CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 907 enrolled
Drug / intervention
Nivolumab +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02538666
NCT02538666Phase 3Completed
CompareCT.gov

A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)

Bristol-Myers Squibb·interventional·Posted Sep 2, 2015·Updated Jan 5, 2023

In Brief

A Phase 3 clinical trial evaluating Nivolumab, Ipilimumab, and 1 other intervention for Lung Cancer. Completed, enrolled 907 participants across 197 sites in 32 countries.

Detailed Summary

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Peru, Poland, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
CollaboratorsOno Pharmaceutical Co., Ltd.

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2, 2015
Enrollment StartOct 13, 2015
Primary CompletionOct 1, 2018
Study CompletionNov 11, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 10.8 years ago

Interventions

Nivolumabbiological

Ipilimumabbiological

Placeboother