EUCTR2021-005135-23-PT进行中（未招募）1 期
Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab with Pembrolizumab) in Combination with Concurrent Chemoradiotherapy followed by MK-7684A Versus Concurrent Chemoradiotherapy followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III NSCLC (KEYVIBE-006) - A Phase 3 study of MK-7684A plus cCRT in Stage III NSCLC
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.0 个研究点目标入组 784 人开始时间: 2022年4月4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
- 784
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Has pathologically confirmed diagnosis of NSCLC
- •2. Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
- •3. Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
- •4. Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body FDGPET or FDG-PET/CT and CT or MRI scans of diagnostic quality of chest, abdomen, pelvis and brain
- •5. Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review
- •6. Has not received prior treatment for their Stage III NSCLC
- •7. Has provided tumor tissue sample. FFPE blocks are preferred to slides
- •8. Has an ECOG Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
- •9. Has a life expectancy of at least 6 months
- •10. Has adequate PFT defined as a FEV1 >50% of predicted normal volume and the carbon monoxide lung diffusing capacity (DLCO) >40% of predicted normal value. Participants for whom DLCO measurements are not available will be deemed to have adequate oxygen transfer if pulse oximetry (O2 saturation) is determined to be =90% on room air
- •11. Is male or female, at least 18 years of age inclusive, at the time of providing informed consent
- •12. 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:
- •- Chemotherapy platinum doublet: 95 days
- •- Radiotherapy: 90 days
- •Refrain from donating sperm
- •PLUS either:
- •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. 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
- •13. 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:
- •- 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 of study intervention and agrees not to donate eggs 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:
- •?Chemotherapy platinum doublet: 180 days
- •?Radiotherapy: 180 days
- •?MK-7684A: 120 days
- •?Durvalumab: 90 days
- •The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of st
排除标准
- •1. Has SCLC or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible
- •2. Is likely to have a radiation treatment plan that will encompass a volume of whole lung (total lung-GTV) receiving =20 Gy in total (lung V20) of more than 34% of whole lung volume
- •3. Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
- •4. Has 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)
- •5. Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization
- •6. Is expected to require any other form of antineoplastic therapy, while on study
- •7. Has received colony-stimulating factors (e.g., G-CSF, GM-CSF, or recombinant erythropoietin) within 28 days prior to the first dose of study intervention
- •8. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
- •Pemetrexed-specific Criteria
- •9. Is unable to interrupt aspirin or other NSAIDs, other than an aspirin dose =1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed
- •10. Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone
- •11. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention
- •12. 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 medication
- •13. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- •14. Has severe hypersensitivity (= Grade 3) to MK-7684A, platinum doublet components, durvalumab and/or any of its excipients
- •15. Active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
- •16. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •17. Has an active infection requiring systemic therapy
- •18. Has a known history of HIV infection. No HIV testing is required unless mandated by local health authority
- •19. 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
- •20. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •21. Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
- •22. In the opinion of the treating investigator, 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 ventricular arrhythmia, recent (within 3 month
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