EUCTR2021-004564-94-PL进行中（未招募）1 期
A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants with Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007) - A Phase 3 study of MK-7684A in combination with chemotherapy in metastatic NSCLC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
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 histologically or cytologically confirmed diagnosis of Stage IV (T any, N any, M1a, M1b, M1c - AJCC eighth Edition) squamous or nonsquamous NSCLC
- •2. Has measurable disease based on RECIST 1.1, as determined by the local site assessment
- •3. Has provided tumor tissue (post diagnosis of metastatic disease is preferred) for determination of PD-L1 status before randomization
- •4. Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of the absence of tumor-activating EGFR mutations [eg, DEL19 or L858R], AND absence of ALK and ROS1 gene rearrangements OR presence of KRAS mutation)
- •5. Has not received prior systemic treatment for metastatic NSCLC
- •6. Is male or female, from =18 years of age inclusive, at the time of signing the informed consent
- •7. Has an ECOG PS of 0 or 1 assessed within 7 days before randomization
- •8. Has a life expectancy of at least 3 months
- •9. If male, agrees 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:
- •Chemotherapy: at least 95 days from the last dose
- •Refrain from donating sperm
- •PLUS either:
- •Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent
- •Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause), documented from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview as detailed below:
- •- Uses 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
- •10. 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
- •Is a WOCBP and:
- •- Uses 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:
- •? MK-7684A/pembrolizumab: 120 days
- •? Chemotherapy: 180 days
- •- The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) 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 inter
排除标准
- •1. Known additional malignancy that is progressing or has required active treatment within the past 3 years
- •2. 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 as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention. Participants with asymptomatic brain metastases (ie, no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesion >1.5 cm) may participate
- •3. Severe hypersensitivity (=Grade 3) to MK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its excipients
- •4. 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 before the first dose of study medication
- •5. Active autoimmune disease that has required systemic treatment in past 2 years , except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
- •6. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •7. Active infection requiring systemic therapy
- •8. Known history of HIV infection. No HIV testing is required unless mandated by local health authority
- •9. Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
- •10. History or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •11. Known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
- •12. Received prior therapy with an anti-TIGIT, 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, CTLA-4, OX-40, CD137)
- •13. Received prior systemic anticancer therapy for metastatic disease
- •14. If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
- •15. Received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis
- •16. Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention
- •17. 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 unable to interrupt aspirin or other NSAIDs, other than an aspirin dose =1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
- •19. Is unable or unwilling to take folic acid or vitamin B12 supplementation
- •20. 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 interve
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