2024-517232-22-00招募中3 期
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 49
- 主要终点
- Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
研究概览
简要总结
- To evaluate the safety and tolerability of treatment with MK-1084, cetuximab, and mFOLFOX6
- To compare MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to PFS per RECIST 1.1 as assessed by blinded independent central review (BICR)
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 diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer [AJCC] eighth edition) colorectal adenocarcinoma
- •Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer
- •Tumor tissue demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
- •Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- •Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
- •Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
排除标准
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, chronic diarrhea)
- •Has history of stem cell/solid organ transplant
- •Has not adequately recovered from major surgery or have ongoing surgical complications.
- •Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- •Has known dihydropyrimidine dehydrogenase (DPD) deficiency
- •HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- •Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
- •Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab
- •Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease
- •Has active infection requiring systemic therapy
结局指标
主要结局
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
Part 1: Number of Participants Who Experience an Adverse Event (AE)
Part 1: Number of Participants Who Experience an Adverse Event (AE)
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Progression-free Survival (PFS)
Progression-free Survival (PFS)
次要结局
- Objective Response Rate (ORR)
- Overall Survival (OS)
- Duration of Response (DOR)
- Part 2: Number of Participants Who Experience an AE
- Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
- Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
- Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Score
- Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Score
- Change from Baseline in the EORTC-QLQ-C30 Appetite Loss (Item 13) Score
- Change from Baseline in the EORTC-Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score
- Time to First 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) Score
- TTD in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Score
- TTD in EORTC QLQ-C30 Appetite Loss (Item 13) Score
- TTD in EORTC QLQ-CR29 Bloating (Item 37) Score
研究者
David Fogelman
Scientific
Merck Sharp & Dohme LLC
研究点 (49)
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