Advanced or metastatic solid tumors: 1) Triple Negative Breast Cancer (TNBC) 2) Gastric Cancer (GC) 3) Pancreatic Cancer (PC) 4) Small Cell Lung Cancer (SCLC). 5) Bladder Cancer (BC) 6) Ovarian Cancer (OC)
Conditions
Brief summary
Objective response rate (ORR) in all assigned subjects as determined by the investigators. ORR is defined as the number of subjects with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of assigned subjects
Detailed description
Rate of treatment-related adverse events (AEs) leading to drug discontinuations during the first 12 weeks of treatment, Progression Free Survival (PFS), Overall Survival (OS)
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGIpilimumab
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) in all assigned subjects as determined by the investigators. ORR is defined as the number of subjects with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of assigned subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of treatment-related adverse events (AEs) leading to drug discontinuations during the first 12 weeks of treatment, Progression Free Survival (PFS), Overall Survival (OS) | — |
Countries
Germany
Outcome results
None listed