NL-OMON45068已完成2 期
Randomized, Phase II Study of Pembrolizumab (MK-3475) versus Chemotherapy in Patients with Advanced Melanoma (KEYNOTE 002). - MK3475-002
Merck Sharp & Dohme (MSD)0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
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) Patient must have a histologically or cytologically confirmed diagnosis of unresectable stage III or metastatic MEL not amenable to local therapy.
- •2) Patients must be refractory to IPI.
- •3) Resolution/improvement of IPI-related AEs (including irAEs) back to Grade 0-1 and *10 mg/day prednisone (or equivalent dose) for irAEs for at least 2 weeks prior to the first dose of study drug.
- •4) Patients must consent to provide a newly obtained tumor tissue/biopsy (or specimen obtained within 60 days prior to consenting) for biomarker analysis from a core or excisional biopsy of a tumor lesion not previously irradiated.
- •5) BRAF V600E or V600K mutation status must be known at Screening. Patients with BRAF mutant melanoma must have had a prior treatment regimen that included vemurafenib, dabrafenib, or an approved BRAF and/or MEK inhibitor.
- •6) Patient must have at least 1 radiologically measurable lesion as per RECIST 1.1 (Appendix 6.1) defined as a lesion that is 10 mm in longest diameter or lymph node that is 15 mm in short axis imaged by CT scan or MRI.
- •7) Patient is *18 years of age on day of signing informed consent.
- •8) Patient must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Appendix 6.4).
- •9) Patient must have adequate organ function.
- •10) Patient has voluntarily agreed to participate by giving written informed consent/assent for the trial. The patient may also provide consent/assent for future biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •11) Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours 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. The serum pregnancy test must be negative for the patient to be eligible.
- •12) Female patients enrolled in the study, who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy, or to abstain from heterosexual activity throughout the study, starting with Visit 1 through 120 days after the last dose of study drug. Approved contraceptive methods include 2 of the following methods (or 1 of the following methods combined with hormonal contraceptive), for example: intra-uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide. Spermicides alone are not an acceptable method of contraception.
- •13) Male patients must agree to use an adequate method of contraception starting with Visit 1 through 120 days after the last dose of study drug.
排除标准
- •1)Patient who has had chemotherapy, radioactive, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or who has not recovered to CTCAE Grade 1 or better from the AEs due to cancer therapeutics administered more than 4 weeks earlier.
- •2) Patient who received IPI only as an adjuvant therapy.
- •3) Patient is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study drug.
- •4) Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.
- •5) Patient is on chronic systemic steroid therapy (>10 mg/day prednisone or equivalent) within 2 weeks before the planned date for first dose randomized treatment or on any other form of immunosuppressive medication. (Patients that are expected to require premedication with corticosteroid for pembrolizumab will not be eligible for this study.)
- •6) Patient has a known history of a hematologic malignancy, primary central nervous system (CNS) malignancy or sarcoma, or of another primary solid tumor, unless the patient has undergone potentially curative therapy with no evidence of that disease for 5 years.
- •7) Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •8) Patient previously had a severe hypersensitivity reaction to treatment with another mAb.
- •9) Patient has an active autoimmune disease or a history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be exceptions to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Patients with hypothyroidism stable on hormone replacement will not be excluded from the study.
- •10) Patients who received treatment with live vaccines within 30 days prior to the first dose of study medication. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, seasonal flu, H1N1 flu, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine.
- •11) Patient had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent.
- •12) Patient has previously participated in Merck pembrolizumab clinical trials.
- •13) Patient has an active infection requiring systemic therapy.
- •14) Patient has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- •15) Patient is positive for active Hepatitis B (HBsAg reactive) or Hepatitis C (HCV ribonucleic acid [RNA] [qualitative] is detected). Patients with negative Hepatitis C antibody testing may not require RNA testing if deemed appropriate by treating physician.
- •16) Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- •17) Patient has known psychiatric or substance abuse disorders that would interfere with cooperation requirements of the trial.
- •18) Patient is, at the time of signing informed consent, a regular user (including recreational use) of any illicit drugs or had a recent history (within the last year) of substance abus
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