A study of sabatolimab in combination with azacitidine and venetoclax in high or very high risk MDS participants

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 76

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study
2. Age = 18 years at the date of signing the informed consent form (ICF)
3. Morphologically confirmed diagnosis of myelodysplastic syndrome (MDS)
based on 2016 WHO classification by local investigator assessment with one of the following Prognostic Risk Categories, based on the revised International Prognostic Scoring System (IPSS-R):
? Very high (> 6 points)
? High (> 4.5-6 points)
4. Not immediately eligible for hematopoietic stem-cell transplantation (HSCT) or intensive chemotherapy at the time of screening due to individual clinical factors such as age, comorbidities and performance status, donor availability
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Additional inclusion criteria as per full protocol may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 53

Exclusion Criteria

1. Prior exposure to TIM-3 directed therapy or any BCL-2 inhibitor (including
venetoclax) at any time
2. Prior therapy with immune check point inhibitors (e.g. anti-CTLA4, anti-
PD-1, anti-PD-L1, or anti-PD-L2) or cancer vaccines is not allowed if the last
dose of the drug was administered within 4 months prior to start of treatment
3. Previous first-line treatment for very high risk or high risk myelodysplastic syndromes (based on IPSS-R) with any antineoplastic agents, approved or
investigational, including for example chemotherapy, lenalidomide and
hypomethylating agents (HMAs) such as decitabine or azacitidine. However, a one single cycle of HMAs treatment only started prior to enrollment is allowed.
4. Live vaccine administered within 30 days prior to start of treatment
5. Current use or use within 14 days prior to start of treatment of systemic
steroid therapy (> 10 mg/day prednisone or equivalent) or any
immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are
allowed. Replacement therapy, steroids given in the context of a transfusion,
are allowed and not considered a form of systemic treatment
6. History of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, venetoclax or sabatolimab) or monoclonal antibodies (mAbs) and/or their excipients
7. Participants with Myelodysplastic syndrome (MDS) based on 2016 WHO
classification with revised International Prognostic Scoring System (IPSS-R) = 4.5

Other protocol-defined Inclusion/Exclusion may apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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