면역원성이 낮은 종양에 대한 atezolizumab 및 tivozanib 병용 요법¶

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

안내

이 페이지는 자동 수집·AI 요약된 정보입니다. 의료 조언이 아니며, 치료 결정은 반드시 담당 의료진과 상의하세요. 응급 상황은 응급 가이드 또는 119.

항목	내용
등록번호	NCT05000294
상태	모집 중
단계	1상/2상
시험 약물/중재	Atezolizumab, Tivozanib
대상 질환	Bile Duct Cancer, Gall Bladder Cancer, Breast Cancer, Neuroendocrine Tumors, Ovarian Cancer, Pancreatic Adenocarcinoma
스폰서	University of Florida
연령·성별	18 Years ~ 99 Years · ALL
목표 인원	29
시작 / 1차 완료 예정	2021-12-07 / 2026-12
국내 실시기관	없음
실시 국가	1개국, 기관 1곳 (United States)
결과 게시	아니오
최근 갱신	2026-07-13

문의처 (등록된 중앙 연락처)¶

Chloe Quintero 352-294-8819 chloe.quintero@ufl.edu

국내 기관 참여 문의는 해당 병원 임상시험센터 또는 담당 주치의를 통해 하세요. 참여 방법 안내

시험 개요¶

이 임상시험은 면역항암제 치료에 반응이 낮은 면역학적으로 차가운 종양 환자를 대상으로 면역관문억제제 atezolizumab과 혈관내피성장인자 수용체 티로신 키나아제 억제제(VEGF-TKI) tivozanib을 병용하여 평가합니다. 췌장암을 포함한 다양한 진행성 또는 전이성 고형암 환자 29명을 목표로 모집합니다. 연구의 목적은 VEGF 억제를 통해 면역항암제의 효과를 증대시킬 수 있는지 확인하는 것입니다.

목표 환자 수는 총 29명입니다.
중재 치료로 atezolizumab과 tivozanib을 병용합니다.
진행성, 절제 불가능 또는 전이성 췌장암 선암(pancreatic adenocarcinoma) 환자가 포함됩니다.

참여 조건 (AI 정리, 원문 확인 필요)¶

선정 기준: - 18세 이상의 성인 환자. - 진행성, 절제 불가능 또는 전이성 질환에 대해 최소 1차 이상의 전신 치료를 받았거나 표준 치료에 부적합한 환자. - 췌장 선암(pancreatic adenocarcinoma) 등의 임상적으로 확진된 병기 IV의 면역학적으로 차가운 암. - ECOG 수행 능력 상태가 1단계(상 1B) 또는 2단계(상 2) 이하인 환자. - RECIST 기준에 따른 측정 가능한 병변 존재. - 예상 여명이 12주 이상인 환자. 제외 기준: - MSI-H 또는 dMMR 종양 상태가 알려진 환자. - 조절되지 않는 심한 고혈압 환자. - 이전에 VEGF 수용체 티로신 키나아제 억제제로 치료받은 적이 있는 환자. - 임신 중이거나 수유 중인 여성. - 자가면역 질환의 활성 또는 병력이 있는 환자.

선정/제외 기준 원문 (영어)

Inclusion Criteria:

