C4221016 - A Phase 3, Randomized, Double-Blind Study of Encorafenib and Binimetinib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants with BRAF V600E/K Mutation-Positive Metastatic or Unresectable Locally Advanced Melanoma

Pfizer Inc.59 个研究点分布在 11 个国家目标入组 161 人开始时间: 2024年5月29日最近更新: 2025年6月27日

试验速览

阶段: 3 期
状态: 招募中
发起方: Pfizer Inc.
入组人数: 161
试验地点: 59
主要终点: Safety Lead-In: Incidence of DLTs.

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Safety Lead-In: To determine the RP3D of encorafenib and binimetinib when given in combination with pembrolizumab. Randomized Phase 3: To compare the efficacy of encorafenib and binimetinib plus pembrolizumab (Triplet Arm) versus placebo plus pembrolizumab (Control Arm) with respect to OR by BICR assessment.

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 years 至 65+ years（65+ Years, 18-64 Years）
接受健康志愿者: 是

入选标准

•Male or female participants ≥18 years of age at the time of informed consent.
•Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition.
•Documented evidence of a BRAF V600E or V600K mutation
•Submission of adequate tumor tissue for central laboratory testing of BRAF V600E/K mutation is required for all participants during the screening period and prior to enrollment (SLI)/randomization (Phase 3).
•SLI Participants: Have not received more than 1 prior systemic therapy for metastatic or locally advanced melanoma.
•Phase 3 Participants: Have not received prior first-line systemic therapy for metastatic or unresectable locally advanced melanoma.
•Have at least 1 measurable lesion per RECIST v1.
•ECOG PS of 0 or 1, and adequate organ and cardiac function, including LVEF ≥50% by cardiac imaging.

排除标准

•Mucosal or ocular melanoma
•Previous administration with an investigational drug ≤ 6 months prior to enrollment (SLI)/randomization (Phase 3)
•Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment in the past 2 years.
•Clinically significant cardiovascular disease.
•History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to enrollment (SLI)/randomization (Phase 3).
•History or current evidence of RVO or current risk factors for RVO.
•Concurrent neuromuscular disorder that is associated with the potential of elevated CK.
•Any active infection requiring systemic therapeutic treatment within 2 weeks prior to enrollment (SLI)/ randomization (Phase 3).
•Current noninfectious pneumonitis/interstitial lung disease or history of noninfectious pneumonitis/interstitial lung disease requiring steroids, or history of radiation pneumonitis.
•Prior or current symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases.

结局指标

主要结局

Safety Lead-In: Incidence of DLTs.

Randominzed Phase 3: OR, defined as confirmed BOR of either CR or PR, as determined by BICR assessment per RECIST v1.1 from randomization to the earliest of PD, start of subsequent anticancer therapy, or death due to any cause

次要结局

1. Safety Lead-In: Incidence and severity of AEs graded according to the NCI CTCAE v4.03* and changes in clinical laboratory parameters, vital signs, and cardiac assessments.
2. Safety Lead-In: OR, PFS, DC, TTR
3. Safety Lead-In: Plasma concentration-time profiles and PK parameter estimates for encorafenib and binimetinib.
4. Randomized Phase 3: PFS, defined as the time from the date of randomization to the date of first documented disease progression, as determined by BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first.

研究者

发起方

Pfizer Inc.

申办方类型

Pharmaceutical company

责任方

Principal Investigator

主要研究者

Clinical Medical Lead

Scientific

Pfizer Inc.

研究点 (59)

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