EUCTR2016-004351-75-IT进行中（未招募）1 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564) - Ph 3 Placebo-Controlled Trial of Adjuvant MK-3475 in RCC Post Nephrectomy
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 950 人开始时间: 2021年2月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 950
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
- All
入选标准
- •1. Must have histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features. Diagnosis of RCC with clear cell component is to be made by the investigator and does not require central histology review
- •2. Be = 18 years of age on day of signing informed consent
- •3. Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •4. Female participants of childbearing potential must be willing to use an adequate method of contraception as outlined in the protocol, for the course of the trial through 120 days after the last dose of trial drug
- •5. Male participants of childbearing potential must be willing to use an adequate method of contraception as outlined in the protocol, for the course of the trial through 120 days after the last dose of trial drug
- •6. The participant provides written informed consent/assent for the trial. The participant may also provide consent/assent for Future Biomedical Research; however the participant may participate in the main trial without participating in Future Biomedical Research
- •7. Have intermediate-high risk, high risk, or M1 NED RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status:
- •a) Intermediate-high risk RCC
- •- pT2, Gr. 4 or sarcomatoid, N0, M0
- •- pT3, Any Gr., N0, M0
- •b) High risk RCC
- •- pT4, Any Gr. N0, M0
- •- pT Any stage, Any Gr., N+, M0
- •c) M1 NED RCC -participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following:
- •- the time of nephrectomy (synchronous) or,
- •- =1 year from nephrectomy (metachronous)
- •8. Have received no prior systemic therapy for advanced RCC
- •9. Have undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants) with negative surgical margins
- •10. Must have undergone a nephrectomy and/or metastasectomy =28 days prior to signing informed consent and =12 weeks prior to randomization.
- •11. Must be tumor-free as assessed by the Investigator and validated by either CT or MRI scan of the brain and CAP and a bone scan =28 days from randomization. All baseline scans must be sent to the central imaging vendor and receipt must be confirmed prior to randomization
- •12. Must have provided adequate tissue per the following:
- •- Nephrectomy only: tissue from nephrectomy (required).
- •- Synchronous M1 NED: tissue from nephrectomy (required) AND, metastasectomy issue (if available).
- •- Metachronous M1 NED: tissue from metastasectomy (required) AND, nephrectomy tissue (if available).
- •Adequacy of the samples for biomarker analysis will be evaluated by a central laboratory.
- •13. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- •14. Have adequate organ function as defined in the protocol. Specimens must be collected within 10 days prior to randomization
- •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 475
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 475
排除标准
- •1. Has had major surgery, other than nephrectomy and/or resection of pre-existing metastases for M1 NED participants, within 12 weeks prior to randomization
- •2. Has received prior radiotherapy for RCC
- •3. Has pre-existing brain or bone metastatic lesions.
- •4. Has residual thrombus post nephrectomy in the vena renalis or vena cava
- •5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
- •6. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
- •7. Has a known additional malignancy that is progressing or required active treatment =3 years ago. Exceptions include early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer, or in situ breast cancer that has undergone potentially curative therapy
- •8. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- •9. Has an active infection requiring systemic therapy
- •10. Has a history of, or is currently on, dialysis
- •11. Has a known history of human immunodeficiency virus infection. No human immunodeficiency virus testing is required unless mandated by local health authority
- •12. Has a known active hepatitis B (hepatitis B surface antigen reactive) or hepatitis C virus (eg, hepatitis C virus [HCV] RNA [qualitative] is detected)
- •13. Has a known history of active tuberculosis (Bacillus tuberculosis)
- •14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •15. Has a known psychiatric or substance abuse disorder that would interfere with the cooperation with the requirements of the trial in the opinion of the investigator
- •16. Has had a prior solid organ transplant
- •17. Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients
- •18. A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours before randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Participants must be excluded/discontinued from the trial in the event of a positive or borderline positive test result
- •19. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the Screening visit through 120 days after the last dose of study treatment
- •20. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent or with an agent directed to another co-inhibitory T-cell receptor (ie, CTLA-4, OX-40, CD137) or has previously participated in a Merck pembrolizumab (MK 3475) clinical trial
- •For criteria #21, #22 and #23 refer to protocol
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