EUCTR2020-005628-12-IT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
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 80 人开始时间: 2021年7月9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
- 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
- •For more Inclusion criteria please see the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
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 treatmentrelated 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. 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
- •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
- •For more exclusion criteria please see the protocl
研究者
相似试验
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)Extensive-Stage Small Cell Lung CancerEUCTR2020-005628-12-PLMerck Sharp & Dohme LLC80
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)MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Extensive-Stage Small Cell Lung CancerEUCTR2020-005628-12-HUMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.80
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)Participants with extensive-stage small cell lung cancerMedDRA version: 21.1Level: PTClassification code: 10041068Term: Small cell lung cancer extensive stage Class: 100000004864CTIS2023-507687-38-00Merck Sharp & Dohme LLC80
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)MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Extensive-Stage Small Cell Lung CancerEUCTR2020-005628-12-ATMerck Sharp & Dohme LLC80
进行中（未招募）
1 期
Efficacy and safety of niraparib in combination with cabozantinib in patients with advanced urothelial cancer.EUCTR2017-004367-12-ESFundación CRIS de investigación para vencer el cáncer71