The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.
The study aims to treat rare malignancies with PD-L1 expression (CPS ≥ 10), regardless of the tumor's tissue type or location. Patients who have not responded to standard treatments will be included, and treatment will last for up to 12 months. The study will assess objective response, progression-free survival, and biomarkers such as PD-L1, ctDNA, and microvesicles, in a multicenter collaborative effort to provide innovative therapeutic options for this underrepresented population
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 years or older.
✓. Patients with immunohistochemistry for PD-L1 with a combined positive score (CPS) of 10 or higher.
✓. Patients with progression or intolerance to already approved and accessible treatments for the specific neoplasm and population.
✓. Documented disease progression radiologically after the last routine treatment.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Measurable lesion per RECIST v1.1. Lesions previously treated with radiotherapy can only be used as target lesions if they are confirmed to be progressing by imaging before enrollment.
✓. Male participants must meet at least one of the following conditions:
✓. Considered infertile;
Exclusion criteria
✕. Previous treatment lines with immunotherapy (immune checkpoint inhibitors).
What they're measuring
1
Primary Objective
Timeframe: 2 years
2
Primary Endpoint
Timeframe: 2 years
Trial details
NCT IDNCT06638931
SponsorInstituto do Cancer do Estado de São Paulo