Agnostic Therapy in Rare Solid Tumors

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

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
• Adenoid Cystic Carcinoma
• Mesothelioma
• Neuroblastoma
• Adrenal Gland Neoplasms
• Penile Neoplasms
• Apocrine Carcinoma
• Fibrosarcoma
• Cancer of Unknown Primary
• Hemangioblastoma
• Thyroid Neoplasms
• Hepatoblastoma
• Fallopian Tube Neoplasms
• Leiomyosarcoma
• Vaginal Neoplasms
• Neurofibrosarcoma
• Gallbladder Neoplasms
• Osteosarcoma
• Biliary Tract Neoplasms
• Clear Cell Endometrial Cancer
• Yolk Sac Tumor
• Vulvar Neoplasms
• Kaposi Sarcoma
• Ovarian Epithelial Cancer
• Soft Tissue Sarcoma
• Urethral Neoplasms
• Granulosa Cell Tumor
• Primitive Neuroectodermal Tumor
• Neuroendocrine Tumors
• Trophoblastic Tumor

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.

Sponsors & Collaborators

• Financiadora de Estudos e Projetos

  collaborator OTHER

• Instituto do Cancer do Estado de São Paulo

  lead OTHER

Principal Investigators

• Camila MV Moniz, Doctor · Oncologist

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-16

Primary Completion

2026-07-31

Completion

2028-05-31

Countries

• Brazil

Study Locations