EUCTR2017-004865-28-BEActive, not recruitingPhase 1
A phase II open-label, randomized, three-arm, multicenter study of LAG525 given in combination with spartalizumab (PDR001), or with spartalizumab and carboplatin, or with carboplatin, as first or second line therapy in patients with advanced triple-negative breast cancer
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma AG
- Enrollment
- 84
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patient has advanced (loco-regionally recurrent not amenable to curative therapy or metastatic) breast
- •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
Exclusion Criteria
- •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
Investigators
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