EUCTR2021-002193-63-LT进行中（未招募）1 期
A Phase 3 Trial of Balstilimab versus Investigator Choice Chemotherapy in Patients with Recurrent Cervical Cancer after Platinum-Based Chemotherapy - BRAVA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Agenus, Inc.
- 入组人数
- 486
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. = 18 years of age
- •2. Diagnosis and prior systemic treatment:
- •a. Has recurrent or metastatic cervical cancer (SCC, AC, or ASC histology), and has experienced disease progression during or after treatment with a standard platinum-based therapy with or without bevacizumab
- •b. Has received at least 1 prior systemic therapy regimens for recurrent, persistent, and/or metastatic cervical cancer
- •3. Measurable disease – based on Investigator assessment
- •a. Radiological evidence of measurable disease on imaging based on RECIST v1.1
- •Note: Patients must have at least 1 target lesion” to be used to assess response, as defined by RECIST v1.1. Tumors within a previously irradiated field will be designated as non-target” lesions unless progression is documented, or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
- •4. Has a life expectancy of at least 3 months and an ECOG performance status of 0 or 1
- •5. Patients must have sufficient and adequate formalin-fixed tumor tissue sample available that is not older than 3 years; otherwise, a fresh biopsy is required. Archival tissue or fresh biopsy must be from a site not previously irradiated
- •6. Has adequate organ function as indicated by the following laboratory values:
- •a. Adequate hematological function defined by absolute neutrophil count = 1.5 × 109/L, platelet count = 100 × 109/L, and stable hemoglobin = 8 g/dL (without transfusions within 1 week before first dose)
- •b. Adequate hepatic function based by a total bilirubin level = 1.5 × the upper limit of normal (ULN), aspartate aminotransferase (AST) level = 2.5 × ULN, alanine aminotransferase (ALT) level = 2.5 × ULN, alkaline phosphatase (ALP) = 2.5 ×ULN, and albumin = 3.0 mg/dL. In the case of hepatic metastases, < 5 × ULN for AST/ALT and ALP
- •c. Adequate renal function defined as calculated creatinine clearance > 40 mL/min or a serum creatinine less than 1.5 × ULN, per institutional standards (creatinine clearance should be calculated per institutional standards)
- •d. Adequate coagulation defined by international normalized ratio or prothrombin time = 1.5 × institutional upper limit of normal (IULN) (unless the patient is receiving anticoagulant therapy); and activated partial thromboplastin time = 1.5 × IULN (unless the patient is receiving anticoagulant therapy) e. Normal thyroid function (thyroid stimulating hormone) whether or not the patient is on supplemental thyroid hormone
- •7. Has no history of another primary malignancy except for:
- •a. Malignancy treated with curative intent and with no known active disease = 5 years before the first dose of study drug and of low potential risk for recurrence
- •b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •c. Adequately treated carcinoma in situ without evidence of disease
- •d. Adequate coagulation defined by international normalized ratio or prothrombin time = 1.5 × institutional upper limit of normal IULN unless the patient is receiving anticoagulant therapy) and activated partial thromboplastin time = 1.5 × IULN (unless the patient is receiving anticoagulant therapy).
- •e. Normal thyroid function (thyroid stimulating hormone) whether or not the patient is on supplemental thyroid hormone.
- •Other protocol defined inclusion criteria apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 255
排除标准
- •1. Has an inadequate period of time prior to first dose of study treatment that is defined as:
- •a. Received systemic cytotoxic chemotherapy or biological therapy within 3 weeks before initiation of study treatment
- •b. Received radiation therapy within 3 weeks before initiation of study treatment, except for palliative bone therapy, which can be received 2 weeks prior to initiation of study treatment
- •c. Had major surgery within 4 weeks before initiation of study treatment
- •2. Has received prior therapy with:
- •a. Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti–PD-1 and anti–PD-L1 antibodies
- •3. Has persisting toxicity related to prior therapy of NCI-CTCAE v5.0 Grade = 1 severity with the exceptions noted below:
- •a. Peripheral neuropathy Grade = 2
- •b. Alopecia Grade = 2
- •4. Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection)
- •5. Has known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI-CTCAE v5.0 Grade = 3), any history of anaphylaxis, or uncontrolled asthma
- •6. Is receiving systemic corticosteroid = 7 days prior to the first dose of trial treatment or receiving any other form of systemic immunosuppressive medication (corticosteroid use on trial for management of immune-related adverse events and/or a premedication for IV contrast allergies/reactions is allowed). Patients who are receiving daily corticosteroid replacement therapy are an exception to this rule. Examples of permitted therapy are daily prednisone at doses of 5 to 7.5 mg or equivalent hydrocortisone dose, and steroid therapy administered by topical, intraocular, intranasal, and/or inhalation routes
- •7. History of central nervous system tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the Screening Period or identified prior to consent
- •Note: Patients with a history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (based on 2 sets of brain images, performed = 4 weeks apart, and obtained after the brain metastases treatment). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be minimal and be expected as sequelae from treated lesions. For individuals who received steroids as part of brain metastases treatment, steroids must be discontinued = 7 days prior to the first dose of study drug
- •8. Has active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
- •Note: Patients with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible.
- •9. Has had an allogeneic tissue/solid organ transplant requiring ongoing immunosuppressive treatment
- •10. Has or had known drug-induced interstitial lung disease, not fully resolved, or has had a history of pneumonitis that has required oral or IV corticosteroids
- •11. Has an active infection requiring IV systemic treatment
- •12. Has known history of HIV (HIV 1/2 antibodies)
- •13. Has known untreated hepatitis B/hepatitis C virus (HBV/HCV) or tuberculosis. Active HBV is defined as a known positive hepatitis B surface antigen result.
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