89Zr-labeled Pembrolizumab in Patients With Non-small-cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03065764|
Recruitment Status : Active, not recruiting
First Posted : February 28, 2017
Last Update Posted : August 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: 89Zr-Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 20, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
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 7 patients receive only 1 PET scan post-injection (i.e. two PET scans).
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.
Other Name: Pembrolizumab
- Treatment-related adverse events of 89Zr-pembrolizumab will be assessed by CTCAE v 4.0. [ Time Frame: up to 2 years ]Safety assessment will be measured through adverse events, changes in laboratory test results, changes in vital signs, and exposure to 89Zr-pembrolizumab. Adverse event data will be recorded and summarized according to NCI CTCAE v4.0.
- Description of 89Zr-pembrolizumab uptake in tumor lesions by measuring standardized uptake value (SUV) on the 89Zr-pembrolizumab-PET scans [ Time Frame: up to 2 years ]Description of 89Zr-pembrolizumab uptake in tumor lesions by measuring standardized uptake value (SUV) on the 89Zr-pembrolizumab-PET scans
- Visual 89Zr-pembrolizumab uptake in tumor lesions will be scored as positive or negative. [ Time Frame: up to 2 years ]Visual 89Zr-pembrolizumab uptake in tumor lesions will be scored as positive or negative.
- Characterize tumor uptake heterogeneity between patients and within and between tumor lesions of the same patient [ Time Frame: up to 2 years ]Intrapatient and interpatient 89Zr-pembrolizumab tumor uptake heterogeneity is expected and can be visualized.
- Characterize the relationship between 89Zr-pembrolizumab tumor uptake and tumor and TIL PD-1 and PD-L1 expression as well as other blood and tissue parameters [ Time Frame: up to 2 years ]Differences in 89Zr-pembrolizumab tumor uptake can be explained by (spatial) differences in tumor and TIL PD-1 and PD-L1 expression.
- Explore the relationship between 89Zr-pembrolizumab organ uptake with irAEs. The focus will be on the gut, lung, liver, thyroid and pituitary. [ Time Frame: up to 2 years ]The level of tracer uptake in target irAE tissues correlates with immune-related toxicity.
- Assess uptake of 89Zr-pembrolizumab in normal tissues by measuring standardized uptake value (SUV) to evaluate the biodistribution and dosimetry. [ Time Frame: up to 2 years ]Assess uptake of 89Zr-pembrolizumab in normal tissues by measuring standardized uptake value (SUV) to evaluate the biodistribution and dosimetry.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065764
|Amsterdam, Noord-Holland, Netherlands, 1081HV|
|Principal Investigator:||EF Smit||VUMedicalcentre|