defined Inclusion/Exclusion may apply.
Trial locations and contacts
24 sites in 15 countries.
24 sites in 15 countries
Italy5 sites
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Roma, RM, 00133
Spain3 sites
Novartis Investigative Site
Badalona, Barcelona, 08916
Novartis Investigative Site
Barcelona, 08036
Novartis Investigative Site
Madrid, 28009
United States2 sites
Oregon Health Sciences University
Portland, Oregon, 97239
Huntsman Cancer Institute Univ of Utah
Salt Lake City, Utah, 84112-0550
China2 sites
Novartis Investigative Site
Changchun, Jilin, 130021
Novartis Investigative Site
Tianjin, 300020
Greece2 sites
Novartis Investigative Site
Alexandroupoli, 681 00
Novartis Investigative Site
Pátrai, 265 04
Brazil1 site
Novartis Investigative Site
Florianópolis, Santa Catarina, 88020-210
Germany1 site
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
About this study
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.
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.
Read the 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.
- Being tested
- decitabine, spartalizumab, sabatolimab, azacitidine, venetoclax
- Keywords
- roll-over study, MBG453, sabatolimab, azacitidine, decitabine, venetoclax, spartalizumab, HMA, INQOVI (oral decitabine)
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decitabineDrug
Solution for intravenous infusion
spartalizumabDrug
Also called PDR001
Solution for intravenous infusion
sabatolimabDrug
Also called MBG453
Solution for intravenous infusion
azacitidineDrug
Solution for subcutaneous injection or intravenous infusion
venetoclaxDrug
Tablet for oral administration
INQOVI (oral decitabine)Drug
Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral)
| Study group | Role | What they receive |
|---|---|---|
| sabatolimab + azacitidine | Experimental | 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. Receives: Drug: sabatolimab; Drug: azacitidine |
| sabatolimab + decitabine | Experimental | Patients will take Sabatolimab 400 mg i.v/q2w and decitabine 20 mg/m2/d d1-5 i.v. Receives: Drug: decitabine; Drug: sabatolimab |
| sabatolimab + venetoclax + azacitidine | Experimental | 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. Receives: Drug: sabatolimab; Drug: azacitidine; Drug: venetoclax |
| sabatolimab + spartalizumab + decitabine | Experimental | 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. Receives: Drug: decitabine; Drug: spartalizumab; Drug: sabatolimab |
| sabatolimab + HMA | Experimental | 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. Receives: Drug: sabatolimab; Drug: INQOVI (oral decitabine) |
| sabatolimab | Experimental | Patients will take sabatolimab 800 mg i.v q4w. Receives: Drug: sabatolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Severity of AEs and SAEs
Severity of AEs and SAEs will be measured according to the CTCAE v5.0
Measured: 5 years
Secondary outcomes (1)
Duration of exposure to sabatolimab
The length of time patients will be exposed to sabatolimab and will be reported by treatment groups.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start28 Feb 2023
- Primary completion14 Feb 2028 (estimated)
- Study completion14 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201066
- Sponsor's protocol ID
- CMBG453B12206B
- Other IDs
- 2021-004422-30, 2024-515281-14-00
- Status last verified
- Sep 2026
- First submitted
- 3 Jan 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05201066
- Acronym / sponsor ID
- CMBG453B12206B
- Keywords
- roll-over study, MBG453, sabatolimab, azacitidine, decitabine, venetoclax, spartalizumab, HMA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 14 Feb 2028 (estimated)
- Study completion
- 14 Feb 2028 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| sabatolimab + azacitidine | Experimental | Drug: sabatolimab, Drug: azacitidinePatients 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. |
| sabatolimab + decitabine | Experimental | Drug: decitabine, Drug: sabatolimabPatients will take Sabatolimab 400 mg i.v/q2w and decitabine 20 mg/m2/d d1-5 i.v. |
| sabatolimab + venetoclax + azacitidine | Experimental | Drug: sabatolimab, Drug: azacitidine, Drug: venetoclaxPatients 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. |
| sabatolimab + spartalizumab + decitabine | Experimental | Drug: decitabine, Drug: spartalizumab, Drug: sabatolimabPatients 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. |
| sabatolimab + HMA | Experimental | Drug: sabatolimab, Drug: INQOVI (oral decitabine)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. |
| sabatolimab | Experimental | Drug: sabatolimabPatients will take sabatolimab 800 mg i.v q4w. |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decitabineSolution for intravenous infusion | Drug | sabatolimab + decitabine, sabatolimab + spartalizumab + decitabine |
| spartalizumabAlso: PDR001Solution for intravenous infusion | Drug | sabatolimab + spartalizumab + decitabine |
| sabatolimabAlso: MBG453Solution for intravenous infusion | Drug | sabatolimab, sabatolimab + HMA, sabatolimab + azacitidine, sabatolimab + decitabine, sabatolimab + spartalizumab + decitabine, sabatolimab + venetoclax + azacitidine |
| azacitidineSolution for subcutaneous injection or intravenous infusion | Drug | sabatolimab + azacitidine, sabatolimab + venetoclax + azacitidine |
| venetoclaxTablet for oral administration | Drug | sabatolimab + venetoclax + azacitidine |
| INQOVI (oral decitabine)Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral) | Drug | sabatolimab + HMA |
Primary outcome
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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
Time frame: 5 years
Severity of AEs and SAEs will be measured according to the CTCAE v5.0
1 secondary outcome
Duration of exposure to sabatolimab
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
24 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing decitabine, spartalizumab and sabatolimab in people with Myelodysplastic Syndromes and Leukemia, Myelomonocytic, Chronic, run by Novartis Pharmaceuticals at 24 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy, Spain, United States, China, Greece and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.