The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Specified dose on specified days
Specified dose on specified days
TACE (Trans-arterial ChemoEmbolization)
Number of Participants With Adverse Events
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Serious Adverse Events (SAEs)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose that results in death, Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) or requires inpatient hospitalization or causes prolongation of existing hospitalization, or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event.
Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants Who Died
Number of participants who died due to any cause are summarized.
Time frame: From first dose and 100 days after last dose of study therapy (up to approximately 27 months)
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). Highest grade measured for hemoglobin and albumin was Grade 3.
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Local Institution - 0189
Coronado, California, United States
Local Institution
Washington D.C., District of Columbia, United States
Local Institution - 0005
Louisville, Kentucky, United States
Local Institution - 0059
Louisville, Kentucky, United States
Local Institution - 0109
Dallas, Texas, United States
Local Institution
Wollongong, New South Wales, Australia
Local Institution - 0037
Birtinya, Queensland, Australia
Local Institution - 0010
Adelaide, South Australia, Australia
Local Institution - 0001
Melbourne, Victoria, Australia
Local Institution - 0139
Murdoch, Western Australia, Australia
...and 97 more locations
Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Blood samples were collected for specific thyroid test.
Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
Blood samples were collected for specific liver tests.
Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)