临床试验/NCT04623775

NCT04623775已完成2 期

A Phase 2 Randomized Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Bristol-Myers Squibb246 个研究点分布在 5 个国家目标入组 468 人开始时间: 2021年2月17日最近更新: 2026年6月18日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 468
试验地点: 246
主要终点: TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 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相关资讯

研究概览

简要总结

The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

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

•Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease.
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization.
•Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria.
•No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease.

排除标准

•Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy.
•Untreated CNS metastases.
•Leptomeningeal metastases (carcinomatous meningitis).
•Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease).
•Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
•Other protocol-defined Inclusion/Exclusion criteria apply.

研究组 & 干预措施

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Experimental

干预措施: Nivolumab (Biological)

Part 2: Arm D (Nivolumab + PDCT)

Active Comparator

干预措施: Pemetrexed (Drug)

Part 2: Arm D (Nivolumab + PDCT)

Active Comparator

干预措施: Paclitaxel (Drug)

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Experimental

干预措施: Relatlimab (Biological)

Part 2: Arm D (Nivolumab + PDCT)

Active Comparator

干预措施: Cisplatin (Drug)

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Experimental

干预措施: Nivolumab (Biological)

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Experimental

干预措施: Relatlimab (Biological)

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Experimental

干预措施: Carboplatin (Drug)

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Experimental

干预措施: Cisplatin (Drug)

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Experimental

干预措施: Paclitaxel (Drug)

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Experimental

干预措施: Nab-Paclitaxel (Drug)

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Experimental

干预措施: Pemetrexed (Drug)

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Experimental

干预措施: Nivolumab (Biological)

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Experimental

干预措施: Carboplatin (Drug)

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Experimental

干预措施: Cisplatin (Drug)

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Experimental

干预措施: Nab-Paclitaxel (Drug)

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Experimental

干预措施: Relatlimab (Biological)

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Experimental

干预措施: Carboplatin (Drug)

Part 2: Arm D (Nivolumab + PDCT)

Active Comparator

干预措施: Nivolumab (Biological)

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Experimental

干预措施: Paclitaxel (Drug)

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Experimental

干预措施: Pemetrexed (Drug)

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Experimental

干预措施: Pemetrexed (Drug)

Part 2: Arm D (Nivolumab + PDCT)

Active Comparator

干预措施: Carboplatin (Drug)

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Experimental

干预措施: Cisplatin (Drug)

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Experimental

干预措施: Paclitaxel (Drug)

结局指标

主要结局

TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1

时间窗: from first dose to 12 weeks after first dose

Percentage of participants with treatment related adverse events (TRAEs) leading to discontinuation within 12 weeks of first dose. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0.

ORR Per RECISTS v1.1 by BICR in Part 2

时间窗: Approximately 14.8 Months

Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.

次要结局

TRAEs Leading to Discontinuation in Part 1(From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months))
Number of Participants With a Treatment Related AEs in Part 1(From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months))
Number of Participants With Treatment Releted SAEs in Part 1(From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months))
Number of Participants With Treatment Releted Select AEs in Part 1(From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months))
ORR by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2(Approximately 14.8 Months)
DoR Per RECISTS v1.1 by BICR in Part 2(Approximately up to 13.7 months)
Number of Participants With a AE in Part 2(From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months))
Number of Participants With a Treatment Related AEs in Part 2(From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months))
PFS Per RECISTS v1.1 by BICR in Part 2(Ongoing)
PFS by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2(Ongoing)
PFS by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2(Ongoing)
PFS by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2(Ongoing)
Number of Participants With Treatment Releted Select AEs in Part 2(Ongoing)
Number of Participants With a Treatment Related SAEs in Part 2(From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months))
Number of Participants With Endocrine Immune-mediated Adverse Events in Part 2(From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months))
ORR by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2(On Going)
ORR by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2(Ongoing)

研究者

发起方

Bristol-Myers Squibb

申办方类型

Industry

责任方

Sponsor

研究点 (246)

Loading locations...

相似试验

进行中（未招募）

2 期

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced MelanomaMelanoma

NCT03470922Bristol-Myers Squibb714

进行中（未招募）

2 期

Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic MelanomaMetastatic Melanoma

NCT03646617Abramson Cancer Center at Penn Medicine62

终止

2 期

Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory MyelomaRelapsed Multiple MyelomaRefractory Multiple Myeloma

NCT04119336Andrew Yee, MD2

已完成

2 期

A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese ParticipantsMesothelioma, Malignant

NCT05136677Bristol-Myers Squibb102

终止

3 期

A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal CancerColorectal Neoplasms

NCT05328908Bristol-Myers Squibb769