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
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.
Checked against the public recordLast updated Jan 5, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Biological: Nivolumab; Biological: Ipilimumab; Other: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 Other protocol-defined inclusion/exclusion criteria apply
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Local Institution - 0003Sacramento, California
- Local Institution - 0202New Haven, Connecticut
- Local Institution - 0127Fort Myers, Florida
- Local Institution - 0007Jacksonville, Florida
- Local Institution - 0128St. Petersburg, Florida
- Local Institution - 0010Atlanta, Georgia
- Local Institution - 0013Indianapolis, Indiana
- Local Institution - 0061Fairway, Kansas
- Local Institution - 0012Wichita, Kansas
- Local Institution - 0032Lexington, Kentucky
- Local Institution - 0051Baltimore, Maryland
- Local Institution - 0107Boston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 5, 2023. Always confirm current availability with the study team.