EUCTR2019-002006-51-DK进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants with Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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. Is male or female and is at least 18 years of age on the day of providing documented informed consent with histologically or cytologically confirmed diagnosis of cTX N+ M0 or cT2-T4a NX M0 ESCC (as defined by AJCC 8th edition), GEJC, EAC, or histologically or cytologically confirmed diagnosis of cTX N+ M1 cervical or upper thoracic esophageal carcinoma with supraclavicular lymph node metastases only, is deemed suitable for dCRT (per requirement in the radiotherapy manual), has disease that is qualitatively evaluable upon radiographic assessment by local site Investigator, and is ineligible for curative surgery based on the documented opinion of a qualified medical/surgical/radiation oncologist.
- •2. Is not be expected to require tumor resection during the course of the
- •3. Has an ECOG performance status of 0 to 1 within 3 days of the first
- •dose of study intervention
- •4. Is adequately nourished and hydrated per the Investigator's judgment. A feeding tube is acceptable to maintain adequate nourishment
- •5. Has provided tumor tissue sample deemed adequate for PD-L1 and MSI biomarker analysis. The PD-L1 result must be determined as positive or negative by the central laboratory and the site notified of its adequacy. Study sites will be masked as to the PDL1 result. A repeat sample will be required if submitted sample is inadequate
- •6. Has adequate organ function. Specimens must be collected within 14 days prior to the start of study treatment
- •7. Male participants are eligible to participate if they agree to the following during the intervention period and through 90 days after the last dose of chemotherapy:
- •- Refrain from donating sperm
- •PLUS either:
- •- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- •- Must agree to use contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause):
- •Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant
- •- If the contraception requirements in the local label for any of the study drugs is more stringent than the requirements above, the local label requirements should be followed.
- •8. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
- •- Is not a Woman of Childbearing Potential (WOCBP)
- •- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period through 180 days after the last dose of chemotherapy or 120 days after the last dose of pembrolizumab, whichever is greater, and agrees not to donate eggs (ova, oocytes) to
- •others or freeze/store for her own use for the purpose of reproduction during this period. The Investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention
- •- A WOCBP must have a negative highly sensitive pregnancy test, urine or serum as required by local regulations, within 24 hours or 72 hours respectively before the first dose of study intervention.
- •The Investigator is responsible for revie
排除标准
- •1. Has direct invasion of tumor into adjacent organs such as the aorta or trachea (participants with T4b disease are not eligible for study participation) or has radiographic evidence of > 90 degree encasement or invasion of a major blood vessel, or of intratumoral cavitation.
- •2. Has had major surgery other than for insertion of a feeding tube, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during study treatment. In addition, participants with gastric or esophageal fistulae are excluded from the trial.
- •3. Has had weight loss of >20% in the previous 3 months
- •4. Has had prior chemotherapy or RT for esophageal cancer
- •5. Has had a myocardial infarction within the past 6 months. If the myocardial infarction occurred >6 months ago, participant may be included if no transient ischemia is evident and at the discretion of the Principal Investigator with input from a cardiologist
- •6. Has symptomatic heart failure (ie, NYHA Class 2 or higher)
- •7. Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase, hearing impairment, etc), therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate (eg, any contraindication to the use of cisplatin, oxaliplatin, leucovorin or 5-FU), in the opinion of the treating Investigator
- •8. Has received prior therapy with an antiPD-1, antiPD-L1, or antiPD-L2
- •agent or with an agent directed to another stimulatory or coinhibitory Tcell
- •receptor (eg, CTLA-4, OX-40, CD137).
- •9. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed.
- •10. Has received any prior systemic anticancer therapy for esophageal cancer including investigational agents
- •11. Has not recovered from all AEs due to previous non-anticancer therapies to =Grade 1 or baseline. Participants with =Grade 2 neuropathy may be eligible
- •12. Is currently participating in or has participated in a study of an investigational agent for a condition or has used an investigational device within 4 weeks prior to the first dose of study intervention
- •13. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
- •14. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- •15. Has severe hypersensitivity (=Grade 3) to pembrolizumab, any of the study chemotherapy agents, or their excipients
- •16. Has an active autoimmune disease that has required systemic treatment in 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) is not considered a form of systemic treatment and is allowed
- •17. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Participant should be excluded if systemic steroids were required
- •18. Has an active infection requiring systemic therapy
- •19. Has a known history of human immunodeficiency virus (HIV)
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