Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT03023904
Brief Summary:
This phase II trial studies how well nivolumab works in treating patients with stage IV lung cancer or that has come back after initial treatment who has high mutation loads. Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
SECONDARY OBJECTIVES:
I. To assess the progression-free survival (PFS). II. To assess the overall survival (OS). III. To correlate response and mutation load with PD-L1 status (5% and 1% cutoffs).
IV. To assess clinical benefit (responses and stable disease lasting \>= 6 months).
V. To assess the response rate in mutation-defined subgroups, including subjects with \>= 25 mutations/mutational burden (MB) and \>= 30 mutations/MB.
VI. To correlate the type of mutations with response.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 2 weeks for up to 2 years (104 weeks) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 35 days and then every 3 months for 2 years.
Study:
NCT03023904
Study Brief:
Protocol Section:
NCT03023904