A Phase II efficacy and safety study of MBG453 in combination with hypomethylating agents in subjects with IPSS-R intermediate, high or very high risk myelodysplastic syndrome (MDS).
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]Adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteriaMedDRA version: 20.0Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851
- Registration Number
- EUCTR2018-004479-11-IT
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
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 a myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber et al 2016) by investigator assessment with one of the following Prognostic Risk Categories, based on the International Prognostic Scoring System (IPSS-R):
• Very high (> 6 points)
• High (> 4.5-6 points)
• Intermediate (> 3-4.5 points): a subject determined to be in the Intermediate Prognostic Risk Category is only allowable in the setting of = 5% bone marrow blast
4. Not eligible at the time of screening, for intensive chemotherapy
according to the investigator, based on local standard medical practice
and institutional guidelines for treatment decisions.
5. Not eligible at the time of screening, for hematopoietic stem-cell
transplantation (HSCT) according to the investigator, based on local
standard medical practice and institutional guidelines for treatment
decisions.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Refer to protocol for complete list of inclusion criteria.
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 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84
1. Prior exposure to TIM-3 directed therapy at any time. Prior therapy
with immune check point inhibitors (e.g. anti-CTLA4, anti-PD-1, anti-PD
L1,
or anti-PD-L2), cancer vaccines are allowed except if the drug was
administered within 4 months prior to randomization.
2. Previous first-line treatment for intermediate, high or very high risk
myelodysplastic syndromes (based on IPSS-R) with chemotherapy or
any other antineoplastic agents including lenalidomide and
hypomethylating agent (HMAs) such as decitabine or azacitidine.
3. History of severe hypersensitivity reactions to any ingredient of the
study treatment (azacitidine, decitabine or MGB453) or their excipients,
or to monoclonal antibodies (mAbs).
4. Currently using or used within 14 days prior to randomization 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.
5. Investigational treatment for MDS received within 4 weeks prior to randomization. In case of a checkpoint inhibitor: 4 months minimum prior to randomization interval is necessary to allow enrollment.
6. Active autoimmune disease requiring systemic therapy (e.g. corticosteroids).
7. Live vaccine administered within 30 days prior to randomization.
Refer to protocol for complete list of exclusion criteria.
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