Phase 2Active, not recruiting

Agnostic Therapy in Rare Solid Tumors (ANTARES)

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

Sponsor
Instituto do Cancer do Estado de São Paulo (Academic or other)
Enrollment
28 planned
Conditions
Urachal Cancer; Parathyroid Carcinoma; Fibrolamellar Carcinoma; Angiosarcoma; Secretory Carcinoma of Breast; Anal Neoplasms; Metaplastic Breast Carcinoma; Translocation Renal Cell Carcinoma; Carcinosarcoma; Small Intestine Neoplasms; Cholangiocarcinoma; Sertoli-Leydig Cell Tumor
Interventions
Nivolumab
Ages
adults, older adults
Registry
NCT06638931

Full record on ClinicalTrials.gov

From the registry

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

Primary outcomes

  • Primary Objective
  • Primary Endpoint

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Registered

  5. Started