EUCTR2016-004403-31-IT招募中1 期
MITO END-3: A randomized phase II trial of Carboplatin+Paclitaxel compared to Carboplatin+Paclitaxel+Avelumab in advanced (stage III-IV) or recurrent endometrial cancer - MITO END-3
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1.Female aged ³ 18 years on day of signing informed consent
- •2.ECOG Performance Status of 0–1
- •3.Patients with newly diagnosed or recurrent EC FIGO stage III-IV and histologically-confirmed (any histology except sarcoma and carcinosarcoma)
- •4.Patients may have received adjuvant treatment (platinum-based cytotoxic chemotherapy and/or radiotherapy). Patients having received prior chemotherapy must have completed their treatment at least 6 months prior to registration for protocol therapy. Patients having received prior radiotherapy must have completed their treatment at least 28 days prior to registration for protocol therapy
- •5.Have measurable disease based on RECIST v1.1 criteria
- •6.Availability of tumor samples for biomarker analysis
- •7.Endometrial cancer will include all carcinomas, including endometrioid carcinoma, papillary serous carcinoma, clear cell carcinoma
- •8.Adequate hematological function defined by absolute neutrophil count (ANC) = 1.5 × 109/L, platelet count = 100 × 109/L, and hemoglobin = 9 g/dL (may have been transfused)
- •9.Adequate hepatic function defined by a total bilirubin level = 1.5 × the upper limit of normal (ULN) range and AST and ALT levels = 2.5 × ULN for all subjects (or = 5 x ULN if liver metastases are present)
- •10.Adequate renal function defined by an estimated creatinine clearance = 50 mL/min according to the Cockcroft-Gault formula or serum creatinine = 1.5 ULN (for local institutional standard method)
- •11.Alkaline phosphatase < 1.5 x ULN for the institution (if > 1.5 x ULN, then alkaline phosphatase liver fraction must be < 1.5 ULN)
- •12.Be willing and able to provide written informed consent/assent for the trial
- •13.Females of childbearing potential must have a negative serum pregnancy test (serum hCG) at screening. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for =1 year
- •14.Highly effective contraception for females if the risk of conception exists. (Note: The effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential must agree to use 2 highly effective contraception, defined as methods with a failure rate of less than 1 % per year). Highly effective contraception is required at least 28 days prior, throughout and for at least 60 days after Avelumab treatment
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Women who are pregnant or lactating
- •2.Patients with brain metastases,
- •3.Prior Anticancer treatment for advanced disease and/or prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. Previous hormonal therapy for advanced disease is allowed, but treatment must be discontinued at least 28 days prior to registration for protocol therapy
- •4.History of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
- •5.Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade = 3)
- •6.Prior organ transplantation, including allogeneic stem cell transplantation
- •7.Significant acute or chronic infections including,
- •8.Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- •9.Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy Grade = 2 is acceptable
- •10.Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ).
- •11.Concurrent treatment with immunosuppressive or investigational agents EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- •12.Active cardiac disease
- •13.Known alcohol or drug abuse
- •14.Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
- •15.Any psychiatric condition that would prohibit the understanding or rendering of informed consent
- •16.All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the Investigator, All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma) including recent or active suicidal ideation or behavior, which, in the opinion of the Investigator, may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
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