Advanced/metastatic hepatocellular carcinoma (HCC)
Conditions
Brief summary
Part 1: Will be assessed by analyzing the rate of dose-limiting toxicities (unwanted side effects) among patients treated at various dose levels; once safety is confirmed, Part 2 will begin., Part 2: Efficacy will be evaluated by comparing the objective response rate (proportion of participants who respond to treatment) of each treatment, in participants with metastatic disease as well as in participants whose disease is limited to their liver.
Detailed description
Additional efficacy endpoints will be tested in both groups of participants, including evaluating progression-free survival (time from start of treatment until worsening of disease)., Safety will be evaluated in both groups of participants, specifically reviewing adverse events (unwanted side effects), serious adverse events, and immune-mediated adverse events (unwanted side-effects caused by an overactive immune system) from first dose to 30 or 135 days after the last dose.
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUG0.9% Sodium Chloride Injection
DRUGAvastin 25 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 |
|---|---|
| Part 1: Will be assessed by analyzing the rate of dose-limiting toxicities (unwanted side effects) among patients treated at various dose levels; once safety is confirmed, Part 2 will begin., Part 2: Efficacy will be evaluated by comparing the objective response rate (proportion of participants who respond to treatment) of each treatment, in participants with metastatic disease as well as in participants whose disease is limited to their liver. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional efficacy endpoints will be tested in both groups of participants, including evaluating progression-free survival (time from start of treatment until worsening of disease)., Safety will be evaluated in both groups of participants, specifically reviewing adverse events (unwanted side effects), serious adverse events, and immune-mediated adverse events (unwanted side-effects caused by an overactive immune system) from first dose to 30 or 135 days after the last dose. | — |
Countries
France, Germany, Italy, Poland, Spain
Outcome results
None listed