EUCTR2020-004087-26-HU进行中（未招募）1 期
A Phase 2, Single-arm, Open-label Clinical Trial of Pembrolizumab Plus Lenvatinib in Participants with First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (nccRCC) (KEYNOTE-B61) - Pembro + Lenva for 1L nccRCC
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 152 人开始时间: 2020年11月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 152
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 a centrally confirmed diagnosis of non-clear cell RCC.
- •2. Has locally advanced/metastatic disease (ie, Stage IV per the American Joint Committee on Cancer).
- •3. Has received no prior systemic therapy for advanced nccRCC.
- •4. Is male or female, from 18 years to 120 years of age inclusive, at the time of signing the informed consent.
- •5. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 5 days after the last dose of study intervention)]:
- •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 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.
- •Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Please note that 5 days after lenvatinib is stopped, if the male participant is on pembrolizumab only, no male contraception measures are needed.
- •6. 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, 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] as required 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.
- •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •7. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study.
- •8. Has measurable disease per RECIST 1.1 as assessed by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •9. Has submitted an archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. FFPE tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- •10. Has KPS =70% as assessed within 10 days prior to the start of study intervention.
- •11. Has adequately controlled BP with or without antihypertensive medications, defi
排除标准
- •1. Has collecting duct histology.
- •2. A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study intervention. If the urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •3. Has preexisting =Grade 3 gastrointestinal or non-gastrointestinal fistula.
- •4. Has urine protein =1 g/24 hours.
- •5. Has a left ventricular ejection fraction below the institutional (or local laboratory) normal range, as determined by multigated acquisition or echocardiogram.
- •6. Has radiographic encasement or invasion of a major blood vessel, or of intratumoral cavitation.
- •7. Has prolongation of QTcF interval to >480 msec.
- •8. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
- •9. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.
- •10. Has active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug
- •11. Has had major surgery within 3 weeks prior to first dose of study intervention.
- •12. 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 co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- •13. Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to allocation.
- •14. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
- •15. Has received a live or attenuated vaccine within 30 days before the first dose of study intervention.
- •16. 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.
- •17. 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.
- •18. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •19. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
- •20. Has severe hypersensitivity (=Grade 3) to pembrolizumab, lenvatinib and/or any of their excipients.
- •21. 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 t
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