CheckMate 451: CHECKpoint pathway and nivolumab clinical Trial Evaluation 451

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223037

Enrollment

810

Registered

2015-12-08

Start date

2015-12-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

investigational material(s) Generic name etc : Nivolumab INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigationa

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS) [ Time Frame: Approximately 30 months after the first subject is randomized ] [ Designated as safety issue: No ] Progression-free survival (PFS) [ Time Frame: Approximately 6 months after the last subject is randomized ] [ Designated as safety issue: No ]	—

Secondary

Measure	Time frame
A PFS descriptive analysis will be performed to evaluate nivolumab monotherapy to nivolumab with Ipilimumab treatment regimen [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ] 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 to nivolumab with Ipilimumab treatment regimen [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ] Descriptive analyses of OS will be performed to evaluate differences between the two experimental arms	—

Measure

Time frame

A PFS descriptive analysis will be performed to evaluate nivolumab monotherapy to nivolumab with Ipilimumab treatment regimen [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ] 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 to nivolumab with Ipilimumab treatment regimen [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ] Descriptive analyses of OS will be performed to evaluate differences between the two experimental arms

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Korea, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026