UNASSIGNED: Patients ≥18 years with inoperable locally recurrent or metastatic SCAC, measurable disease per RECIST v1.1, and no prior systemic chemotherapy or PD-(L)1-directed therapy will be enrolled and stratified by PD-L1 expression, region, and extent of disease. Patients with well-controlled human immunodeficiency virus infection are eligible. Planned enrollment is approximately 300 patients worldwide, with a 1:1 randomization to retifanlimab or placebo. Patients will receive up to six induction cycles (24 weeks) of carboplatin (area-under-the-curve 5 on day 1) and paclitaxel (80 mg/m2 on days 1, 8, and 15) every 28 days per SOC. Concurrently, retifanlimab 500 mg or placebo will be administered intravenously in a blinded fashion on day 1 of each 28-day cycle for up to 13 cycles (1 year) in the absence of unacceptable toxicity, disease progression, withdrawal of consent, loss to follow-up, or premature discontinuation. Crossover to open-label retifanlimab will be allowed for patients assigned to placebo upon verification of progression by blinded independent central radiographic review (BICR). The primary study endpoint is PFS per RECIST v1.1 by BICR. Secondary endpoints are OS, objective response rate, duration of response, disease control rate, safety, and retifanlimab pharmacokinetics. The study is currently recruiting.
UNASSIGNED: https://clinicaltrials.gov/ct2/show/NCT04472429; https://clinicaltrialsregister.eu/ctr-search/search?query=2020-000826-24.
未经证实:≥18岁不能手术的局部复发或转移性SCAC患者,根据RECISTv1.1可测量的疾病,并且没有先前的全身化疗或PD-(L)1定向治疗将被纳入并通过PD-L1表达进行分层,区域,和疾病的程度。具有良好控制的人类免疫缺陷病毒感染的患者是合格的。计划招募全球约300名患者,1:1随机分为retifanlimab或安慰剂。每个SOC每28天,患者将接受多达六个诱导周期(24周)的卡铂(第1天的曲线下面积为5)和紫杉醇(第1、8和15天的80mg/m2)。同时,retifanlimab500mg或安慰剂将在每个28天周期的第1天以盲法静脉内给药,长达13个周期(1年),在没有不可接受的毒性的情况下,疾病进展,撤回同意,后续损失,或过早停药。在通过盲法独立中央影像学检查(BICR)验证进展后,将允许分配给安慰剂的患者交叉使用开放标签retifanlimab。主要研究终点是BICR根据RECISTv1.1的PFS。次要端点是OS,客观反应率,响应的持续时间,疾病控制率,安全,和retifanlimab药代动力学。该研究目前正在招募中。
UNASSIGNED:https://clinicaltrials.gov/ct2/show/NCT04472429;https://clinicaltrialsregister。eu/ctr-search/search?query=2020-000826-24.