Agnostic Therapy in Rare Solid Tumors

Sponsor
Instituto do Cancer do Estado de São Paulo
Study ID
NCT06638931
Phase
PHASE2
Status
Recruiting
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Conditions

  • Adenoid Cystic Carcinoma
  • Adrenal Gland Neoplasms
  • Anal Neoplasms
  • Angiosarcoma
  • Apocrine Carcinoma
  • Biliary Tract Neoplasms
  • Cancer of Unknown Primary
  • Carcinosarcoma
  • Cholangiocarcinoma
  • Clear Cell Endometrial Cancer
  • Fallopian Tube Neoplasms
  • Fibrolamellar Carcinoma
  • Fibrosarcoma
  • Gallbladder Neoplasms
  • Granulosa Cell Tumor
  • Hemangioblastoma
  • Hepatoblastoma
  • Kaposi Sarcoma
  • Leiomyosarcoma
  • Mesothelioma
  • Metaplastic Breast Carcinoma
  • Neuroblastoma
  • Neuroendocrine Tumors
  • Neurofibrosarcoma
  • Osteosarcoma
  • Ovarian Epithelial Cancer
  • Parathyroid Carcinoma
  • Penile Neoplasms
  • Primitive Neuroectodermal Tumor
  • Secretory Carcinoma of Breast
  • Sertoli-Leydig Cell Tumor
  • Small Intestine Neoplasms
  • Soft Tissue Sarcoma
  • Thyroid Neoplasms
  • Translocation Renal Cell Carcinoma
  • Trophoblastic Tumor
  • Urachal Cancer
  • Urethral Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms
  • Yolk Sac Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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.

Study Details

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

Key Dates

Start date
Jul 16, 2024
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
May 31, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single-Arm Efficacy Study
    Treatment will be administered with intravenous nivolumab at a dose of 480 mg every 4 weeks. Treatment will continue until limiting toxicity, disease progression, or for a maximum of 12 months as maintenance if the individual achieves stable disease, partial response, or complete response.

Primary Outcome Measure

Primary Objective [ Time Frame: 2 years ]

Central Contacts

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