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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 907
- Locations
- 197
- Primary Endpoint
- Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo
Intervention: Placebo (Other)
Nivolumab and ipilimumab combination therapy
Nivolumab and ipilimumab intravenous fusion
Intervention: Ipilimumab (Biological)
Nivolumab and ipilimumab combination therapy
Nivolumab and ipilimumab intravenous fusion
Intervention: Nivolumab (Biological)
Nivolumab monotherapy
Nivolumab intravenous fusion
Intervention: Nivolumab (Biological)
Outcomes
Primary Outcomes
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population
Time Frame: From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)
OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug
Secondary Outcomes
- Overall Survival (OS) of Nivolumab Versus Placebo(From randomization to the date of death or last known alive date (up to approximately 73 months))
- Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab(From randomization to the date of death or last known alive date (up to approximately 73 months))
- Progression Free Survival (PFS) Per BICR(From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months))
- Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population(From randomization to the date of death or last known alive date (up to approximately 73 months))
- Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population(From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months))