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Urachal CancerPhase 2ANTARESNCT06638931

Agnostic Therapy in Rare Solid Tumors

A Phase 2 study testing Nivolumab in people with Urachal Cancer and Parathyroid Carcinoma, run by Instituto do Cancer do Estado de São Paulo at 5 sites in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
5 sitesBrazil
Study dates
16 Jul 2024to May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • 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.
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  • Male participants must meet at least one of the following conditions:
  • Considered infertile;
  • No fertile partner;
  • 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
  • Agrees to abstain from sperm donation throughout the study period and for at least 6 months after the last dose of Nivolumab.
  • Female participants must meet at least one of the following conditions:
  • Considered infertile;
  • Agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;
  • Estimated life expectancy greater than 12 weeks, as determined by the investigator or delegated sub-investigator.
  • 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).
  • 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

Who cannot join

  • Previous treatment lines with immunotherapy (immune checkpoint inhibitors).
  • Pregnant or breastfeeding individuals.
  • Limiting comorbidity, in the opinion of the investigator.
  • Active infection.
  • Major surgery within the last 4 weeks.
  • Functional class II or greater heart failure.
Show all 17Show fewer
  • Myocardial infarction or stroke within the last 6 months.
  • History of pulmonary fibrosis or pneumonitis.
  • Autoimmune diseases, except for patients with vitiligo and/or controlled thyroid/hypothyroidism without the use of immunosuppressors.
  • 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.
  • Patients with prolonged QT interval.
  • 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.
  • Presence of meningeal carcinomatosis.
  • Worsening renal and liver function in the 14 days prior to enrollment.
  • History of solid organ transplantation with or without immunosuppression.
  • 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.
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Brazil5 sites

  • DF Star

    Brasília, 70390-903

  • IDOR Recife

    Recife, Pernambuco, 52010-010

  • Instituto D'Or de Pesquisa e Ensino

    Rio de Janeiro, 22281-100

  • Instituto D'or de Pesquisa e Ensino

    São Paulo, São Paulo, 04.501-000

  • Instituto do Câncer do Estado de São Paulo - ICESP

    São Paulo, São Paulo, 05403-010

Other trials in Brazil

About this study

Official title: 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

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

Read the detailed description

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. A "basket" trial is an innovative type of clinical trial where patients with different types of cancers, but sharing a common molecular feature (in this case, PD-L1 expression), are treated with the same therapy, regardless of the tumor's site of origin. This approach allows for the evaluation of treatments targeting specific molecular characteristics, independent of the primary cancer type.

Rare tumors, as defined by the World Health Organization (WHO), have an incidence of fewer than six cases per 100,000 people per year. Although each rare cancer type is individually uncommon, collectively they account for 25-30% of all malignancies and are often underrepresented in clinical trials due to recruitment challenges and limited funding. As a result, patients with rare cancers generally have a poorer prognosis compared to those with more common tumors.

In this study, patients with advanced or refractory rare malignancies expressing PD-L1, with a combined positive score (CPS) of ≥10, will be treated with nivolumab. Treatment will be administered until disease progression or for a maximum duration of 12 months, aiming to assess the efficacy and safety of this tissue-agnostic immunotherapy approach. Efficacy will be measured according to RECIST v1.1 criteria, with objective response as the primary endpoint. Additionally, the study will assess response biomarkers, including PD-L1, circulating tumor DNA (ctDNA), and microvesicles, to better understand the correlation between biomarker expression and clinical outcomes.

This multicenter trial, with an estimated duration of four years, will be conducted at Institute of Cancer of the State of São Paulo (ICESP) and other partner institutions. The study aims to overcome existing barriers in rare cancer treatment by offering an innovative approach that explores the potential of personalized therapies based on molecular characteristics, rather than the tumor's primary site

Being tested
Nivolumab
Keywords
Urachal Adenocarcinoma, Parathyroid Carcinoma, Nasopharyngeal Epithelial Tumors, Fibrolamellar Carcinoma, Angiosarcoma, Secretory Breast Carcinoma, Anal Cancer, Metaplastic Breast Carcinoma, Chromophobe Renal Carcinoma, Carcinosarcoma, Small Intestine Cancer, Cholangiocarcinoma, Sertoli-Leydig Cell Tumors, Non-Squamous Cervical Neoplasm, Tracheal Epithelial Tumors, Non-Adenoid Cystic Salivary Tumors, Mesothelioma, Neuroblastoma, Adrenal Neoplasm, Penile Cancer
Medical subject headings
Urachal cancer, Parathyroid Neoplasms, Fibrolamellar hepatocellular carcinoma, Hemangiosarcoma, Secretory breast carcinoma, Anus Neoplasms, Carcinosarcoma, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    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 groups in NCT06638931
Study groupRoleWhat they receive
Single-Arm Efficacy StudyExperimentalTreatment 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.
Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 2 years

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

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

    Measured: 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.

    Measured: 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).

