EUCTR2020-001990-53-BE进行中（未招募）1 期
A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) plus Pembrolizumab (MK-3475) plus Chemotherapy Compared with Standard of Care Therapy as First-line Intervention in Participants with Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 790
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.Has histologically and/or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic gastroesophageal adenocarcinoma
- •2.Is not expected to require tumor resection during the treatment course
- •3.Has gastroesophageal adenocarcinoma that is not HER-2/neu positive
- •4.Has measurable disease as defined by RECIST 1.1 by scan with IV contrast as determined by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions since the completion of radiation (by scans with contrast)
- •5.Is male or female at least 18 years of age inclusive, at the time of signing the informed consent
- •6.Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after last dose of lenvatinib or 90 days after last dose of chemotherapy, whichever comes last:
- •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
- •- Please note that 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only, no male contraception measures are needed
- •7.A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Is not a 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 120 days after last dose of pembrolizumab, 30 days after last dose of lenvatinib, or 180 days after last dose of chemotherapy whichever occurs last, or not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
- •A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours for urine or 72 hours for serum before the first dose of study intervention
- •8.The participant (or legally acceptable representative) has provided documented informed consent/assent for the study
- •9.Has a performance status of 0 or 1 on the ECOG Performance Scale within 3 days prior to the first dose of study treatment
- •10.Has provided a tumor tissue sample for PD-L1 and MSI biomarker analysis. If the initial tissue is inadequate for the analysis, an additional specimen will need to be provided
- •11.Has adequately controlled BP with or without antihypertensive medications, defined as BP =150/90 mm Hg and no change in antihypertensive medications within 1 week prior to randomization
- •12.Has adequate organ function. Specimens must be collected within 10 days prior to the start of study intervention
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this a
排除标准
- •1.Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ//esophageal adenocarcinoma
- •2.Has had major surgery within 28 days prior to first dose of study interventions
- •3.Has had radiotherapy within 14 days of randomization.
- •4.Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- •5.Has known CNS metastases and/or carcinomatous meningitis
- •6.Has severe hypersensitivity (=Grade 3) to treatment with an mAb or known sensitivity or intolerance to any component of lenvatinib, pembrolizumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum containing products
- •7.Has had an allogeneic tissue/solid organ transplant
- •8.Has perforation risks or significant GI bleeding, such as:
- •-Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to randomization
- •-Has preexisting =Grade 3 GI or non-GI fistula
- •-Has significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to randomization
- •9.Has GI obstruction, poor oral intake (CAPOX participants), or difficulty in taking oral medication (CAPOX participants)
- •10.Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory TCR
- •11.Has received prior therapy with anti-VEGF TKI or anti-VEGF mAb
- •12.Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug
- •13.Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
- •14.Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy is not considered a form of systemic treatment and is allowed
- •15.Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
- •16.Has inadequate cardiac function assessed as:
- •-LVEF below the institutional normal range as determined by a MUGA or ECHO
- •-QTcF value >470 msec for males and >480 msec for females
- •17.Has urine protein =1 g/24 hours
- •18.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 to the first dose of study intervention
- •19.Has a history of (noninfectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •20.Has a known history of active TB (Mycobacterium tuberculosis)
- •21.Has an active infection requiring systemic therapy
- •22.Has poorly controlled diarrhea (eg, watery stool, uncontrollable bowel movement with supportive medication, Grade =2 and number of defecations, =5/day)
- •23.Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment
- •24.Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the investigator. Participants with a contraindication to SOC therapy should be excluded based on the following:
- •-Has a history of a GI condition or procedure that
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