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

Merck Sharp & Dohme LLC200 个研究点分布在 4 个国家目标入组 1,133 人2022年12月14日

干预措施favezelimab

概览

阶段: 3 期
干预措施: favezelimab
疾病 / 适应症: 未指定
发起方: Merck Sharp & Dohme LLC
入组人数: 1133
试验地点: 200
主要终点: Overall Survival (OS)
状态: 招募中
最后更新: 去年

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

To estimate the overall survival (OS)

注册库

euclinicaltrials.eu

开始日期

2022年12月14日

结束日期

待定

最后更新

去年

研究者

发起方

Merck Sharp & Dohme LLC

责任方

Principal Investigator

主要研究者

Rohit Lal

Scientific

Merck Sharp & Dohme LLC

入排标准

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

研究组 & 干预措施

favezelimab

Participants receiving favezelimab

干预措施: favezelimab

结局指标

主要结局

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