Non-small cell lung cancer (NSCLC)
Conditions
Brief summary
Measuring various PK parameters of nivolumab SC in the blood during the first treatment cycle., Measuring the amount of nivolumab SC left in the body just before the next dose is given on the first day of the seventh treatment cycle.
Detailed description
Recording the incidence of side effects (adverse events or AEs), serious adverse events (SAEs), drug-related AEs, immune-mediated AEs (IMAEs), specific AEs, AEs leading to discontinuation, and deaths until 100 days post end of treatment., Measuring the incidence of antibodies against nivolumab SC and ipilimumab IV, including neutralizing antibodies if applicable, until 100 days post end of treatment., Evaluating the PK parameters of ipilimumab IV in the blood when given with nivolumab SC and chemotherapy during the first treatment cycle.
Interventions
Sponsors
Bristol-Myers Squibb Services Unlimited Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measuring various PK parameters of nivolumab SC in the blood during the first treatment cycle., Measuring the amount of nivolumab SC left in the body just before the next dose is given on the first day of the seventh treatment cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recording the incidence of side effects (adverse events or AEs), serious adverse events (SAEs), drug-related AEs, immune-mediated AEs (IMAEs), specific AEs, AEs leading to discontinuation, and deaths until 100 days post end of treatment., Measuring the incidence of antibodies against nivolumab SC and ipilimumab IV, including neutralizing antibodies if applicable, until 100 days post end of treatment., Evaluating the PK parameters of ipilimumab IV in the blood when given with nivolumab SC and chemotherapy during the first treatment cycle. | — |
Countries
France, Greece, Italy, Poland, Romania
Outcome results
None listed