colorectal metastatic cancer
Conditions
Brief summary
The primary endpoint for the trial is OS time, defined as the interval from enrollment to death for every cause
Detailed description
The overall response rate (ORR) according to RECIST 1.1 defined as the proportion of patients who have a partial or complete response to therapy, Progression free survival (PFS) according to RECIST 1.1 defined as the time from random assignment in the clinical trial to disease progression or death from any cause., Safety endpoints include AEs, assessed throughout the trial and evaluated using the NCI- CTCAE version 5.0 (CTCAE v 5.0), clinical laboratory assessments, vital signs, and electrocardiogram (ECG) parameters
Interventions
DRUGCETUXIMAB
DRUGAVELUMAB
Sponsors
Gruppo Oncologico Dell'Italia Meridionale
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for the trial is OS time, defined as the interval from enrollment to death for every cause | — |
Secondary
| Measure | Time frame |
|---|---|
| The overall response rate (ORR) according to RECIST 1.1 defined as the proportion of patients who have a partial or complete response to therapy, Progression free survival (PFS) according to RECIST 1.1 defined as the time from random assignment in the clinical trial to disease progression or death from any cause., Safety endpoints include AEs, assessed throughout the trial and evaluated using the NCI- CTCAE version 5.0 (CTCAE v 5.0), clinical laboratory assessments, vital signs, and electrocardiogram (ECG) parameters | — |
Countries
Italy
Outcome results
None listed