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临床试验/NL-OMON54608
NL-OMON54608已完成3 期

A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177) - MK3475-177

Merck Sharp & Dohme (MSD)0 个研究点目标入组 15 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
15
研究概览入排标准研究者记录与标识符相似试验

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

年龄范围
18 至 99（—）

入选标准

  • •1. Provide documented informed consent for the study.
  • •2. Be male or female who is >= 18 years of age on the date of signing informed
  • •3. Have locally confirmed MMR deficient (dMMR) or microsatellite instability
  • •high (MSI-H) stage IV colorectal carcinoma
  • •4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
  • •1 within 10 days prior to treatment initiation.
  • •5. Have life expectancy of at least 3 months
  • •6. Have measurable disease at baseline based on RECIST 1.1 as determined by the
  • •local site Investigator/radiology assessment.
  • •7. Female subjects of childbearing potential must have a negative serum
  • •pregnancy test within 72 hours prior to receiving the first dose of study
  • •medication.
  • •8. Female subjects of childbearing potential must be willing to use an adequate
  • •method of contraception for the course of the study starting with the first
  • •dose of study medication through 180 days after the last dose of study
  • •medication for the chemotherapy arm and 120 days for pembrolizumab arm,
  • •whichever is later.
  • •9. Male subjects of childbearing potential must agree to use an adequate method
  • •of contraception as outlined in Section 5.7.2 - Contraception, starting with
  • •the first dose of study medication through 180 days after the last dose of
  • •study medication for the chemotherapy arm (no contraception requirement for
  • •pembrolizumab MK-3475 arm).
  • •10. Demonstrate adequate organ function. All screening laboratory assessment
  • •should be performed within 10 days prior to treatment initiation.

排除标准

  • •1. Has received prior systemic therapy for stage IV CRC. Subjects may have
  • •received prior adjuvant chemotherapy for CRC as long as it was completed at
  • •least 6 months prior to randomization.
  • •2. Is currently participating and receiving study medication in another study,
  • •or has participated in a study of an investigational agent and received study
  • •medication, or used an investigational device within 4 weeks of randomization.
  • •3. Has an active autoimmune disease that has required systemic treatment in
  • •past 2 years (i.e. 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, etc.) is not considered a form of systemic treatment.
  • •4. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy
  • •or any other form of immunosuppressive therapy within 7 days prior to
  • •randomization.
  • •5. Has had radiation therapy within 4 weeks prior to randomization of study
  • •medication and who has not recovered to baseline from adverse events due to
  • •radiation therapy. Subjects who have been given palliative radiotherapy to
  • •peripheral sites (e.g., bone metastasis) may enter the study before 4 weeks
  • •have elapsed but must have recovered from any acute adverse effects.
  • •6. Has known active central nervous system (CNS) metastases and/or
  • •carcinomatous meningitis. Subjects with previously treated brain metastases may
  • •participate provided they have stable brain metastases [without evidence of
  • •progression by imaging as confirmed by magnetic resonance imaging (MRI) if MRI
  • •was used at prior imaging, or confirmed by computed tomography (CT) imaging if
  • •CT used at prior imaging] at least four weeks prior to the first dose of study
  • •medication; also, any neurologic symptoms must have returned to baseline], and
  • •have not used steroids for brain metastases for at least 28 days prior to trial
  • •initiation. This exception does not include carcinomatous meningitis, as
  • •subjects with carcinomatous meningitis are excluded regardless of clinical
  • •7. Has had major surgical procedure, open biopsy or significant traumatic
  • •injury within 28 days prior to randomization.
  • •8. Has received prior therapy with an immune checkpoint inhibitor (e.g.,
  • •anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or anti-CTLA-4 agent, etc).
  • •9. Has another malignancy that is progressing or requires active treatment.
  • •Exceptions include non-melanomatous skin cancer that has undergone potentially
  • •curative therapy and in situ cervical carcinoma.
  • •10. Has received a live vaccine within 30 days of planned start of study
  • •medication.
  • •11. Has a history or current evidence of any condition, therapy, or laboratory
  • •abnormality that might confound the results of the study, interfere with the
  • •subject*s participation for the full duration of the study, or is not in the
  • •best interest of the subject to participate, in the opinion of the treating
  • •Investigator.
  • •12. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2
  • •antibodies), active chronic or acute Hepatitis B (e.g., HBsAg reactive) or
  • •Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • •13. Has known history of, or any evidence of interstitial lung disease or
  • •active, non-infectious pneumonitis.
  • •14. Has a known

研究者

发起方
Merck Sharp & Dohme (MSD)

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