PER-015-23招募中2 期
A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE-158)
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)0 个研究点目标入组 2 人开始时间: 2023年12月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2
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
- All
入选标准
- •Be willing and able to provide documented informed consent/assent for the trial. The subject (or their legally acceptable representative) may also provide consent/assent for
- •Future Biomedical Research. However, the subject may participate in the main trialwithout participating in Future Biomedical Research.
- •Be =18 years of age on the day of providing documented informed consent.
- •Have a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard first-line treatment has failed. Patients must have progressed on or be intolerant to therapies that
- •are known to provide clinical benefit. There is no limit to the number of prior treatment regimens.
- •Have one of the following advanced (unresectable and/or metastatic) tumor types:
- •(A) Anal Squamous Cell Carcinoma,
- •(B) Biliary Adenocarcinoma (gallbladder or biliary tree) (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater Cancers,
- •(C) Neuroendocrine Tumors (well- and moderately-differentiated), of the lung, appendix, small intestine, colon, rectum, or pancreas,
- •(D) Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded),
- •(E) Cervical Squamous Cell Carcinoma,
- •(F) Vulvar Squamous Cell Carcinoma,
- •(G) Small Cell Lung Carcinoma,
- •(H) Mesothelioma (Malignant Pleural Mesothelioma),
- •(I) Thyroid Carcinoma (Papillary or Follicular Subtypes),
- •(J) Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded)
- •(K)Any advanced solid tumor (except CRC), which is MSI-H.
- •(L)Any advanced solid tumor (including CRC*) which is dMMR/MSI-H in patients from mainland China who are of Chinese descent.
- •Non-CRC and CRC subjects in Group L are to meet all inclusion criteria as outlined in Section 5.1.2.
- •In addition, CRC subjects in Group L are to meet the specific lines of therapy criteria listed below: Have a histologically proven locally advanced unresectable or metastatic CRC which is dMMR/MSI-H that has received 2 prior lines of therapy.
- •(M)Any advanced solid tumor that has failed at least one line of therapy and is TMB-H (=10 mut/Mb, F1CDx assay), excluding dMMR/MSI-H tumors.
- •Have submitted an evaluable tissue sample for biomarker analysis from a tumor lesion not previously irradiated (exceptions may be considered after consultation with and approval by the Sponsor) (See Laboratory Manual for detailed instructions). The tumor tissue submitted for analysis must be from a single tumor tissue specimen and of sufficient quantity and quality to allow assessment of ALL required primary biomarkers.
- •If enrollment in Groups A-J has moved to biomarker enrichment, have a tumor that is positive for one or more of the prespecified primary biomarker(s), as assessed
排除标准
- •Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of treatment.
- •Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). No HIV testing is required unless mandated by local health authority.
- •Has known active Hepatitis B (ie, HBsAg positive) or Hepatitis C (eg, HCV RNA [qualitative] is detected). No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- •Has received a live vaccine within 30 days of planned start of study therapy. Refer to Section 5.5.2 for information on COVID-19 vaccines.
- •Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
- •Has a known history of active tuberculosis (TB, Bacillus tuberculosis).
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
- •Has an active autoimmune disease that has required systemic treatment in the 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) or treatment with drugs (eg, neomercazole, carbimazole, etc.) that function to decrease the generation of thyroid hormone by a hyperfunctioning thyroid gland (eg, in Graves’ disease) is not considered a form of systemic treatment of an autoimmune disease.
- •Has had a prior anticancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (ie, =Grade 1 or at baseline) from an AE due to mAbs administered more than 4 weeks earlier.
- •Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (ie, =Grade 1 or at baseline) from an AE due to a previously administered agent.
- •Has a known additional malignancy within 2 y
研究者
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