The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
533
Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events
Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events
Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Median Time to Onset (Grades 3-4) of Select Adverse Events
Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Time to Resolution of an Adverse Event (AE)
Resolution of an adverse event (AE) is defined as a participant experiencing complete resolution or improvement to the baseline of any grade AE including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
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Local Institution
Garran, Australian Capital Territory, Australia
Local Institution
Camperdown, New South Wales, Australia
Local Institution
Coffs Harbour, New South Wales, Australia
Local Institution
Gateshead, New South Wales, Australia
Local Institution
North Sydney, New South Wales, Australia
Local Institution
Tiwi, Northern Territory, Australia
Local Institution
Brisbane, Queensland, Australia
Local Institution
Cairns, Queensland, Australia
Local Institution
Greenslopes, Queensland, Australia
Local Institution
Southport, Queensland, Australia
...and 101 more locations
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Overall Survival (OS)
Overall survival is defined from the time of first dosing date to the date of death. A participant who has not died will be censored at the last known date alive
Time frame: Up to approximately 37 months
Incidence of Participants With Adverse Events
The assessment of safety is measured by the incidence of participants who experienced any grade of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), and deaths
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With Select Adverse Events
The assessment of safety is measured by the incidence of participants who experienced any grade of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With Laboratory Abnormalities - Liver
Safety assessment is measured by the incidence of participants who experienced a liver laboratory abnormality in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Upper Limit of Normal (ULN)
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Incidence of Participants With Laboratory Abnormalities - Thyroid
Safety assessment is measured by the incidence of participants who experienced a thyroid laboratory abnormality in Free T3 (FT3), Free T4 (FT4), Lower Limit of Normal (LLN)
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated participants
Time frame: Up to approximately 37 months
Progression Free Survival (PFS)
Progression free survival per investigator assessment is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.
Time frame: Up to approximately 37 months