PER-044-19招募中未知
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).
Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,0 个研究点目标入组 1 人开始时间: 2020年6月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 1
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
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, or larynx
- •3. Is male or female, and at least 18 years of age at the time of signing the informed consent
- •4. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 30 days after the last dose of lenvatinib/placebo:
- •-Be abstinent from heterosexual intercourse as their preferred and usual lifestyle
- •-Must agree to use contraception
- •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
- •6. The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study
- •7. Has measurable disease per RECIST 1.1 as assessed by BICR
- •8. Has provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. FFPE tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue
- •9. Has a PD-L1 positive (CPS ≥1) tumor as determined by the central laboratory
- •10. Participants with oropharyngeal cancer must have results from testing of HPV status defined as p16 IHC testing using CINtec® p16 Histology assay and a 70% cutoff point. If HPV status was previously tested using this method, no additional testing is required
- •11. Has an ECOG performance score of 0 to 1
- •12. Has adequately controlled BP with or without antihypertensive medications, defined as BP ≤150/90 mm Hg with no change in antihypertensive medications within 1 week prior to randomization
- •13. Has adequate organ function as defined in the following table (Table 3, see Protocol). Specimens must be collected within 7 days prior to the start of study intervention.
- •Please refer to the protocol for more information
排除标准
- •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, or larynx
- •3. Is male or female, and at least 18 years of age at the time of signing the informed consent
- •4. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 30 days after the last dose of lenvatinib/placebo:
- •-Be abstinent from heterosexual intercourse as their preferred and usual lifestyle
- •-Must agree to use contraception
- •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
- •6. The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study
- •7. Has measurable disease per RECIST 1.1 as assessed by BICR
- •8. Has provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. FFPE tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue
- •9. Has a PD-L1 positive (CPS ≥1) tumor as determined by the central laboratory
- •10. Participants with oropharyngeal cancer must have results from testing of HPV status defined as p16 IHC testing using CINtec® p16 Histology assay and a 70% cutoff point. If HPV status was previously tested using this method, no additional testing is required
- •11. Has an ECOG performance score of 0 to 1
- •12. Has adequately controlled BP with or without antihypertensive medications, defined as BP ≤150/90 mm Hg with no change in antihypertensive medications within 1 week prior to randomization
- •13. Has adequate organ function as defined in the following table (Table 3, see Protocol). Specimens must be collected within 7 days prior to the start of study intervention.
- •Please refer to the protocol for more information
- •Criterios de Exclusion claves (Ingles):
- •1. Has any evidence of symptoms or signs of active tumor bleeding within 6 months prior to 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 history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab (≥Grade 3) or lenvatinib
- •6. Has pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
- •7. Has a history of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption
- •8. Has clinically significant cardiovascular impairment within 12 months of the first dose of study drug, such as history of congestive heart failure greater than NYHA Class II, unstable angina, myocardial infarction or cerebrovascular accident/TIA/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability
- •9. Has disease that is suitable for local therapy administered with curative
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