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Agnostic Therapy in Rare Solid Tumors
Sponsor: Instituto do Cancer do Estado de São Paulo
Summary
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
Official title: Phase II Basket Study to Evaluate the Tissue-agnostic Efficacy of Anti-Programmed Cell Death Protein 1 (Anti-PD1) Monoclonal Antibody in Patients With Advanced Rare Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2024-07-01
Completion Date
2028-05
Last Updated
2025-05-28
Healthy Volunteers
No
Conditions
Interventions
Nivolumab
The intervention consists of administering Nivolumab 480 mg intravenously every 4 weeks, with a +5 day window for postponement but not for advancement of treatment. Treatment will continue until limiting toxicity, disease progression, or for a maximum period of 12 months (13 cycles) as maintenance therapy, provided the patient maintains stable disease, a partial response, or a complete response. Patients who are off treatment for more than 56 days (2 cycles) due to Nivolumab-related toxicities or other clinical issues will be discontinued from the protocol. After 12 months of treatment or in the event of study discontinuation for any reason, patients will be followed by the research team via telephone every 60 days, with a +/- 7 day window, until death.
Locations (8)
DF Star
Brasília, Brasília, Brazil
Hospital São Carlos
Fortaleza, Ceará, Brazil
Hospital São Rafael
Salvador, Estado de Bahia, Brazil
Hospital Santa Cruz
Curitiba, Paraná, Brazil
IDOR Recife
Recife, Pernambuco, Brazil
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, Rio de Janeiro, Brazil
Instituto D'or de Pesquisa e Ensino
São Paulo, São Paulo, Brazil
Instituto do Câncer do Estado de São Paulo - ICESP
São Paulo, São Paulo, Brazil