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: 2024年4月23日

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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