Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-04 @ 5:04 PM
Study NCT ID:
NCT03023904
Status:
WITHDRAWN
Last Update Posted:
2018-04-25
First Post:
2017-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nivolumab in Treating Patients With Stage IV or Recurrent Lung Cancer With High Mutation Loads
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
Nivolumab in Treating Patients With Stage IV or Recurrent Lung Cancer With High Mutation Loads
Status:
WITHDRAWN
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Research cancelled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-00047 | REGISTRY | NCI, Clinical Trials Reporting Program | View |