EUCTR2014-002950-38-Outside-EU/EEA进行中（未招募）不适用
A Phase I/II Study of Pembrolizumab (MK-3475) in Children with advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma (KEYNOTE-051) - A Phase I/II trial of MK-3475 (pembrolizumab) in children’s solid tumors and lymphoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 311
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Be willing and able to provide written 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 between 6 months and less than 18 years of age on day of signing informed consent/assent.
- •3. Have histologically or cytologically-documented, locally-advanced, or metastatic solid malignancy that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the patient and treating physician. There is no limit to the number of prior treatment regimens.
- •4. Be able to provide tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated (tumors progressing in a prior site of radiation are allowed for characterization, other exceptions may be considered after Sponsor consultation).
- •5. Have either advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma as determined by IHC in archival formal fixed paraffin embedded tumor (FFPET) or newly obtained biopsy. (Subjects with PD-L1 negative tumors may be enolled in Part II of the trial in selet tumor types where preliminary response is observed)
- •6. Have measurable disease based on RECIST 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. During Part I of the trial, subjects with neuroblastoma may be enrolled with evaluable disease.
- •7. Have a performance status as defined below:
- •Lansky Play Scale =70 for children up to and including 16 years of age;
- •Karnofsky score =70 for children > 16 years of age
- •8. Demonstrate adequate organ function
- •9.Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
- •10. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication.
- •11. Male subjects should 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 311
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Is currently participating and receiving study therapy in,or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •2. 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.
- •3. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to mAbs administered more than 4 weeks earlier.
- •4. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to a previously administered agent.
- •5. Has a known additional malignancy that is progressing or requires active treatment with limited exceptions.
- •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 [using the same imaging techniques for diagnosis and follow-up] for at least four weeks prior to the first dose of trial treatment and any 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. Patients with primary CNS tumors or metastases of primary CNS tumors are not excluded but must be neurologically stable (e.g. without a progression of neurologic symptoms or requiring systemic steroid therapy within last 2 weeks).
- •7. Has an active autoimmune disease that has required systemic treatment in past 2 years
- •8. Has evidence of interstitial lung disease.
- •9. Has an active infection requiring systemic therapy.
- •10. Has a history or current evidence of any condition, 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.
- •11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •12. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- •13. Has received prior therapy with an anti-PD-1, anti-PD-L1, and anti-PD-L2 (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). Subjects with melanoma who previously received treatment with ipilimumab are not excluded.
- •14. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •15. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- •16. Has received a live vaccine within 30 days of planned start of study therapy.
- •17. Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved wi
研究者
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