    Measured: 2 years

  4. Overall Survival (OS)

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

    Measured: 2 years

  5. Progression-Free Survival (PFS)

    Time from treatment initiation to disease progression or death, whichever occurs first, measured in months.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start16 Jul 2024
  3. Primary completionJul 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study aims to evaluate the efficacy of the anti-PD1 monoclonal antibody, nivolumab, in the treatment of patients with advanced or metastatic rare malignant neoplasms. This study will be conducted as a single-arm trial, including patients who have a Combined Positive Score (CPS) of 10 or greater and who have demonstrated progression on standard treatment. Participants will be monitored to determine their response to treatment and any adverse effects associated with the use of nivolumab. The expectation is to provide evidence regarding the efficacy of this immunotherapeutic agent in a difficult-to-treat population, contributing to the advancement of therapeutic options available for these patients.
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06638931
Sponsor's protocol ID
NP4021/2023
Other IDs
68590423.0.1001.0068, 01.23.0265.00
Acronym
ANTARES
Status last verified
Oct 2026
First submitted
3 Oct 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It has been decided not to share individual participant data (IPD) related to the study for several reasons. Protecting the privacy of participants is a priority. Sharing IPD may expose sensitive information that, even when de-identified, can be traced back to individuals. Furthermore, the complexity of the data makes sharing challenging without the risk of misunderstandings or misinterpretations, which could compromise the integrity of the research. Sharing IPD without the explicit consent of participants may violate ethical principles of respect and protection. There is also a need to comply with regulatory guidelines governing data sharing to avoid potential legal issues. Finally, the focus will be on disseminating aggregated results that can benefit the scientific community and the public without compromising individual privacy.

Publications

  • Bogaerts J, Sydes MR, Keat N, McConnell A, Benson A, Ho A, Roth A, Fortpied C, Eng C, Peckitt C, Coens C, Pettaway C, Arnold D, Hall E, Marshall E, Sclafani F, Hatcher H, Earl H, Ray-Coquard I, Paul J, Blay JY, Whelan J, Panageas K, Wheatley K, Harrington K, Licitra L, Billingham L, Hensley M, McCabe M, Patel PM, Carvajal R, Wilson R, Glynne-Jones R, McWilliams R, Leyvraz S, Rao S, Nicholson S, Filiaci V, Negrouk A, Lacombe D, Dupont E, Pauporte I, Welch JJ, Law K, Trimble T, Seymour M. Clinical trial designs for rare diseases: studies developed and discussed by the International Rare Cancers Initiative. Eur J Cancer. 2015 Feb;51(3):271-81. doi: 10.1016/j.ejca.2014.10.027. Epub 2014 Dec 24.

    PubMed 25542058

  • Cortes J, Kim SB, Chung WP, Im SA, Park YH, Hegg R, Kim MH, Tseng LM, Petry V, Chung CF, Iwata H, Hamilton E, Curigliano G, Xu B, Huang CS, Kim JH, Chiu JWY, Pedrini JL, Lee C, Liu Y, Cathcart J, Bako E, Verma S, Hurvitz SA; DESTINY-Breast03 Trial Investigators. Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer. N Engl J Med. 2022 Mar 24;386(12):1143-1154. doi: 10.1056/NEJMoa2115022.

    PubMed 35320644

  • DuBois SG, Laetsch TW, Federman N, Turpin BK, Albert CM, Nagasubramanian R, Anderson ME, Davis JL, Qamoos HE, Reynolds ME, Cruickshank S, Cox MC, Hawkins DS, Mascarenhas L, Pappo AS. The use of neoadjuvant larotrectinib in the management of children with locally advanced TRK fusion sarcomas. Cancer. 2018 Nov 1;124(21):4241-4247. doi: 10.1002/cncr.31701. Epub 2018 Sep 11.

    PubMed 30204247

  • Le DT, Uram JN, Wang H, Bartlett BR, Kemberling H, Eyring AD, Skora AD, Luber BS, Azad NS, Laheru D, Biedrzycki B, Donehower RC, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Duffy SM, Goldberg RM, de la Chapelle A, Koshiji M, Bhaijee F, Huebner T, Hruban RH, Wood LD, Cuka N, Pardoll DM, Papadopoulos N, Kinzler KW, Zhou S, Cornish TC, Taube JM, Anders RA, Eshleman JR, Vogelstein B, Diaz LA Jr. PD-1 Blockade in Tumors with Mismatch-Repair Deficiency. N Engl J Med. 2015 Jun 25;372(26):2509-20. doi: 10.1056/NEJMoa1500596. Epub 2015 May 30.

    PubMed 26028255

  • Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazieres J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Perol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Janne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022 Jan 20;386(3):241-251. doi: 10.1056/NEJMoa2112431. Epub 2021 Sep 18.

    PubMed 34534430

  • Marabelle A, Fakih M, Lopez J, Shah M, Shapira-Frommer R, Nakagawa K, Chung HC, Kindler HL, Lopez-Martin JA, Miller WH Jr, Italiano A, Kao S, Piha-Paul SA, Delord JP, McWilliams RR, Fabrizio DA, Aurora-Garg D, Xu L, Jin F, Norwood K, Bang YJ. Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study. Lancet Oncol. 2020 Oct;21(10):1353-1365. doi: 10.1016/S1470-2045(20)30445-9. Epub 2020 Sep 10.

    PubMed 32919526

  • Mok TSK, Wu YL, Kudaba I, Kowalski DM, Cho BC, Turna HZ, Castro G Jr, Srimuninnimit V, Laktionov KK, Bondarenko I, Kubota K, Lubiniecki GM, Zhang J, Kush D, Lopes G; KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. doi: 10.1016/S0140-6736(18)32409-7. Epub 2019 Apr 4.

    PubMed 30955977

  • Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.

    PubMed 32101663

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Urachal Cancer and Parathyroid Carcinoma, run by Instituto do Cancer do Estado de São Paulo at 5 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 71 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Objective (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06638931, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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