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ACTIVE NOT RECRUITING
NCT06638931
PHASE2

Agnostic Therapy in Rare Solid Tumors

Sponsor: Instituto do Cancer do Estado de São Paulo

View on ClinicalTrials.gov

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

Interventions

DRUG

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