2024-511043-25-00已完成3 期
A Phase 3 study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 positive Colorectal Cancer (KEYFORM-007)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 15
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
- To compare MK-4280A to standard of care (regorafenib or TAS-102) with respect to overall survival.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable.
- •Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the local site investigator.
- •Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment.
- •Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated.
- •Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 10 days prior to first dose of study intervention.
- •Has a life expectancy of at least 3 months, based on the investigator assessment.
- •Has the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption.
- •Has adequate organ function.
排除标准
- •Has previously been found to have deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumor status.
- •Has received prior systemic anticancer therapy including investigational agents within 28 days before randomization.
- •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.
- •Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- •Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- •Has an active autoimmune disease that has required systemic treatment in past 2 years.
- •Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •Has an active infection requiring systemic therapy (eg, tuberculosis, known viral or bacterial infections, etc.).
- •Has a known history of human immunodeficiency virus (HIV) infection.
- •Has known history of Hepatitis B or known active Hepatitis C virus infection.
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease.
- •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.
- •Has had an allogenic tissue/solid organ transplant.
- •Has a history of acute or chronic pancreatitis.
- •Has neuromuscular disorders associated with an elevated creatine kinase (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
- •Has clinically significant cardiovascular disease within 12 months from 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.
- •Has urine protein greater than or equal to 1g/24h.
- •A woman of childbearing potential who has a positive urine/serum pregnancy test within 24/72 hours prior to the first dose of study intervention.
- •Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation [CD] 137).
- •Has previously received regorafenib or TAS-102.
结局指标
主要结局
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Progression-Free Survival (PFS) according per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
- Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
- Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
- Number of Participants Who Experience at least One Adverse Event (AE)
- Number of Participants Who Discontinue Study Treatment Due to an AE
- Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
- Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
- Change from Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score
- Change from Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score
- Time to Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
- TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
- TTD in EORTC QLQ-C30 Appetite Loss (Item 13) Score
- TTD in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score
研究者
David Fogelman
Scientific
Merck Sharp & Dohme LLC
研究点 (15)
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