CTIS2023-505606-42-00进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Ficlatuzumab in Combination with Cetuximab in Participants with Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma (FIERCE-HN) - AV-299-23-301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 410
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Male or female and = 18 years of age, 8. Clinical laboratory values meeting the following criteria prior to randomization: a. Serum creatinine clearance > 30 mL/min, using Cockcroft and Gault formula b. Total bilirubin = 1.5 × upper limit of normal (ULN) (< 3 × upper limit of normal for Gilbert’s disease) c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN, or AST and ALT = 5 × ULN if there are liver metastases d. Activated partial thromboplastin time (aPTT) = 1.5 × ULN and prothrombin time/international normalized ratio (PT/INR) = 1.5 × ULN if not on anticoagulation therapy. Participants receiving anticoagulation therapy with an agent such as warfarin, low–molecular weight heparin, or a direct oral anticoagulant (DOAC) may be allowed to participate if the participant is on a stable (= 2 weeks) dose of anticoagulant and coagulation test results are in the therapeutic range established prior to initiation of study treatment e. Hematologic function: i. Absolute neutrophil count (ANC) = 1200 cells/µL ii. Hemoglobin = 9 g/dL or 5.6 mmol/L. (Note: The use of transfusion or other intervention to achieve Hgb = 9.0 g/dL is acceptable). iii. Platelet count = 75,000/µL, 9. For women of childbearing potential (WOCBP), documentation of negative serum pregnancy test within 30 days of randomization, 10. For WOCBP and male participants whose sexual partners are of childbearing potential, agreement to use an effective method of contraception during the study and for at least 5 months after the last dose of study treatment. Birth control methods which may be considered highly effective include methods that achieve a failure rate of less than 1% per year when used consistently and correctly., 6.The patient’s tumor is considered inoperable and incurable in the opinion of the Investigator., 11. Ability to give written informed consent and comply with protocol requirements, 12. Patients with feeding tubes are eligible for the study., 13. Archived tissue sample must be submitted to the Sponsor-designated laboratory within 60 daysof randomization for c-Met/HGF analysis a. If a tissue sample is not available, the reason should be clearly documented and discussed with the Medical Monitor, 2. Histologically and/or cytologically confirmed primary diagnosis of R/M HNSCC a.Primary tumor locations of oropharynx (p16 negative), oral cavity, hypopharynx, or larynx, 3. Participants with oropharyngeal cancer will be required to have proof of HPV-negative status submitted on the basis of a pathology report a.If HPV status is not known, it is recommended that sites use archived tissue for HPV analysis in participants with oropharyngeal cancer. A report of this analysis must be submitted to confirm HPV-negative status, 4. At least 1 measurable lesion by contrast CT or MRI scan according to RECIST v.1.1. Such lesions must not have been previously irradiated; if the measurable lesion(s) has been irradiated, clear progression must be documented, 5. Participants must have failed prior therapy with an anti-PD-1/PD-L1 ICI and with platinum-based chemotherapy administered in combination or sequentially, in either the locally advanced or R/M setting. Failure of prior treatment may be due to progression of disease or intolerance to treatment (if treatment failure was due to intolerance, the patient must have experienced documented progression of disease since the cessation of prior therapy), 7. Eastern Cooperative Oncology Group (ECOG) performa
排除标准
- •1. Participants may not have received >2 prior lines of anticancer therapy or prior treatment with cetuximab/alternative EGFR inhibitors for the treatment of R/M HNSCC a. Cetuximab/EGFR inhibitors in the adjuvant setting are not allowed b. Cetuximab/EGFR inhibitors for the treatment of locally advanced HNSCC is allowed as long as disease recurrence was at least 6 months after the completion of cetuximab/EGFR treatment. c. Participants who progressed within 6 months after treatment with a platinum-based therapy for locally advanced HNSCC will be considered to have received 1 prior line of treatment for R/M HNSCC., 4. Known untreated and uncontrolled brain metastases or leptomeningeal carcinomatosis Note: Participants with locally treated brain metastases are eligible provided 2 weeks have elapsed since local therapy. Participants are allowed to continue steroid taper during the start of study treatment., 5. Prior treatment with any other investigational drug or biologic agent before a washout has been completed (must be completed prior to randomization): a. 2 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors b. 3 weeks (21 days) or 5 half-lives, whichever is shorter, for antibody-drug conjugates c. 4 weeks (28 days) for cell therapies, 6. Any unresolved and significant toxicity (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) Grade > 2 from previous anticancer therapy (including radiation therapy), other than alopecia, 7. Active tumor-related bleeding within the last 30 days, 8. Significant cardiovascular disease, including: a. Echocardiogram (ECHO) showing left ventricular ejection fraction of less than 50% b. Cardiac failure New York Heart Association class III or IV c. Myocardial infarction, severe or unstable angina within 6 months prior to randomization d. History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) e. Significant thrombotic or embolic events within 3 months prior to randomization (significant thrombotic or embolic events include, but are not limited to, stroke or transient ischemic attack). Participants with catheter-related thrombosis, asymptomatic deep vein thrombosis, or asymptomatic pulmonary embolism are not excluded f. Any uncontrolled or severe cardiovascular disease, such as uncontrolled high blood pressure, in the opinion of the Investigator, 9. Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the participant’s involvement in the study or interfere with the interpretation of study results, 13.Treatment with any live or attenuated vaccine within 30 days prior to the first dose of study therapy., 14.Participants must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive), indicating acute or chronic infection. However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B). NOTE: HBV positive is defined as the presence of hepatitis B surface antigen and/or hepatitis B core antibodies with detectable HBV DNA (=10IU/ml); HCV positive is defined as the presence of anti-HCV antibodies., 10. History of prior malignancy within 2 years prior to randomization (excep
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