Investigators hypothesize that following first-line platinum based chemotherapy, rucaparib in combination with nivolumab, will improve progression-free survival and overall survival in BTC patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Rogel Cancer Center
Ann Arbor, Michigan, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Proportion of Patients Alive and Without Radiological or Clinical Progression at 4 Months
Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions (with a minimum absolute increase of 5 mm), taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. A clinical decision of progression by the site investigator will be based on the subject's overall clinical condition, including performance status, clinical symptoms, and laboratory data.
Time frame: 4 months
The Proportion of Patients That Respond to Treatment
The proportion of patients that display a partial response (PR) or complete response (CR) to treatment. Partial response 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. 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: up 2 years after starting treatment, average of 4 months
Progression Free Survival (PFS) Time as Measured From Treatment Start
Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions (with a minimum absolute increase of 5 mm), taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Time frame: Up to 2 years
Progression Free Survival (PFS) Time as Measured From Start of 1st Line Platinum Therapy
Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions (with a minimum absolute increase of 5 mm), taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
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Time frame: Up to two years post treatment discontinuation
Overall Survival (OS) Time as Measured From Treatment Start
Time frame: Up to two years post treatment discontinuation
Overall Survival (OS) Time as Measured From Start of 1st Line Platinum Therapy
Time frame: Up to two years post treatment discontinuation