BridgeMD
New treatment option for Urachal Cancer
Official title Agnostic Therapy in Rare Solid Tumors
ClinicalTrials.gov ID: NCT06638931
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for urachal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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
- 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Fortaleza, Ceará, Brazil
- Salvador, Estado de Bahia, Brazil
- Curitiba, Paraná, Brazil
- Recife, Pernambuco, Brazil
- São Paulo, São Paulo, Brazil
- Brasília, Brazil
- Rio de Janeiro, Brazil
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fortaleza, Ceará, Brazil; Salvador, Estado de Bahia, Brazil; Curitiba, Paraná, Brazil; Recife, Pernambuco, Brazil; São Paulo, São Paulo, Brazil; Brasília, Brazil and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.