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Active, Not Recruiting

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 - CA209-451

Updated: 20 September, 2021   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Nivolumab and ipilimumab combination therapy
Biological: Ipilimumab Biological: Nivolumab
Experimental: Nivolumab monotherapy
Biological: Nivolumab
Placebo Comparator: Placebo
Other: Placebo

Key Eligibility 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com