Triple negative breast cancer
Conditions
Interventions
Arm 1: Spartalizumab + LAG525 in combination with NIR178
Arm 2: Spartalizumab + LAG525 in combination with capmatinib
Arm 3: Spartalizumab + LAG525 in combination with MCS110
Arm 4: Spartalizumab + LA
Sponsors
Novartis Pharma KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with advanced/metastatic TNBC (defined as HER-2 negative with under 1% of tumor cell nuclei immunoreactive for estrogen receptor (ER) and progesterone receptor (PR), with measurable disease as determined by RECIST version 1.1. Patients should have documented disease progression following, or intolerance to, no more than 2 prior lines of chemotherapy for advanced or metastatic disease. Neoadjuvant and/or adjuvant chemotherapy administered with curative intent will count as one prior line of therapy, if disease recurred within 12 months of the last treatment. Patients must have received prior systemic treatment that included taxane-based chemotherapy for (neo)adjuvant or metastatic disease. Patients must have a site of disease amenable to core needle biopsy, and be a candidate for tumor biopsy according to the treating institutions guidelines.
Exclusion criteria
Exclusion criteria: Patients with a history of treatment with anti-LAG-3, anti-PD-1, anti-PD-L1 or anti-PD-L2 antibodies. Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy. History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients. Impaired cardiac function or clinically significant cardiac disease. HIV infection. Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. For patients with inactive HBV or HCV infection (hepatitis controlled under antiviral therapy), see study drug-specific exclusion criteria. For dose expansion, patients whose disease is controlled under antiviral therapy should not be excluded. Active, known or suspected autoimmune disease. History of or current interstitial lung disease or pneumonitis over grade 2. Subjects with tuberculosis (TB) (patients receiving MCS110 or canakinumab)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Incidence and severity of AEs and SAEs,Incidence and nature of DLTs in first cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics Best overall response (BOR) and PFS per RECIST. | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania
Contacts
Public ContactMasataka Yonemura
Novartis Pharma. K.K.
Outcome results
None listed