Health Trials

Agnostic Therapy in Rare Solid Tumors

ConditionsUrachal CancerParathyroid CarcinomaFibrolamellar CarcinomaAngiosarcomaSecretory Carcinoma of BreastAnal NeoplasmsMetaplastic Breast CarcinomaTranslocation Renal Cell CarcinomaCarcinosarcomaSmall Intestine NeoplasmsCholangiocarcinomaSertoli-Leydig Cell TumorAdenoid Cystic CarcinomaMesotheliomaNeuroblastomaAdrenal Gland NeoplasmsPenile NeoplasmsApocrine CarcinomaFibrosarcomaCancer of Unknown PrimaryHemangioblastomaThyroid NeoplasmsHepatoblastomaFallopian Tube NeoplasmsLeiomyosarcomaVaginal NeoplasmsNeurofibrosarcomaGallbladder NeoplasmsOsteosarcomaBiliary Tract NeoplasmsClear Cell Endometrial CancerYolk Sac TumorVulvar NeoplasmsKaposi SarcomaOvarian Epithelial CancerSoft Tissue SarcomaUrethral NeoplasmsGranulosa Cell TumorPrimitive Neuroectodermal TumorNeuroendocrine TumorsTrophoblastic Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto do Cancer do Estado de São Paulo

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

Previous treatment lines with immunotherapy (immune checkpoint inhibitors).

Pregnant or breastfeeding individuals.

Limiting comorbidity, in the opinion of the investigator.

Active infection.

Trial design

Treatments tested in this trial

  • Nivolumab

Treatment groups

28 Participants
are divided into 1 treatment group

Sponsors and collaborators

Instituto do Cancer do Estado de São Paulo

Lead sponsor

Financiadora de Estudos e Projetos

Collaborator

Source ClinicalTrials.gov