2024-514179-17-00招募中3 期
A Randomized Phase III Trial of Platinum Chemotherapy plus Paclitaxel with Bevacizumab and Atezolizumab versus Platinum Chemotherapy plus Paclitaxel and Bevacizumab in Metastatic (stage IVB), Persistent, or Recurrent Carcinoma of the Cervix (BEATcc )
Grupo Espanol De Investigacion En Cancer De Ovario59 个研究点 分布在 6 个国家目标入组 339 人开始时间: 2024年10月23日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 339
- 试验地点
- 59
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
- To determine the progression free survival (PFS) of combining atezolizumab to chemotherapy (cisplatin or carboplatin/paclitaxel [CP]) and bevacizumab compared to CP and bevacizumab.
- To determine whether the addition of atezolizumab to chemotherapy (CP) plus bevacizumab improves overall survival (OS) compared to CP plus bevacizumab.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients must be ≥18 years of age
- •Adequate organ function: o Hemoglobin ≥9 g/dL (transfusion and / or erythropoietin permitted) o ANC ≥1.5 × 109/L o Lymphocyte count ≥0.5 × 109/L o Platelet count ≥100 x 109/L
- •Adequate liver function: o Serum albumin ≥2.5 g/dL o Total serum bilirubin ≤1.5 ×ULN o AST and ALT ≤2.5 × ULN or ≤5 × ULN if tumor involvement (liver) is present
- •Adequate renal function: o Patients with serum creatinine <1.5 × ULN o Urine dipstick for proteinuria <2+. Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate <1 g of protein in 24 hours or urine protein/creatinine (UPC) ratio ≤ 1.0
- •Adequate coagulation: o Blood coagulation parameters (PTT, PT/INR): PT such that international normalized ratio (INR) is ≤1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT <1.5 × ULN.
- •Negative Test Results for Hepatitis
- •Toxicities related to previous treatments must be recovered to < grade 2 (with the exception of alopecia).
- •Female participants must be postmenopausal (≥ 12 months of nontherapyinduced amenorrhoea) or surgically sterile (absence of ovaries and/or uterus, or who received therapeutic radiation to the pelvis) or otherwise have a negative serum pregnancy test within 7 days of the first study treatment and agree to abstain from heterosexual intercourse or use single or combined contraceptive methods that result in a failure rate of <1% per year during the whole treatment period of the study and for at least 5 months (if the last study dose contained atezolizumab) or 6 months (if the last study dose contained bevacizumab) after the last dose of study treatment.
- •Signed informed consent before any study-specific procedure
- •Able (in the investigator´s judgment) to comply with the study protocol
- •GOG/Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Life expectancy ≥3 months
- •Histologically- or cytologically-confirmed diagnosis of metastatic (stage IVB), persistent, or recurrent cervical cancer (histologies other than squamous cell, adenocarcinoma, or adenosquamous will be excluded) not amenable for curative treatment with surgery and/or radiation therapy. The inclusion of patients with adenocarcinoma histology will be capped to 20% of the whole study population
- •No prior systemic anti-cancer therapy for metastatic or recurrent disease. - Concurrent chemo-radiotherapy treatment with curative intent or adjuvant chemo-radiotherapy must have been completed ≥3 months (90 days) prior to enrollment. - Palliative radiation therapy (e.g., for pain or bleeding) 6 weeks prior enrollment is allowed as long as this does not affect measurable disease and patients are recovered from its symptoms.
- •Measureable disease by RECIST v1.1 criteria: Patients must have at least 1 "target lesion" to be used to assess response on this protocol as defined by RECIST v1.
- •If the only target lesion is limited to the radiation field, a biopsy is required to confirm malignancy.
- •A tumor specimen is mandatory at study entry. This may be an archival biopsy or, in its absence, a tumor biopsy obtained within 3 months of randomization from a non-irradiated lesion. Paired recent biopsies at baseline (lesion not previously irradiated; within 3 months of randomization) and at progression disease will not be mandatory, nevertheless they are encouraged as long as these are feasible
排除标准
- •Disease that is suitable for local therapy administered with curative intent
- •Known brain metastases or spinal cord compression
- •History or evidence, following a neurological examination unless properly treated with standard medical treatment.
- •Patients with serious non-healing wound, ulcer, or bone fracture.
- •Acute intestinal obstruction or sub-occlusion episode in the last 6 months.
- •Active GI bleeding or GI ulcer
- •History of Crohn's disease or inflammatory bowel disease
- •Prior bowel resection ≤6 weeks preceding first study dose
- •History of diverticulitis requiring medical intervention.
- •NCI CTCAE (version 5.0) grade ≥2 enteritis.
- •Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to D1C
- •Prior radiotherapy delivered using cobalt.
- •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to D1C
- •Patients with active bleeding or pathologic conditions that carry high risk of bleeding
- •Current or recent chronic daily treatment with aspirin, clopidogrel, or current or recent use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes.
- •Patients with pre-existing Grade 2 or greater peripheral neuropathy.
- •History of any grade ≥3 venous thromboembolic event (VTE).
- •Patients with clinically significant cardiovascular disease.
- •Left ventricular ejection fraction defined by MUGA/ECHO below the institutional lower limit of normal
- •Uncontrolled tumor-related pain.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.
- •Patients with Stage IVA not amendable to concurrent chemo-radiation as primary treatment.
- •History of autoimmune disease.
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field is permitted.
- •Active tuberculosis
- •Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- •Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
- •Received therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1,Day
- •Known human immunodeficiency virus (HIV).
- •Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study.
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
- •Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day
- •Ongoing disease involving the bladder or rectum at screening/baseline
- •Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day
- •The use of corticosteroids is allowed as premedication for paclitaxelbased regimen
- •Currently participating or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study treatment.
- •Prior anti-cancer monoclonal antibody (mAb), prior chemotherapy, targeted small molecule therapy as first line treatment for the treatment of metastatic or recurrent cervical cancer.
- •Women that are breastfeeding or pregnant
- •Known hypersensitivity to bevacizumab, atezolizumab or any of theirs excipients (including Cremophor).
- •No medical or psychiatric illness that may impede the performance of a systemic or surgical treatment
- •Demonstration of any other neurological or metabolic dysfunction
- •Evidence of abdominal free air.
- •Bilateral hydronephrosis.
- •Patients previously treated with chemotherapy
- •Prior treatment with any anti-VEGF drug
- •Patients with a concomitant malignancy other than non-melanoma skin cancer
结局指标
主要结局
Progression free survival (PFS)
Progression free survival (PFS)
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Objective Response Rate (ORR)
- Duration of response (DOR)
- Frequency and severity of adverse events
- Time from randomization to first subsequent therapy or death (TFST)
- Time from randomization to second progression (PFS2) based on radiologic assessment, start of a new line of therapy, symptomatic deterioration or death
- Mean and mean changes from baseline score in patient function (role, physical) and GHS/HRQoL.
- Proportion of patients reporting each response option
- Utility scores of the EQ-5D-5L questionnaire.
- Relationship between tumour immune-related or disease type-related biomarkers.
- Relationship between certain exploratory biomarkers
- Relationship between ATB use within 2 months before and 1 month after the first study administration with atezolizumab efficacy as measured by PFS and OS.
研究者
APICES SOLUCIONES S.L, Clinical Operations Department
Scientific
Grupo Espanol De Investigacion En Cancer De Ovario
研究点 (59)
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