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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065764
|Amsterdam, Noord-Holland, Netherlands, 1081HV|
|Principal Investigator:||EF Smit||VUMedicalcentre|