Subjects must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has refused or for whom there are no standard therapies that impart significant clinical benefit in the opinion of the treating investigator.
An Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1 for phase 1B. An ECOG Performance Status less than or equal to 2 for phase 2.
Subjects must not have more than one malignancy at the time of enrollment
Adult subjects ≥ eighteen years of age
A clinical diagnosis consistent with stage IV "immunogenically cold" or otherwise incurable cancer of one of the following histologies: i) bile duct or gallbladder cancer ii) Metastatic breast cancer, HR-negative HER2-positive, who have received at least 3 lines of therapy for disease progression that includes: trastuzumab, pertuzumab/trastuzumab, and ado-trastuzumab emtansine iii) neuroendocrine cancer with the following pathological characteristics: grade 2 or 3; well- or moderately- differentiated (Grades 1, 4, and poorly differentiated neuroendocrine pathologies are not eligible) iv) FIGO stage IV or metastatic (using 2021 FIGO classification) high grade serious or high grade endometrioid (based on local histopathological findings) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer that is platinum resistant, with no acceptable standard of care v) pancreatic adenocarcinoma vi) soft tissue sarcoma vii) prostate cancer subjects who are castrate-resistant (testosterone ≤ 50 ng/dL) and have progressed on, declined, or are intolerant to other standard of care therapies. Subjects with prostate cancer must have failed at least one line of treatment with an androgen inhibitor (AI) (i.e. enzalutamide, abiraterone, etc.) or cytotoxic chemotherapy in the advanced or metastatic setting viii) vulvar cancer
Adequate hematologic and end-organ function
Subjects receiving therapeutic anticoagulation must be on a stable anticoagulant regimen for ≥ 2 weeks at start of protocol treatment
Negative hepatitis B surface antigen (HBsAg) test at screening
Negative HIV test at screening with the following exceptions: subjects with a positive HIV test at screening are eligible only if they meet the following three conditions: 1) Are stable on anti-retroviral therapy 2) Have a CD4 count ≥ 200/uL AND 3) Have an undetectable viral load.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception (with a failure rate of \<1% per year) to avoid pregnancy throughout the study and for at least 160 days after the last dose of either study drug to minimize the risk of pregnancy.
Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving children for 160 days following the last dose of study drug.
Measurable disease by RECIST criteria
A life expectancy of ≥ 12 weeks
Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures
Must have formalin-fixed paraffin embedded (FFPE) tissue or 12 unstained slides available for research purposes. Tissue must have been obtained within the last 3 years.
If a new biopsy is needed for diagnostic reasons, the biopsy must be performed from a tumor site that is not the only site of measurable disease
Subject must be able to swallow capsules

Exclusion Criteria:

Subjects with known MSI-H or dMMR tumor status
Subjects with severe uncontrolled hypertension as defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg
Subjects who have had prior treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 160 days after the last dose of study drug
Females who are pregnant or breastfeeding
History of leptomeningeal disease
Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN)
Uncontrolled tumor-related pain
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently, except in the case of ovarian cancer with ascites, which may require more frequent drainage). Subjects with indwelling catheters are allowed.
Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
- Rash must cover \<10% of body surface area
- Disease is well controlled at baseline and requires only lowpotency topical corticosteroids
- There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Active tuberculosis
Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
History of malignancy other than the malignancies listed in the inclusion criteria of enrollment within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Severe infection within 4 weeks prior to initiation of study treatment including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Note: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
Prior allogeneic stem cell or solid organ transplantation
Current treatment with anti-viral therapy for hepatitis B virus (HBV)
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician
Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment, during treatment with atezolizumab, and for 160 days after the last dose of atezolizumab. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Subjects may receive non-live COVID-19 vaccine.
Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Subjects with Tumor Mutation Burden (TMB) ≥10
Treatment with any cancer directed therapy (i.e. chemotherapy, radiation therapy, Y90, microwave ablation, immunotherapy, etc.) within 28 days of study start
Subjects with treated brain metastases that have remained stable for at least 90 days without steroids are allowed. Subjects with signs of symptoms or history of brain metastasis must have a CT or MRI of the brain within 30 days prior to the start of protocol therapy.
Subjects with autoimmune diseases requiring current treatment and subjects with history of severe autoimmune diseases, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency who are stable on therapy are allowed.
Inability to discontinue use of medications contraindicated by the study treatment
Proteinuria > 2.5 g/24 hours or 3+ with urine dipstick
QTc interval > 470 at screening or known cardiovascular disease defined as (a) a clinically significant abnormal ECG at screening, or (b) myocardial infarction within 12 weeks prior to start of protocol therapy

출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06

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