A study of efficacy and safety of LAG525 in combination with spartalizumab, or with spartalizumab and carboplatin, or with carboplatin, in patients with advanced triple-negative breast cancer.
- Conditions
- triple negative breast cancerMedDRA version: 20.0Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-004865-28-BE
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 84
• Patient has advanced (loco-regionally recurrent not amenable to curative therapy or metastatic) breast
cancer.
• Patient must have measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (Tumor lesions
previously irradiated or subjected to other loco-regional therapy will only be considered measurable if disease progression at the treated site after completion of therapy is clearly documented)
• Patient progressed after adjuvant or 1 prior systemic treatment in the advanced setting. Patients with de novo metastatic disease are eligible if they received 1 prior line of therapy
• Patient must have received prior systemic treatment that included taxane-based chemotherapy for adjuvant or metastatic disease
• Patient must have a site of disease amenable to biopsy, and must be willing to undergo a new tumor biopsy at screening and during therapy on this study, the latter if medically feasible. Patients with an available archival tumor tissue do not need to perform a tumor biopsy at screening if patient has not received anti-cancer therapy since the biopsy was taken.
• Patient has histologically and/or cytologically confirmed diagnosis of advanced TNBC (based on most recently analyzed biopsy, from locally recurrent or metastatic site, local lab) meeting the following criteria: HER2 negative in situ hybridization test or an IHC status of 0 or 1+, and ER and PR expression is <1 percent as determined by immunohistochemistry (IHC)
Other protocol-defined inclusion criteria 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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 59
• Patient has received prior immune checkpoint inhibitors as anticancer treatment such as anti-LAG-3, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody (any line of therapy).
• Patient received prior neoadjuvant or adjuvant therapy with a platinum agent or mitomycin and experienced recurrence within 12
months after the end of the platinum-based or mitomycin containing therapy, or received platinum or mitomycin for advanced disease.
• Patient has had major surgery within 14 days prior to starting study treatment or has not recovered to grade 1 or less from major side effects.
• Patient with presence of CTCAE grade 2 toxicity or higher due to prior cancer therapy. Exception: Patients with any grade of alopecia are allowed to enter the study.
• Patient has received radiotherapy = 4 weeks prior to randomization (= 2 weeks for limited field radiation for palliation), and has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia).
• Patient has a known hypersensitivity to other monoclonal antibodies, platinumcontaining compounds, or to any of the excipients of LAG525, spartalizumab, or carboplatin.
• Patient with history or presence of central nervous system (CNS) metastases, treated or untreated.
Other protocol-defined exclusion criteria 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