NL-OMON55397已完成3 期
A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma; - Pembrolizumab in Advanced Gastric or GEJ Adenocarcinoma
Merck Sharp & Dohme (MSD)0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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 64（—）
入选标准
- •1. Be willing and able to provide documented informed consent/assent for the
- •trial. The subject may also provide consent/assent for Future Biomedical
- •Research. However, the subject may participate in the main trial without
- •participating in Future Biomedical Research., 2. Be * 18 years of age on day of
- •providing documented informed consent (or acceptable age according to local
- •regulations, whichever is older)., 3. Have a performance status of 0 or 1 on
- •the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 10 days
- •prior to the first dose of trial treatment., 4. Have histologically or
- •cytologically confirmed diagnosis of locally advanced unresectable or
- •metastatic gastric or GEJ adenocarcinoma. , 5. Be HER2/neu negative and PD-L1
- •positive., 6. Have measurable disease as defined by RECIST 1.1 as determined by
- •investigator assessment. Tumor lesions situated in a previously irradiated area
- •are considered measurable if progression has been demonstrated in such lesions.
- •, 7. Have provided tumor tissue sample deemed adequate for PD-L1 biomarker
- •analysis. , a. Notification of eligibility must be received prior to
- •randomization., b. Additional samples may be required if adequate tissue is not
- •provided., 8. Female subjects of childbearing potential must have a highly
- •sensitive negative urine or serum pregnancy test as required by local
- •regulation within 24 hours (urine) and within 72 hours (serum) prior to
- •receiving the first dose of study medication. If the urine test is positive or
- •cannot be confirmed as negative, a serum pregnancy test will be required. , 9.
- •Female subjects of childbearing potential must be willing to use an adequate
- •method of contraception, for the course of the study through 120 days after the
- •last dose of study medication. Note: Abstinence is acceptable if this is the
- •usual lifestyle and preferred contraception for the subject. , 10. Male
- •subjects of childbearing potential must agree to use an adequate method of
- •contraception starting with the first dose of study therapy through 120 days
- •after the last dose of study therapy. Note: Abstinence is acceptable if this is
- •the usual lifestyle and preferred contraception for the subject. , 11.
- •Demonstrate adequate organ function. All screening labs should be performed
- •within 10 days of treatment initiation.
排除标准
- •1. Has squamous cell or undifferentiated gastric cancer., 2. Has had previous
- •therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer.
- •Subjects may have received prior neoadjuvant or adjuvant therapy as long as it
- •was completed at least 6 months prior to randomization., 3. Has had major
- •surgery, open biopsy or significant traumatic injury within 28 days prior to
- •randomization, or anticipation of the need for major surgery during the course
- •of study treatment., 4. Has had radiotherapy within 14 days of randomization.
- •Subjects who received radiotherapy >14 days prior to randomization must have
- •completely recovered from any radiotherapy related AEs/toxicities., 5. Has a
- •known additional malignancy that is progressing or requires active treatment.
- •Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of
- •the skin that has undergone potentially curative therapy or in situ cervical
- •cancer., 6. Has known active central nervous system (CNS) metastases and/or
- •carcinomatous meningitis. Subjects with previously treated brain metastases
- •may participate provided they are stable (without evidence of progression by
- •imaging at least four weeks prior to the first dose of trial treatment and
- •neurologic symptoms have returned to baseline), have no evidence of new or
- •enlarging brain metastases, and are not using steroids for at least 7 days
- •prior to trial treatment. This exception does not include carcinomatous
- •meningitis which is excluded regardless of clinical stability., 7. 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 (e.g., thyroxine, insulin, or
- •physiologic corticosteroid replacement therapy for adrenal or pituitary
- •insufficiency, etc.) is not considered a form of systemic treatment. , 8. Has
- •a diagnosis of immunodeficiency or is receiving chronic systemic steroid
- •therapy (in dosin exceeding 10 mg daily of prednisone equivalent) or any other
- •form of immunosuppressive therapy within 7 days prior to the first dose of
- •trial drug. , 9. Has a history of (non-infectious) pneumonitis/interstitial
- •lung disease that required steroids or current pneumonitis/interstitial lung
- •disease. , 10. Has an active infection requiring systemic therapy., 11. Has a
- •history or current evidence of any condition (e.g. known deficiency of the
- •enzyme dihydropyrimidine dehydrogenase [DPD]), therapy, or laboratory
- •abnormality that might confound the results of the trial, interfere with the
- •subject*s participation for the full duration of the trial, or is not in the
- •best interest of the subject to participate, in the opinion of the treating
- •investigator., 12. Has known psychiatric or substance abuse disorders that
- •would interfere with cooperation with the requirements of the trial., 13. 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 trial treatment., 14. Has received prior
- •therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent., 15. Has a known
- •history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)., 16. Has
- •current active Hepatitis B (e.g., HBsAg reactive, posi
研究者
相似试验
进行中（未招募）
1 期
Ph III Trial of Pembrolizumab (MK-3475), pembrolizumab+FP/XP vs. Placebo+FP/XP in Biomarker Select, Advanced Gastric or GEJ AdenocarcinomaEUCTR2015-000972-88-BEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,750
进行中（未招募）
1 期
Ph III Trial of Pembrolizumab (MK-3475), pembrolizumab+FP/XP vs.Placebo+FP/XP in Biomarker Select, Advanced Gastric or GEJ AdenocarcinomaGastric or Gastroesophageal Junction AdenocarcinomaMedDRA version: 21.0Level: PTClassification code 10030137Term: Oesophageal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-000972-88-ITMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.750
进行中（未招募）
1 期
Ph III Trial of Pembrolizumab (MK-3475), pembrolizumab+FP/XP vs. Placebo+FP/XP in Biomarker Select, Advanced Gastric or GEJ AdenocarcinomaGastric or Gastroesophageal Junction AdenocarcinomaMedDRA version: 21.0Level: PTClassification code 10030137Term: Oesophageal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-000972-88-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,750
进行中（未招募）
1 期
Ph III Trial of Pembrolizumab (MK-3475), pembrolizumab+FP/XP vs. Placebo+FP/XP in Biomarker Select, Advanced Gastric or GEJ AdenocarcinomaEUCTR2015-000972-88-HUMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.750
进行中（未招募）
1 期
Ph III Trial of Pembrolizumab (MK-3475), pembrolizumab+FP/XP vs. Placebo+FP/XP in Biomarker Select, Advanced Gastric or GEJ AdenocarcinomaGastric or Gastroesophageal Junction AdenocarcinomaMedDRA version: 21.0Level: PTClassification code 10030137Term: Oesophageal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-000972-88-NLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,750