临床试验/NCT03126110

NCT03126110已完成1 期

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Incyte Biosciences International Sàrl38 个研究点分布在 4 个国家目标入组 145 人开始时间: 2017年4月25日最近更新: 2025年8月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Incyte Biosciences International Sàrl
入组人数: 145
试验地点: 38
主要终点: Phase 2: Objective Response Rate (ORR) Per RECIST v1.1

研究概览研究设计入排标准研究组 & 干预措施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

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
•Phase 1: Subjects with advanced or metastatic solid tumors.
•Phase 1: Subjects who have disease progression after treatment with available therapies.
•Phase 2: Subjects with advanced or metastatic cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma.
•Presence of measurable disease based on RECIST v1.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

排除标准

•Laboratory and medical history parameters not within the Protocol-defined range
•Prior treatment with any tumor necrosis factor super family agonist.
•Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
•Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
•Active autoimmune disease.
•Known active central nervous system metastases and/or carcinomatous meningitis.
•Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
•Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
•Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).

研究组 & 干预措施

Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W

Experimental

Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.

干预措施: INCAGN01876 (Drug)

Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W

Experimental

Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.

干预措施: Nivolumab (Drug)

Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W

Experimental

Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: INCAGN01876 (Drug)

Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W

Experimental

Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: Nivolumab (Drug)

Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W

Experimental

Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: INCAGN01876 (Drug)

Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W

Experimental

Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: Nivolumab (Drug)

Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W

Experimental

Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: INCAGN01876 (Drug)

Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W

Experimental

Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: Nivolumab (Drug)

Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W

Experimental

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 1.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.

干预措施: INCAGN01876 (Drug)

Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W

Experimental

干预措施: Nivolumab (Drug)

Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W

Experimental

干预措施: INCAGN01876 (Drug)

Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W

Experimental

干预措施: Nivolumab (Drug)

Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W

Experimental

Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 5.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.

干预措施: INCAGN01876 (Drug)

Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W

Experimental

干预措施: Nivolumab (Drug)

Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W

Experimental

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).

干预措施: INCAGN01876 (Drug)

Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W

Experimental

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).

干预措施: Ipilimumab (Drug)

Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W

Experimental

Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

干预措施: INCAGN01876 (Drug)

Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W

Experimental

Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

干预措施: Ipilimumab (Drug)

Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W

Experimental

Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

干预措施: INCAGN01876 (Drug)

Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W

Experimental

Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

干预措施: Ipilimumab (Drug)

Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab

Experimental

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.

干预措施: INCAGN01876 (Drug)

Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab

Experimental

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.

干预措施: Nivolumab (Drug)

Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab

Experimental

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.

干预措施: Ipilimumab (Drug)

Phase 2 Group C2 PD-1/PD-L1: INCAGN01876 300 mg + ipilimumab 1 mg/kg

Experimental

Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

干预措施: INCAGN01876 (Drug)

Phase 2 Group C2 PD-1/PD-L1: INCAGN01876 300 mg + ipilimumab 1 mg/kg

Experimental

干预措施: Ipilimumab (Drug)

Phase 2 Group F GC: INCAGN01876 300 mg + nivolumab 240 mg

Experimental

Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: INCAGN01876 (Drug)

Phase 2 Group F GC: INCAGN01876 300 mg + nivolumab 240 mg

Experimental

Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: Nivolumab (Drug)

Phase 2 Group F SCCHN INCAGN01876 300 mg + nivolumab 240 mg

Experimental

Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: INCAGN01876 (Drug)

Phase 2 Group F SCCHN INCAGN01876 300 mg + nivolumab 240 mg

Experimental

Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: Nivolumab (Drug)

Phase 2 Group F CC: INCAGN01876 300 mg + nivolumab 240 mg

Experimental

Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: INCAGN01876 (Drug)

Phase 2 Group F CC: INCAGN01876 300 mg + nivolumab 240 mg

Experimental

Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: Nivolumab (Drug)

Phase 2 Group F PD-1/PD-L1: INCAGN01876 300 mg + nivolumab 240 mg

Experimental

Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: INCAGN01876 (Drug)

Phase 2 Group F PD-1/PD-L1: INCAGN01876 300 mg + nivolumab 240 mg

Experimental

Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: Nivolumab (Drug)

Phase 2 Group F Biopsy: INCAGN01876 300 mg + nivolumab 240 mg

Experimental

Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

干预措施: INCAGN01876 (Drug)

Phase 2 Group F Biopsy: INCAGN01876 300 mg + nivolumab 240 mg

Experimental

干预措施: Nivolumab (Drug)

结局指标

主要结局

Phase 2: Objective Response Rate (ORR) Per RECIST v1.1

时间窗: up to approximately 44.7 months

ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR), determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

时间窗: up to approximately 27.4 months

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.

次要结局

Phase 1: ORR Per RECIST v1.1(up to approximately 44.7 months)
Phase 1: DOR Per mRECIST v1.1(up to approximately 44.7 months)
Phase 1: ORR Per Modified RECIST (mRECIST) v1.1(up to approximately 44.7 months)
Phase 2: ORR Per mRECIST v1.1(up to approximately 44.7 months)
Phase 1: Disease Control Rate (DCR) Per RECIST v1.1(up to approximately 44.7 months)
Phase 1: Duration of Disease Control Per mRECIST v1.1(up to approximately 44.7 months)
Phase 2: Overall Survival(up to approximately 44.7 months)
Phase 1: Duration of Response (DOR) Per RECIST v1.1(up to approximately 44.7 months)
Phase 1: Overall Survival(up to approximately 44.7 months)
Phase 2: Duration of Disease Control Per mRECIST v1.1(up to approximately 44.7 months)
Phase 1: Progression-free Survival (PFS) Per RECIST v1.1(up to approximately 44.7 months)
Phase 2: DOR Per RECIST v1.1(up to approximately 44.7 months)
Phase 2: DOR Per mRECIST v1.1(up to approximately 44.7 months)
Phase 2: Duration of Disease Control Per RECIST v1.1(up to approximately 44.7 months)
Phase 1: PFS Per mRECIST v1.1(up to approximately 44.7 months)
Phase 2: : Number of Participants With Any TEAE(up to approximately 27.4 months)
Phase 2: DCR Per RECIST v1.1(up to approximately 44.7 months)
Phase 1: DCR Per mRECIST v1.1(up to approximately 44.7 months)
Phase 2: DCR Per mRECIST v1.1(up to approximately 44.7 months)
Phase 1: Duration of Disease Control Per RECIST v1.1(up to approximately 44.7 months)
Phase 2: PFS Per RECIST v1.1(up to approximately 44.7 months)
Phase 2: PFS Per mRECIST v1.1(up to approximately 44.7 months)

研究者

发起方

Incyte Biosciences International Sàrl

申办方类型

Industry

责任方

Sponsor

研究点 (38)

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