Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy (CheckMate 451)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02538666
Recruitment Status : Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE August 26, 2015
First Posted Date  ICMJE September 2, 2015
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE September 30, 2015
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
Overall Survival (OS) [ Time Frame: Approximately 37 months after the first subject is randomized ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
  • Overall Survival (OS) [ Time Frame: Approximately 30 months after the first subject is randomized ]
  • Progression-free survival (PFS) [ Time Frame: Approximately 6 months after the last subject is randomized ]
Change History Complete list of historical versions of study NCT02538666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • Progression Free Survival (PFS) [ Time Frame: Approximately 37 months ]
    Blinded Independent Central Review (BICR) assessed
  • An OS descriptive analysis will be performed to evaluate nivolumab monotherapy versus nivolumab with Ipilimumab treatment regimen [ Time Frame: Approximately 37 months ]
    Descriptive analyses of OS will be performed to evaluate differences between the two experimental arms
  • A PFS descriptive analysis will be performed to evaluate nivolumab monotherapy versus nivolumab with Ipilimumab treatment regimen [ Time Frame: Approximately 37 months ]
    Descriptive analyses of PFS will be performed to evaluate differences between the two experimental arms
  • Tumor mutation burden (TMB) [ Time Frame: Approximately 37 months ]
    measured using FoundationOne CDx™ (F1CDx) assay
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
  • A PFS descriptive analysis will be performed to evaluate nivolumab monotherapy to nivolumab with Ipilimumab treatment regimen [ Time Frame: Approximately 30 months ]
    Descriptive analyses of PFS will be performed to evaluate differences between the two experimental arms
  • An OS descriptive analysis will be performed to evaluate nivolumab monotherapy to nivolumab with Ipilimumab treatment regimen [ Time Frame: Approximately 30 months ]
    Descriptive analyses of OS will be performed to evaluate differences between the two experimental arms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy
Official Title  ICMJE 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)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Other Name: Opdivo
  • Biological: Ipilimumab
    Other Name: Yervoy
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Nivolumab monotherapy
    Nivolumab intravenous fusion
    Intervention: Biological: Nivolumab
  • Experimental: Nivolumab and ipilimumab combination therapy
    Nivolumab and ipilimumab intravenous fusion
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 12, 2018)
1327
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2015)
810
Estimated Study Completion Date  ICMJE November 20, 2019
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects with histologically or cytologically confirmed extensive stage disease SCLC
  • Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Subjects with symptomatic Central Nervous System (CNS) metastases
  • Subjects receiving consolidative chest radiation
  • Subjects with active, known, or suspected autoimmune disease are excluded
  • All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Colombia,   Finland,   France,   Germany,   Greece,   Hong Kong,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Peru,   Poland,   Romania,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02538666
Other Study ID Numbers  ICMJE CA209-451
2015-002441-61 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP