The purpose of this study is to evaluate two dosing regimens of subcutaneous Nivolumab in combination with intravenous Ipilimumab and chemotherapy in participants with previously untreated metastatic or recurrent Non-Small Cell Lung Cancer (NSCLC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum
Time frame: Up to 3 weeks
Time to peak concentration (Tmax) of subcutaneous Nivolumab in serum
Time frame: Up to 3 weeks
Area under the concentration-time curve within a dosing interval (AUC(TAU)) of subcutaneous Nivolumab in serum
Time frame: Up to 3 weeks
Concentration at the end of a dosing interval (Ctau) of subcutaneous Nivolumab in serum
Time frame: Up to 3 weeks
Trough observed concentration (Ctrough) of subcutaneous Nivolumab
Time frame: At Cycle 7 Day 1 (Week 18)
Number of participants with adverse events (AEs)
Time frame: Up to approximately 2.5 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately 2.5 years
Number of participants with drug related AEs
Time frame: Up to approximately 2.5 years
Number of participants with Immune Mediated Adverse Events (IMAEs)
Time frame: Up to approximately 2.5 years
Number of participants with AEs leading to discontinuation
Time frame: Up to approximately 2.5 years
Number of deaths
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0032
Anchorage, Alaska, United States
Local Institution - 0062
Los Angeles, California, United States
Local Institution - 0063
Boise, Idaho, United States
Local Institution - 0052
Boise, Idaho, United States
Local Institution - 0064
Post Falls, Idaho, United States
Local Institution - 0047
Cleveland, Ohio, United States
Local Institution - 0033
Cleveland, Ohio, United States
Local Institution - 0051
Allentown, Pennsylvania, United States
Local Institution - 0041
Brasília, Federal District, Brazil
Local Institution - 0043
Belo Horizonte, Minas Gerais, Brazil
...and 28 more locations
Time frame: Up to approximately 2.5 years
Number of participants with anti-nivolumab antibodies
Time frame: Up to approximately 2.5 years
Number of participants with anti-ipilimumab antibodies
Time frame: Up to approximately 2.5 years
Number of participants with neutralizing antibodies
Time frame: Up to approximately 2.5 years
Cmax of intravenous Ipilimumab in serum
Time frame: Up to 6 weeks
Tmax of intravenous Ipilimumab in serum
Time frame: Up to 6 weeks
AUC(TAU) of intravenous Ipilimumab in serum
Time frame: Up to 6 weeks
Ctau of intravenous Ipilimumab in serum
Time frame: Up to 6 weeks