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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Bristol-Myers Squibb
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02538666
First received: August 26, 2015
Last updated: June 26, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Lung Cancer Biological: Nivolumab Biological: Ipilimumab Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

  • 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


Estimated Enrollment: 810
Actual Study Start Date: September 30, 2015
Estimated Study Completion Date: October 22, 2019
Estimated Primary Completion Date: September 20, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02538666

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 190 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
Study First Received: August 26, 2015
Last Updated: June 26, 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
Antibodies, Monoclonal
Nivolumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 28, 2017