2022-501254-10-00招募中3 期
A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants who are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,133
- 试验地点
- 200
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
To estimate the overall survival (OS)
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Overall trial
- 盲法
- None
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
- 是
入选标准
- •Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready
- •(Criteria for dosing with lenvatinib) Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse
- •Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase
- •(Applicable to Second Course Phase only) Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase
- •(Applicable to Second Course Phase only) Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •(Applicable to Second Course Phase only) Demonstrates adequate organ function
- •(Applicable to Second Course Phase only) Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
- •(Applicable to Second Course Phase only) A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.
- •(Criteria for dosing with lenvatinib) Adequately controlled blood pressure (BP) to <150/90 mmHg, with or without antihypertensive medications
- •(Criteria for dosing with lenvatinib) For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib
排除标准
- •(Applicable to Second Course Phase only) Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
- •(Applicable to Second Course Phase only) Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
- •(Applicable to Second Course Phase only) Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment
- •(Applicable to Second Course Phase only) 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 to the Cycle 1 Day 1 of Second Course Phase
- •(Applicable to Second Course Phase only) Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
- •(Applicable to Second Course Phase only) Has known active central nervous system metastases and/or carcinomatous meningitis
- •(Applicable to Second Course Phase only) Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- •(Applicable to Second Course Phase only) Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
- •(Applicable to Second Course Phase only) Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease
- •(Applicable to Second Course Phase only) Has an active infection requiring systemic therapy
- •(Criteria for dosing with lenvatinib) Has had major surgery within 3 weeks prior to first dose of study intervention(s)
- •(Applicable to Second Course Phase only) Has a known history of human immunodeficiency virus (HIV) infection
- •(Criteria for dosing with lenvatinib) Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
- •(Criteria for dosing with lenvatinib) Has urine protein ≥1 g/24 hours
- •(Criteria for dosing with lenvatinib) Has LVEF below the institutional (or local laboratory) normal range, as determined by MUGA or ECHO
- •(Criteria for dosing with lenvatinib) Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
- •(Criteria for dosing with lenvatinib) Prolongation of QTcF interval to >480 ms
- •(Criteria for dosing with lenvatinib) 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
- •(Criteria for dosing with lenvatinib) Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
- •(Criteria for dosing with lenvatinib) Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug
- •(Criteria for dosing with lenvatinib) Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib
- •(Applicable to Second Course Phase only) Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.
- •(Applicable to Second Course Phase only) Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
- •(Applicable to Second Course Phase only) Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease
- •(Applicable to Second Course Phase only) Has hepatic decompensation (Child-Pugh score >6 [class B and C])
- •(Applicable to Second Course Phase only) Has uncontrolled thyroid dysfunction
- •(Applicable to Second Course Phase only) Has uncontrolled diabetes mellitus
- •(Applicable to Second Course Phase only) Has had an allogeneic tissue/solid organ transplant
研究组 & 干预措施
favezelimab
Experimental
Participants receiving favezelimab
干预措施: favezelimab (Drug)
结局指标
主要结局
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Modified Progression Free Survival (PFS) Per Evaluation Criteria Used in the Parent Trial
- Modified Event Free Survival (EFS) Per Evaluation Criteria Used in the Parent Trial
- Number of Participants Who Experience Serious Adverse Events (SAEs)
- Number of Participants Who Experience Adverse Events of Special Interest (AEOSI)
- Number of Participants Who Experience Clinically Significant Adverse Events (CSAE)
- Number of Participants Who Experience Events of Clinical Interest (ECI)
- Number of Participants Who Discontinue Study Treatment Due to an AE
研究者
Rohit Lal
Scientific
Merck Sharp & Dohme LLC
研究点 (200)
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