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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Single-Arm Efficacy StudyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Objective

Overall survival (in months) of patients with advanced or metastatic rare malignancies and CPS ≥ 10 following disease progression after prior treatments while receiving the anti-PD1 antibody Nivolumab.

Time frame
2 years
2

Primary Endpoint

The primary outcome of the study is the disease control rate (DCR) based on imaging, considering the best response to treatment. A response rate of 5% will be considered non-promising, and a response rate of 25% will be considered promising. The study follows Simon's two-stage design, with type I error (alpha) set at 0.05 and type II error (beta) at 0.10. In the first stage, if at least 1 out of the first 9 participants achieves disease control (stable disease, partial response, or complete response), 16 additional participants will be recruited for the second stage. The study will be deemed positive if at least 3 out of 25 participants achieve disease control (partial response, complete response, or stable disease). A 10% drop-out rate (3 participants) is anticipated, bringing the maximum total recruitment to 28 participants.

Time frame
2 years

Secondary outcomes

1

Objective Response Rate (ORR)

Percentage of patients with a tumor size reduction, measured according to RECIST criteria.

Time frame
2 years
2

Subgroup Analysis Based on PD-L1 Expression and CPS:

PD-L1 Expression: Proportion of patients showing PD-L1 positivity. CPS Subgroups: Proportion of patients with CPS between 10-20 and those with CPS \> 20.

Time frame
2 years
3

Correlation of Clinical Outcomes with Biomarker Assessments

Microvesicle Analysis: Correlation between clinical outcomes and levels of circulating microvesicles. Serum Multiplex Panel: Correlation between clinical outcomes and serum biomarker levels (e.g., cytokines, chemokines), measured in concentration units (e.g., pg/mL).

Time frame
2 years
4

Overall Survival (OS)

Time from treatment initiation to death from any cause, measured in months.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto do Cancer do Estado de São Paulo

Lead sponsor

Financiadora de Estudos e Projetos

Collaborator

Source ClinicalTrials.gov
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