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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004422-30 | EudraCT Number | ||
| 2024-515281-14-00 | Registry Identifier | EU CTIS |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| sabatolimab + decitabine | Experimental | Patients will take Sabatolimab 400 mg i.v/q2w and decitabine 20 mg/m2/d d1-5 i.v. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| decitabine | Drug | Solution for intravenous infusion |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States | ||
| Huntsman Cancer Institute Univ of Utah |
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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Open Label
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|
| sabatolimab | Experimental | Patients will take sabatolimab 800 mg i.v q4w. |
|
| spartalizumab | Drug | Solution for intravenous infusion |
|
|
| sabatolimab | Drug | Solution for intravenous infusion |
|
|
| azacitidine | Drug | Solution for subcutaneous injection or intravenous infusion |
|
| venetoclax | Drug | Tablet for oral administration |
|
| INQOVI (oral decitabine) | Drug | Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral) |
|
| Salt Lake City |
| Utah |
| 84112 0550 |
| United States |
| Novartis Investigative Site | Clayton | Victoria | 3168 | Australia |
| Novartis Investigative Site | Florianópolis | Santa Catarina | 88020-210 | Brazil |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Novartis Investigative Site | Changchun | Jilin | 130021 | China |
| Novartis Investigative Site | Tianjin | 300020 | China |
| Novartis Investigative Site | Prague | 128 08 | Czechia |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Novartis Investigative Site | Alexandroupoli | 681 00 | Greece |
| Novartis Investigative Site | Pátrai | 265 04 | Greece |
| Novartis Investigative Site | Brescia | BS | 25123 | Italy |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Genova | GE | 16132 | Italy |
| Novartis Investigative Site | Milan | MI | 20162 | Italy |
| Novartis Investigative Site | Roma | RM | 00133 | Italy |
| Novartis Investigative Site | Fukushima | 960 1295 | Japan |
| Novartis Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Badalona | Barcelona | 08916 | Spain |
| Novartis Investigative Site | Barcelona | 08036 | Spain |
| Novartis Investigative Site | Madrid | 28009 | Spain |
| Novartis Investigative Site | Zurich | 8091 | Switzerland |
| Novartis Investigative Site | Izmir | 35100 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| C000711728 | spartalizumab |
| C000723550 | sabatolimab |
| D001374 | Azacitidine |
| C579720 | venetoclax |
| C000723076 | decitabine and cedazuridine drug combination |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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