EUCTR2017-004387-35-IT进行中（未招募）1 期
A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with Advanced Endometrial Cancer - Phase 3 study of lenvatinib plus pembrolizumab for advanced endometrial cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 780
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. Histologically confirmed diagnosis of endometrial carcinoma.
- •2. Documented evidence of advanced, recurrent or metastatic EC.
- •3. Radiographic evidence of disease progression after 1 prior systemic, platinum-based
- •chemotherapy regimen for EC. Participants may have received up to 1 additional line of
- •platinum-based chemotherapy if given in the neoadjuvant or adjuvant treatment setting.
- •4. Available historical or fresh tumor biopsy specimen for determination of MMR status.
- •5. At least 1 measurable target lesion according to RECIST 1.1 and confirmed by BICR,
- •including the following criteria:
- •- Non-nodal lesion that measures >=1.0 cm in the longest diameter
- •- Lymph node (LN) lesion that measures as >=1.5 cm in the short axis
- •- The lesion is suitable for repeat measurement using computed tomography/magnetic
- •resonance imaging (CT/MRI). Lesions that have had external beam radiotherapy (EBRT) or
- •locoregional therapy must show radiographic evidence of subsequent growth.
- •6. ECOG performance status of 0 or 1 within 7 days of starting study treatment.
- •7. Female participants age >=18 years and considered an adult per local regulations at
- •the time of informed consent.
- •8. A female participant is eligible to participate if she is not pregnant, not
- •breastfeeding, and at least one of the following conditions applies:
- •a.) Not a WOCBP
- •b.) A WOCBP who agrees to follow the contraceptive guidance during the treatment period
- •and for at least 120 days (for participants treated with lenvatinib plus pembrolizumab)
- •or at least 180 days (for participants treated with TPC) after the last dose of study
- •9. The participant provides written informed consent for the study.
- •10. Adequately controlled blood pressure (BP) with or without antihypertensive
- •medications, defined as BP <=150/90 mm Hg at Screening and no change in antihypertensive
- •medications within 1 week before C1D1.
- •11. Have adequate organ function. Specimens must be collected within 7 days prior to the
- •start of study 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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •1. Carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma and
- •endometrial stromal sarcomas.
- •2. CNS metastases, unless participants have completed local therapy and have
- •discontinued the use of corticosteroids for at least 4 weeks before starting treatment.
- •Any signs or symptoms of CNS metastases must be stable for at least 4 weeks before
- •starting study treatment.
- •3. Active malignancy (except for endometrial cancer, definitively treated in-situ
- •carcinomas, or basal or squamous cell carcinoma of the skin) within the past 24 mo.
- •4. Gastrointestinal malabsorption or anastomosis, or any other condition that might
- •affect the absorption of lenvatinib.
- •5. Has a pre-existing Grade >=3 gastrointestinal or non-gastrointestinal fistula.
- •6. Radiographic evidence of major blood vessel invasion/infiltration for which the
- •degree should be considered because of the potential risk of severe hemorrhage
- •associated with tumor shrinkage/necrosis following lenvatinib therapy.
- •7. Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first
- •dose of study drug.
- •8. Significant cardiovascular impairment within 12 mo of the first dose of study drug:
- •such as history of congestive heart failure greater than NYHA Class II, unstable angina,
- •myocardial infarction or cerebrovascular accident stroke, or cardiac arrhythmia
- •associated with hemodynamic instability.
- •9. Active infection (any infection requiring systemic treatment).
- •10. Participants who have not recovered adequately from any toxicity and/or
- •complications from major surgery prior to starting therapy.
- •11. Participants known to be positive for Human Immunodeficiency Virus (HIV).
- •12. Known active Hepatitis B or Hepatitis C.
- •13. Has a history of (non-infectious) pneumonitis that required treatment with steroids,
- •or has current pneumonitis.
- •14. Has a history or current evidence of any condition, therapy, or laboratory
- •abnormality that might confound the results of the study, interfere with the
- •participant's participation for the full duration of the study, or is not in the best
- •interest of the participant to participate, in the opinion of the treating investigator.
- •15. Has known psychiatric or substance abuse disorders that would interfere with
- •cooperation with the requirements of the study.
- •16. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- •(in dosing > 10 mg daily of prednisone equivalent) or any other form of mmunosuppressive
- •therapy within 7 days prior to the first dose of study drug.
- •17. Active autoimmune disease (with the exception of psoriasis) that has required
- •systemic treatment in the past 2 years. Replacement therapy is not considered a form of
- •systemic treatment.
- •18. Has had an allogenic tissue/solid organ transplant.
- •19. Females who are breastfeeding or pregnant at Screening or Baseline NYHA Class II,
- •unstable angina, myocardial infarction or cerebrovascular accident stroke, or cardiac
- •arrhythmia associated with hemodynamic instability.
- •20. Greater than 1 prior systemic chemotherapy regimen (other than adjuvant or
- •neoadjuvant) for EC. Participants may receive up to 2 regimens of platinum-based
- •chemotherapy in total, as long as one is given in the neoadjuvant or adjuvant treatment
- •21. Prior anticancer treatment within 28 days (or 5 times the half-life time, whichever
- •is shorter). All acute toxicities related to prior treatments must be resolved to Grade
- •<=1, except for alopecia and Grade <=2 peripheral neuropath
研究者
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