EUCTR2019-003717-34-DE进行中（未招募）1 期
A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pembrolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010).
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
- 500
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 confirmed diagnosis of R/M HNSCC that is
- •considered incurable by local therapies.
- •2. Has a primary tumor location of oropharynx, oral cavity, hypopharynx,
- •3. Is male or female, and at least 18 years of age at the time of
- •documented informed consent.
- •Male Participants
- •Contraceptive use by men should be consistent with local regulations
- •regarding the methods of contraception for those participating in clinical
- •studies. If the contraception requirements in the local label for any of
- •the study interventions is more stringent than the requirements above,
- •the local label requirements are to be followed.
- •4. Male participants are eligible to participate if they agree to the
- •following during the intervention period and for at least 7 days after the
- •last dose of lenvatinib/placebo:
- •- Be abstinent from heterosexual intercourse as their preferred and
- •usual lifestyle (abstinent on a long term and persistent basis) and agree
- •to remain abstinent, or
- •- Must agree to use contraception unless confirmed to be azoospermic
- •(vasectomized or secondary to medical cause) as detailed below:
- •- 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.
- •Female Participants
- •Contraceptive use by women should be consistent with local regulations
- •regarding the methods of contraception for those participating in clinical
- •studies. If the contraception requirements in the local label for any of
- •the study interventions is more stringent than the requirements above,
- •the local label requirements are to be followed.
- •5. 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 and for at least 120 days post pembrolizumab or 30
- •days post lenvatinib/placebo whichever occurs last. 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 asrequired by local regulations) within 24 hours before the
- •first dose of study intervention.
- •- If a urine test cannot be confirmed as negative (eg, an ambiguous
- •result), a serum pregnancy test is required. In such cases, the
- •participant must be excluded from participation if the serum pregnancy
- •result is positive.
- 另有 10 项未显示
排除标准
- •1. Has any evidence of symptoms or signs of active tumor bleeding within 6 months before randomization.
- •2. Has radiographic evidence of major blood vessel invasion/infiltration
- •or tumor demonstrates >90 degree abutment or encasement of a major
- •blood vessel.
- •3. Has a history of re-irradiation to any head and neck sites of disease
- •including the cervical, infraclavicular or supraclavicular lymph nodes for
- •head and neck cancer.
- •4. Has ulceration and/or fungation of disease onto the skin surface.
- •5. Has a life expectancy of less than 3 months and/or has rapidly
- •progressing disease (eg, uncontrolled tumor pain) in the opinion of the
- •treating investigator.
- •6. Has a history of any contraindication or has a severe hypersensitivity
- •to any components of pembrolizumab (=Grade 3) or lenvatinib.
- •7. Has pre-existing =Grade 3 gastrointestinal or non-gastrointestinal
- •8. Has a history of a gastrointestinal condition or procedure that, in the
- •opinion of the investigator, may affect oral study drug absorption.
- •9. Has clinically significant cardiovascular impairment within 12 months
- •of the first dose of study intervention.
- •10. Has disease that is suitable for local therapy administered with
- •curative intent.
- •11. Had PD within 6 months of completion of curatively intended
- •systemic treatment for locoregionally advanced HNSCC.
- •12. Has had major surgery within 3 weeks before first dose of study
- •interventions.
- •13. Has difficulty swallowing capsules or ingesting a suspension orally or
- •by a feeding tube.
- •14. Has received prior therapy with lenvatinib or pembrolizumab.
- •15. Received last dose of systemic therapy for locoregionally advanced
- •disease less than 6 months before signing consent
- •16. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PDL2
- •agent or with an agent directed to another stimulatory or coinhibitory
- •T-cell receptor (eg, CTLA-4, OX- 40, CD137).
- •17. Has received prior systemic anticancer therapy including
- •investigational agents within 4 weeks before randomization.
- •18. Has received prior radiotherapy within 2 weeks of start of study
- •intervention.
- •19. Has received a live vaccine within 30 days before the first dose of
- •study intervention. Administration of killed vaccines is allowed.
- •20. Has received an investigational agent or has used an investigational
- •device within 4 weeks prior to study intervention.
- •21. Has urine protein =1 g/24 hours.
- •22. Has prolongation of QTc interval (calculated using Fridericia's
- •formula) to >480 msec.
- •23. Has a LVEF below the institutional (or local laboratory) normal
- •range, as determined by MUGA or ECHO.
- •24. 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 intervention.
- •25. Has a known additional malignancy that is progressing or has
- 另有 10 项未显示
研究者
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