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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 : December 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 and progression free 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: Nivolumab Biological: Ipilimumab Other: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : September 30, 2015
Estimated Primary Completion Date : September 20, 2018
Estimated Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nivolumab monotherapy
Nivolumab intravenous fusion
Biological: Nivolumab
Other Name: Opdivo
Experimental: Nivolumab and ipilimumab combination therapy
Nivolumab and ipilimumab intravenous fusion
Biological: Nivolumab
Other Name: Opdivo
Biological: Ipilimumab
Other Name: Yervoy
Placebo Comparator: Placebo
Placebo
Other: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 30 months after the first subject is randomized ]
  2. Progression-free survival (PFS) [ Time Frame: Approximately 6 months after the last subject is randomized ]

Secondary Outcome Measures :
  1. A PFS descriptive analysis will be performed to evaluate nivolumab monotherapy versus 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

  2. An OS descriptive analysis will be performed to evaluate nivolumab monotherapy versus 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538666


  Show 192 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02538666     History of Changes
Other Study ID Numbers: CA209-451
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs