EUCTR2020-005649-17-AT进行中（未招募）1 期
A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab plus Investigational Agents in Combination with Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99) - Phase 2 First-Line ES-SCLC Platform Study
Merck Sharp & Dohme LCC, a subsidiary of Merck & Co., Inc.0 个研究点目标入组 120 人开始时间: 2021年6月30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
- 120
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 or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy
- •2. Has extensive-stage SCLC defined as Stage IV (T any, N any, M1a/b/c)
- •3. Is male or female, at least 18 years of age at the time of providing documented informed consent
- •4. Male participants are eligible to participate if they agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows:
- •- Lenvatinib (7 days)
- •- Etoposide, Cisplatin, or Carboplatin (180 days)
- •- Pembrolizumab, MK-4830, or MK-5890 (no contraception measures)
- •? 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 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. 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 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 the time needed to eliminate each study intervention after the last dose of study intervention 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 length of time required to continue contraception for each study intervention is as follows:
- •- Lenvatinib (30 days)
- •- Etoposide, Cisplatin, or Carboplatin (180 days)
- •- Pembrolizumab, MK-4830, or MK-5890 (120 days)
- •The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study intervention.
- •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.
- •- Has e a negative highly sensitive pregnancy test within 24 hours (urine test) or 72 hours (serum test) before the first dose of study intervention
- •- If a 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
- •- Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention
- •- Has had her medical history, menstrual history a
排除标准
- •1. Has had major surgery within 3 weeks before first dose of study interventions
- •2. Has a preexisting =Grade 3 gastrointestinal or non-gastrointestinal fistula
- •3. Has urine protein =1 g/24 hours
- •4. Has a LVEF below the institutional (or local laboratory) normal range, as determined by MUGA or ECHO
- •5. Prolongation of QTcF interval to >480 ms
- •6. Has clinically significant cardiovascular disease or major arterial thromboembolic event within 12 months before 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
- •7. Has active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks before the first dose of study intervention
- •8. Has gastrointestinal malabsorption or any other condition that might affect oral study intervention absorption
- •9. Has serious nonhealing wound, ulcer, or bone fracture within 28 days before first dose of study intervention
- •10. Has any major hemorrhage or venous thromboembolic events within 3 months before the first dose of study intervention. Participants with venous thrombosis diagnosed more than 3 months before the first dose of study intervention must be on stable doses of anticoagulants
- •11. Has a history of inflammatory bowel disease
- •12. Has a history of a gastrointestinal perforation within 6 months before the first dose of study intervention
- •13. Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome
- •14. 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 T-cell receptor (eg, anti-CTLA-4, anti-OX-40, anti-CD137, anti-CD27)
- •15. Has received prior treatment (chemotherapy, radiotherapy, or surgical resection) including investigational agents for SCLC
- •16. Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study
- •17. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
- •18. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
- •19. Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
- •20. Has symptomatic ascites, pleural effusion, or pericardial effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco-or paracentesis) is eligible
- •21. 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
- •22. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- •23. Has known active CNS metastases and/or carcinomatous meningitis
- •24. Has a history of severe hypersensitivity reaction (= Grade 3) to any study intervention and/or any of its excipients
- •25. Has an active autoimmune disease that has required
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