Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Trial acronym
CheckMate 451
Clinical summary
Summary
The purpose of this study is to show that maintenance therapy with nivolumab, or nivolumab plus ipilimumab followed by nivolumab alone, will prolong Overall Survival and Progression Free Survival compared with placebo in subjects with extensive stage disease small cell lung cancer who have completed first line chemotherapy.
Conditions
This trial is treating people with Small Cell Lung Cancer (SCLC)
Eligibility
Inclusion
- 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
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Bristol-Myers Squibb (BMS)
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
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