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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT02538666
• Date of registration: 26/08/2015
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: 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
• Scientific 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)
• Date of first enrolment: October 13, 2015
• Target sample size: 907
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02538666
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Bristol Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lung Cancer

Intervention(s)

Biological: Nivolumab

Biological: Ipilimumab

Other: Placebo

Primary Outcome(s)

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)]

Secondary Outcome(s)

Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population [Time Frame: 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 [Time Frame: 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) of Nivolumab Versus Placebo [Time Frame: 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 [Time Frame: From randomization to the date of death or last known alive date (up to approximately 73 months)]

Progression Free Survival (PFS) Per BICR [Time Frame: From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)]

Secondary ID(s)

2015-002441-61

CA209-451

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ono Pharmaceutical Co. Ltd

Results

• Results available: Yes
• Date Posted: 22/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02538666