This is a phase 2, single arm, two-stage study of abraxane with an anti-PD1/PDL1 (pembrolizumab) in cisplatin-ineligible patients with advanced urothelial cancer. Each cycle last 21-days. All subjects will receive pembrolizumab via IV on day 1, and abraxane via IV on Day 1 and Day 8 of each cycle. Subjects may continue to receive the study regimen until they experience disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
200mg IV D1
100mg/m\^2 D1 and D8
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Percentage of Patients That Respond to Treatment
The Overall Response Rate (ORR) will be the percentage of patients that achieve either complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.
Time frame: 24 months post treatment, an average of 7.5 months
Duration of Response
The duration of response (DOR) is measured from the time that response (PR or CR) criteria are met until the first date that recurrent or progressive disease is objectively documented. CR is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.
Time frame: 24 months post treatment
Progression Free Survival Time
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Time frame: 24 months post treatment
Median Number of Patients Alive at 12 and 24 Months
Overall survival will be documented as the median number of patients alive at 12 and 24 months.
Time frame: 12 and 24 months post treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Median Duration of Therapy
Time frame: from the start of therapy, up to 24 months
Percentage of Patients That Completely Respond to Treatment
The percentage of patients that achieve complete response to treatment. Complete response is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.
Time frame: 24 months post treatment, an average of 7.5 months