EUCTR2020-005628-12-PL进行中（未招募）1 期
A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination with Investigational Agents for the Treatment of Participants With PD-1/L1- refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy (KEYNOTE-B98) - Phase 1b/2 Second-Line ES-SCLC Platform Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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 second-line therapy
- •2. Participants must have progressed on or after treatment with an anti-PD-1/L1 mAb administered as part of first-line platinum-based systemic therapy for ES-SCLC. PD-1/L1 checkpoint inhibitor treatment progression is defined by meeting ALL of the following criteria:
- •a. Has received at least 2 doses of an anti-PD-1/L1 mAb
- •b. Has demonstrated radiographic disease progression during or after an anti-PD-1/L1 mAb as defined by investigator
- •c. Disease progression has been documented within 12 weeks from the last dose of an anti-PD-1/L1 mAb
- •3. Has extensive-stage SCLC defined as Stage IV by the American Joint Committee on Cancer, Eighth Edition
- •4. Has received 1 prior line of systemic therapy for SCLC. Study intervention will treat second-line ES-SCLC
- •5. Is male or female, at least 18 years of age at the time of providing documented informed consent
- •6. 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
- •- Pembrolizumab, MK-1308A, MK-4830, MK-4280A – no contraception measures required
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent
- •Must agree to use contraception unless confirmed to be azoospermic 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
- •7. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Not a WOCBP
- •A WOCBP and:
- •- Uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the intervention period and for at least the time needed to eliminate each study intervention after the last dose. The length of time required to continue contraception for each study intervention is as follows:
- •- Lenvatinib – 30 days
- •- Pembrolizumab, MK-1308A, MK-4830, MK-4280A – 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 a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention
- •- Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention (Pembrolizumab, MK-
- •1308A, MK-4830, MK-4280A) and 7 days from last dose of lenvatinib administration, whichever is last.
- •- Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk
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 the start of study intervention
- •10. Has any major hemorrhage or venous thromboembolic events within 3 months before the start of study intervention. Participants with venous thrombosis diagnosed more than 3 months before the start 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 start of study intervention
- •13. Has a known history of, or active, neurologic paraneoplastic syndrome
- •14. Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease
- •15. Has received prior therapy with an RTK inhibitor or anti-CTLA-4, anti-ILT-4, or anti- LAG-3 agents
- •16. Has received prior therapy with an anti-PD-1/L1 agent and was permanently discontinued from that treatment due to a treatment-related AE
- •17. Has received prior systemic anticancer therapy including investigational agents within 4 weeks before start of study intervention
- •18. 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
- •19. Has received lung radiation therapy >30 Gy within 6 months before the first dose of study intervention
- •20. Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
- •21. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- •22. Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
- •23. Has symptomatic ascites, pleural effusion, or pericardial effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoracoor paracentesis) is eligible
- •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 required active treatment within the past 3 years
- •26. Has known active CNS metastases an
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