Advanced, metastatic, solid malignancy
Conditions
Brief summary
Incidence of dose-limiting toxicities, adverse events (AEs), serious AEs (SAEs, adverse events leading to discontinuation, and deaths based on NCI-CTCAE v5.0
Detailed description
Summary of pharmacokinetic parameters of BMS-986449 and its metabolite in plasma (e.g. maximum observed concentration within a dosing interval, time of maximum observed concentration and area under the concentration–time curve within a dosing interval from concentration–time data during BMS986449 monotherapy and in combination with nivolumab.
Interventions
DRUGHELIOS Degrader
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Bristol-Myers Squibb Services Unlimited Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicities, adverse events (AEs), serious AEs (SAEs, adverse events leading to discontinuation, and deaths based on NCI-CTCAE v5.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Summary of pharmacokinetic parameters of BMS-986449 and its metabolite in plasma (e.g. maximum observed concentration within a dosing interval, time of maximum observed concentration and area under the concentration–time curve within a dosing interval from concentration–time data during BMS986449 monotherapy and in combination with nivolumab. | — |
Countries
Belgium, France, Italy, Netherlands, Spain
Outcome results
None listed