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Agnostic Therapy in Rare Solid Tumors

Study acronym: ANTARES
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jul 2026 → Jul 2027
See other at-risk trials from Instituto do Cancer do Estado de São Paulo

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 2026 to Jul 2027 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Trial sites reduced: 8 → 5 locations
    • Eligibility criteria expanded, about 87 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Publications: details revised at 8 of 8 entries
  2. Trial status: Active, Not Recruiting to Recruiting
    • Start date: Jul 1, 2024 to Jul 16, 2024
    • Site details revised at 8 of 8 sites
    v3
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 8 of 8 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Instituto do Cancer do Estado de São Paulo
24 trials monitored
See 1 trial at risk
Breast Cancer
5,418 trials monitored
See 296 trials at risk
Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
Head & Neck Cancer
2,605 trials monitored
See 150 trials at risk
and 7 more diseases
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
Trial Details
NCT Number NCT06638931
Lead Sponsor Instituto do Cancer do Estado de São Paulo
Collaborators: Financiadora de Estudos e Projetos
Conditions
(from sponsor)		 Urachal Cancer, Parathyroid Carcinoma, Fibrolamellar Carcinoma, Angiosarcoma, Secretory Carcinoma of Breast, Anal Neoplasms, Metaplastic Breast Carcinoma, Translocation Renal Cell Carcinoma +33 more
Related terms Adrenal Gland Neoplasms, Anus Neoplasms, Biliary Tract Neoplasms, Carcinoma, Adenoid Cystic, Carcinoma, Ovarian Epithelial, Carcinosarcoma, Cholangiocarcinoma, Endodermal Sinus Tumor, Fallopian Tube Neoplasms, Fibrolamellar hepatocellular carcinoma, Fibrosarcoma, Gallbladder Neoplasms, Granulosa Cell Tumor, Hemangioblastoma, Hemangiosarcoma, Hepatoblastoma, Leiomyosarcoma, Mesothelioma, Neuroblastoma, Neuroectodermal Tumors, Primitive, Neuroendocrine Tumors, Neurofibrosarcoma, Osteosarcoma, Parathyroid Neoplasms, Penile Neoplasms, Sarcoma, Sarcoma, Kaposi, Secretory breast carcinoma, Sertoli-Leydig Cell Tumor, Thyroid Neoplasms, Trophoblastic Neoplasms, Urachal adenocarcinoma, Urachal cancer, Urethral Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov