MK-3475 in Melanoma and NSCLC Patients With Brain Metastases
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|ClinicalTrials.gov Identifier: NCT02085070|
Recruitment Status : Completed
First Posted : March 12, 2014
Results First Posted : March 24, 2021
Last Update Posted : March 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Non-Small Cell Lung Cancer Brain Metastases||Drug: MK-3475||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of MK-3475 in Patients With Metastatic Melanoma and Non-Small Cell Lung Cancer With Untreated Brain Metastases|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||February 27, 2020|
|Actual Study Completion Date :||February 27, 2020|
Experimental: Melanoma patients
After establishing eligibility criteria, for patients with melanoma the investigator will determine at least one lesion that requires local therapy (surgical resection or LITT) based on size, location, and/or risk of hemorrhage; this will be considered the "surgical lesion". All other eligible brain lesions will be considered "clinically evaluable lesions" and will be followed by modified RECIST (mRECIST) criteria to determine best response.
Non-small cell lung cancer patients
NSCLC patients are not required to have a "surgical lesion" but must have at least one "clinically evaluable lesion" in the central nervous system. Patients on NSCLC are required to have formalin-fixed, paraffin-embedded tumor tissue available for biomarker analysis.
- Overall Response in the Brain by mRECIST [ Time Frame: 8 weeks ]
RECIST criteria v1.1 was modified to account for differences in measuring the response of clinically evaluable brain lesions as opposed to systemic lesions (modified RECIST, or mRECIST). Size was considered the tumor's largest diameter. Measurements from multiple lesions were summed to calculate the sum of the diameters (SD). The SD calculated on a baseline scan performed within 28 days of study drug initiation was used as a reference to determine the objective response of the clinically evaluable lesions.
mRECIST differ from RECIST v1.0 in allowing lesions measuring 5mm or less for response evaluation, provided that the MRI slice thickness was no more than 2.5mm. Seeing that the primary trial endpoint was brain metastasis response, up to 5 lesions were used for evaluation.
Complete response (CR) constitutes complete disappearance of all target lesions, partial response (PR) constitutes >= 30% decrease in the sum of the sum of the largest diameter of target
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): NCT02085070
|United States, Connecticut|
|Smilow Cancer Center at Yale New Haven Hospital|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Harriet Kluger, MD||Yale University|