The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)
ORR is defined as the percentage of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method.
Time frame: Day 1 of treatment up to approximately 14 months
Duration of Response (DOR) as Assessed by Independent Radiology Review Committee (IRC)
DOR is defined as the time from first confirmed response (CR or PR) per IRC assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method.
Time frame: From the first treatment to the date of the first documented tumor progression or death. Approximately up to 14 months
Objective Response Rate (ORR) as Assessed by Investigator
ORR is defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment. The investigator-assessed ORR is summarized by a binomial response rate and its corresponding two-sided 95% exact CIs using Clopper-Pearson method.
Time frame: Day 1 of treatment to approximately 101 months
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University Of California Davis Medical Center
Sacramento, California, United States
Va San Diego Healthcare System
San Diego, California, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Winship Cancer Institute.
Atlanta, Georgia, United States
Local Institution
Metairie, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Providence Cancer Institute
Southfield, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Beth Israel Comprehensive Cancer Center
New York, New York, United States
...and 23 more locations
Duration of Response (DOR) as Assessed by Investigator
DOR is defined as the time from first confirmed response (CR or PR) per investigator assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method.
Time frame: From the first treatment to the date of the first documented tumor progression or death. Approximately up to 101 months