lung cancer; kidney cancer; melanoma; liver cancer; colorectal cancer; bladder cancer
Conditions
Brief summary
Serum nivolumab Parts A, B, D, and E: -Cmax (Maximal concentration) -Tmax (Time to maximal concentration) -AUC(TAU)(Area under the concentration-time curve over the dosing interval) -Ctau (observed serum nivolumab concentration at the end of the dosing interval), Serum nivolumab Part C: -Ctrough (trough observed serum nivolumab concentration)
Detailed description
- Incidences of AEs, TRAEs, SAEs, TRSAEs, AEs/TRAEs leading to discontinuation, deaths, and laboratory abnormalities, - Incidence of AEs in the MedDRA Anaphylactic Reaction broad scope SMQ occurring within 2 days after study drug administration, - Incidence of events within the hypersensitivity/infusion reaction select AE category occurring within 2 days after any study drug administration., - Incidence of anti-nivolumab antibodies and neutralizing antibodies, if applicable
Interventions
DRUGMDX1106 ONO-4538
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum nivolumab Parts A, B, D, and E: -Cmax (Maximal concentration) -Tmax (Time to maximal concentration) -AUC(TAU)(Area under the concentration-time curve over the dosing interval) -Ctau (observed serum nivolumab concentration at the end of the dosing interval), Serum nivolumab Part C: -Ctrough (trough observed serum nivolumab concentration) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidences of AEs, TRAEs, SAEs, TRSAEs, AEs/TRAEs leading to discontinuation, deaths, and laboratory abnormalities, - Incidence of AEs in the MedDRA Anaphylactic Reaction broad scope SMQ occurring within 2 days after study drug administration, - Incidence of events within the hypersensitivity/infusion reaction select AE category occurring within 2 days after any study drug administration., - Incidence of anti-nivolumab antibodies and neutralizing antibodies, if applicable | — |
Countries
France, Italy, Netherlands, Poland, Spain
Outcome results
None listed