跳至主要内容
临床试验/EUCTR2018-001423-40-IT
EUCTR2018-001423-40-IT进行中(未招募)1 期

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma - 17-214-08

BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO0 个研究点目标入组 1,020 人开始时间: 2021年6月8日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
1,020

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Eastern Cooperative Oncology Group (ECOG) performance status of
  • (minors ages 12-17 only)
  • - Histologically confirmed stage III (unresectable) or stage IV melenoma
  • - Treatment-naive participants (ie, no prior systemic anticancer therapy
  • for unresectable or metastatic melanoma) with the exception of prior
  • adjuvant and/or neoadjuvant treatment for melanoma with approved
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 561
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 408

排除标准

  • - Active brain metastases or leptomeningeal metastases
  • - Uveal melanoma
  • - Participants with an active, known or suspected autoimmune disease

研究者

相似试验

进行中(未招募)
1 期
An Investigational Immunotherapy Study of NKTR-214 and Nivolumab vs Nivolumab alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
EUCTR2018-001423-40-FRBristol-Myers Squibb International Corporation1,020
进行中(未招募)
1 期
A study of NKTR-214 combined with Nivolumab vs Nivolumab alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
EUCTR2018-001423-40-Outside-EU/EEABristol-Myers Squibb International Corporation
进行中(未招募)
1 期
An Investigational Immunotherapy Study of NKTR-214 and Nivolumab vs Nivolumab alone in Participants With Previously Untreated Inoperable or Metastatic Melanomantreated unresectable or metastatic melanomaMedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864
EUCTR2018-001423-40-ESBristol-Myers Squibb International Corporation1,020
进行中(未招募)
1 期
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab alone in Participants With Previously Untreated Inoperable or Metastatic Melanomantreated unresectable or metastatic melanomaMedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864
EUCTR2018-001423-40-NLBristol-Myers Squibb International Corporation764
进行中(未招募)
1 期
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab alone in Participants With Previously Untreated Inoperable or Metastatic Melanomantreated unresectable or metastatic melanomaMedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864
EUCTR2018-001423-40-GRBristol-Myers Squibb International Corporation1,009