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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Agnostic Therapy in Rare Solid Tumors

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

Agnostic Therapy in Rare Solid Tumors (NCT06638931) is a Phase 2 interventional studying Urachal Cancer and Parathyroid Carcinoma, sponsored by Instituto do Cancer do Estado de São Paulo. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Urachal Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 28 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Inclusion Criteria 1. Age 18 years or older. 2. Patients with immunohistochemistry for PD-L1 with a combined positive score (CPS) of 10 or higher. 3. Patients with progression or intolerance to already approved and accessible treatments for the specific neoplasm and population. 4. Documented disease progression radiologically after the last routine treatment. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Measurable lesion per RECIST v1.1. Lesions previously treated with radiotherapy can only be used as target lesions if they are confirmed to be progressing by imaging before enrollment. 7. Male participants must meet at least one of the following conditions: 1. Considered infertile; 2. No fertile partner; 3. Has a fertile partner who agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab; and 4. Agrees to abstain from sperm donation throughout the study period and for at least 6 months after the last dose of Nivolumab. 8. Female participants must meet at least one of the following conditions: 1. Considered infertile; 2. Agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab; 9. Estimated expected to live at least 12 weeks, as determined by the investigator or delegated sub-investigator. 10. Preserved organ functions defined by: - Absolute neutrophil count ≥ 1,000; - blood count (hemoglobin) at least 8.0 g/dL (patients may receive transfusions to reach this level); - Platelet count ≥ 100,000; - Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), or ≤ 3.0 × ULN for patients with Gilbert's syndrome; - Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases); - Creatinine clearance \> 30 mL/min (estimated by Cockcroft-Gault). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria 1. Age 18 years or older. 2. Patients with immunohistochemistry for PD-L1 with a combined positive score (CPS) of 10 or higher. 3. Patients with progression or intolerance to already approved and accessible treatments for the specific neoplasm and population. 4. Documented disease progression radiologically after the last routine treatment. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Measurable lesion per RECIST v1.1. Lesions previously treated with radiotherapy can only be used as target lesions if they are confirmed to be progressing by imaging before enrollment. 7. Male participants must meet at least one of the following conditions: 1. Considered infertile; 2. No fertile partner; 3. Has a fertile partner who agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab; and 4. Agrees to abstain from sperm donation throughout the study period and for at least 6 months after the last dose of Nivolumab. 8. Female participants must meet at least one of the following conditions: 1. Considered infertile; 2. Agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab; 9. Estimated life expectancy greater than 12 weeks, as determined by the investigator or delegated sub-investigator. 10. Preserved organ functions defined by: * Absolute neutrophil count ≥ 1,000; * Hemoglobin ≥ 8.0 g/dL (patients may receive transfusions to reach this level); * Platelet count ≥ 100,000; * Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), or ≤ 3.0 × ULN for patients with Gilbert's syndrome; * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases); * Creatinine clearance \> 30 mL/min (estimated by Cockcroft-Gault). 11. Diagnosis of rare cancer (List I) confirmed by histopathological examination, with the possibility of including other types of rare tumors (incidence of less than 6 in every 100,000) after careful evaluation and approval by the study board. * List I: * Urachal adenocarcinoma * Parathyroid carcinoma * Nasopharyngeal epithelial tumors * Fibrolamellar carcinoma of any primary site * Angiosarcoma of any primary site * Secretory breast carcinoma * Anal cancer * Metaplastic breast carcinoma * Chromophobe renal carcinoma, Microphthalmia-associated Transcription Factor (MiT) family translocation renal carcinoma; renal carcinoma with Fumarate Hydratase (FH) or Succinate Dehydrogenase (SDH) deficiency * Carcinosarcoma of any primary site * Small intestine cancer * Cholangiocarcinoma * Sertoli-Leydig cell tumors * Cervical cancer of non-epidermoid histology * Tracheal epithelial tumors * Non-cystadenoma salivary gland tumors * Mesothelioma of any site * Neuroblastoma * Adrenal cancer * Penile cancer * Apocrine carcinoma * Fibrosarcoma of any primary site * Cancer of unknown primary site * Hemangioblastoma of any primary site * Thyroid cancer * Hepatoblastoma * Fallopian tube cancer * Leiomyosarcoma of any primary site * Vaginal cancer * Neurofibrosarcoma of any primary site * Gallbladder cancer * Osteosarcoma of any primary site * Bile duct cancer * Clear cell endometrial carcinoma * Yolk sac tumor of any primary site * Non-epidermoid bladder cancer * Vulvar cancer * Kaposi's sarcoma * Epithelial ovarian cancer * Soft tissue sarcoma * Urethral cancer * Granulosa cell tumor of any primary site * Cystadenoma carcinoma * Primitive neuroectodermal tumor of any primary site * Pure or mixed neuroendocrine tumors with neuroendocrine component * Trophoblastic tumor Exclusion Criteria 1. Previous treatment lines with immunotherapy (immune checkpoint inhibitors). 2. Pregnant or breastfeeding individuals. 3. Limiting comorbidity, in the opinion of the investigator. 4. Active infection. 5. Major surgery within the last 4 weeks. 6. Functional class II or greater heart failure. 7. Myocardial infarction or stroke within the last 6 months. 8. History of pulmonary fibrosis or pneumonitis. 9. Autoimmune diseases, except for patients with vitiligo and/or controlled thyroid/hypothyroidism without the use of immunosuppressors. 10. Second invasive primary tumor diagnosed in the last 3 years and/or with active disease, except for localized skin tumors (non-melanoma) that have been treated with curative intent. 11. Patients with prolonged QT interval. 12. Uncontrolled Central Nervous System (CNS) metastases. Patients who have previously received local treatment, such as radiotherapy, will be eligible if clinical and radiological stability is demonstrated in the 2 weeks prior to the start of treatment. Patients must not be using corticosteroids for managing CNS disease. 13. Presence of meningeal carcinomatosis. 14. Worsening renal and liver function in the 14 days prior to enrollment. 15. History of solid organ transplantation with or without immunosuppression. 16. Patients with untreated acquired immunodeficiency. Immunocompromised patients may be included as long as they do not have active opportunistic disease and/or active infection, after thorough clinical evaluation by the investigator or sub-investigator. HIV-positive patients must have documented undetectable viral load prior to inclusion. 17. Chronic use of corticosteroids at doses greater than 10 mg/day of prednisone or equivalent. Patients with adrenal insufficiency of non-autoimmune etiology (e.g., previous bilateral adrenalectomy) may be included if they are clinically compensated with 10 mg/day of prednisone or equivalent or less.

Treatments Being Tested

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.

Locations (8)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hospital São Carlos
Fortaleza, Ceará, Brazil
Hospital São Rafael
Salvador, Estado de Bahia, Brazil
Hospital Santa Cruz
Curitiba, Paraná, Brazil
IDOR Recife
Recife, Pernambuco, Brazil
Instituto D'or de Pesquisa e Ensino
São Paulo, São Paulo, Brazil
Instituto do Câncer do Estado de São Paulo - ICESP
São Paulo, São Paulo, Brazil
DF Star
Brasília, Brazil
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, Brazil

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06638931), the sponsor (Instituto do Cancer do Estado de São Paulo), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06638931 clinical trial studying?

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 ef… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06638931?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06638931?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06638931. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06638931. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.