The purpose of this study is to determine whether nivolumab is an effective treatment for cancer that has advanced or has spread. Various tumor types may be eligible for enrollment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
239
Specified dose on specified days
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR). Best overall response is defined as the best response designation, as determined by investigator, recorded in the specified timeframe, according to the RECIST 1.1 criteria.
Time frame: From first dose to the date of objectively documented progression (per tumor-specific response criteria) or the date of subsequent therapy, whichever occurs first (up to approximately 24 months)
Duration of Response (DOR)
DOR is defined as the time from first confirmed response (Complete Response, CR or Partial Response, PR) to the date of the first documented tumor progression (as determined by investigator) or death due to any cause, whichever occurs first. Median DOR computed using Kaplan-Meier method
Time frame: From the time of first confirmed response to the date of the first documented progression (up to approximately 22 months)
Time to Objective Response (TTR)
TTR is defined as the time from first dosing date to the date of the first confirmed response (Complete Response, CR or Partial Response, PR), as assessed by investigator.
Time frame: From the first dosing date to the date of the first confirmed response (up to approximately 10 months)
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) or Stable Disease (SD).
Time frame: From the first dosing date to the date of the last dose (approximately 24 months)
Overall Survival Rate at 1 Year
Overall Survival (OS) is defined as the time from the first dosing date to the date of death. A participant who has not died will be censored at last known date alive. OS rate at 1 year is measured as the percent of participants still alive at 1 year after first dosing, measured from Kaplan-Meier curve of OS.
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Arizona Oncology Associates, PC
Tucson, Arizona, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, United States
St. Jude Hospital Yorba Linda
Fullerton, California, United States
LACN
Los Angeles, California, United States
UCLA Main Campus - University California Los Angeles
Los Angeles, California, United States
Torrence Health Association, DBA Torrance Memorial;Physician Network/Cancer Care Associates
Redondo Beach, California, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Cancer Center of Santa Barbara with Sansum Clinic
Santa Barbara, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
Rocky Mountain Cancer Centers - Denver Midtwon
Denver, Colorado, United States
...and 35 more locations
Time frame: From the first dosing date to 1 year later
Number of Participants Who Died
Number of participants who died for any cause
Time frame: From first dose to 100 days following last dose (up approximately 27 months)
Number of Participants Experiencing Adverse Events (AEs)
Number of participants who experienced any grade, any cause AEs
Time frame: From first dose to 30 days following the last dose (up to approximately 25 months)
Number of Participants Experiencing Serious Adverse Events (SAEs)
Number of participants who experienced any grade, any cause SAEs
Time frame: From first dose to 100 days following the last dose (up to approximately 27 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Number of participants who experienced AEs leading to discontinuation of study therapy
Time frame: From first dose to 30 days following the last dose (up to approximately 25 months)
Number of Participants Experiencing Immune-mediated Adverse Events (IMAEs)
Number of participants who experienced IMAEs. IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Time frame: From first dose to 100 days following the last dose (up to approximately 27 months)
Number of Participants Experiencing Select Adverse Events
Number of participants who experienced Select Adverse Events. Select Adverse Events categories include: gastrointestinal, hepatic, pulmonary, renal, skin, hypersensitivity/infusion reaction.
Time frame: From first dose to 30 days following the last dose (up to approximately 25 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Dose Delay or Dose Reduction
Number of participants who experienced AEs leading to dose delay or dose reduction. A dose will be considered as delayed if the delay is exceeding 3 days after the intended dose date (i.e., greater than or equal to 4 days from scheduled dosing date)
Time frame: From first dose to 30 days following the last dose (up to approximately 25 months)
Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
Number of participants who experienced the laboratory abnormalities in specific liver tests described in the individual categories. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Time frame: From first dose to 30 days following the last dose (up to approximately 25 months)
Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests
Number of participants who experienced the laboratory abnormalities in specific thyroid tests described in the individual categories. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Time frame: From first dose to 100 days following the last dose (up to approximately 27 months)