Ignite Creation Date:
2024-05-06 @ 9:44 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03065764
Status:
UNKNOWN
Last Update Posted:
2017-08-17
First Post:
2017-01-20
Brief Title:
89Zr-labeled Pembrolizumab in Patients With Non-small-cell Lung Cancer
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
89Zirconium-labeled Pembrolizumab as Predictive Imaging Biomarker of Response and Toxicity in Pembrolizumab Treated Patients With Non-small-cell Lung Cancer - a Feasibility Study
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
After a screening phase of up to 42 days eligible subjects will undergo two whole body immuno-PET scans with a non-therapeutic tracer dose 2 mg of 89Zr-pembrolizumab one with and one without a preceding cold therapeutic dose of pembrolizumab For the first 3 patients PET scans will be obtained at 1 72 and 120 hours post tracer injection to determine the optimal scan time point and to perform biodistribution measurements and dosimetry All subsequent patients receive only 1 PET scan post-injection ie two PET scans The optimal time point is expected to be at day 5 post-injection Pembrolizumab treatment will continue every three weeks until two years of therapy have been administered disease progression or unacceptable adverse events
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None