Metastatic Microsatellite Stable Colorectal Cancer
Conditions
Brief summary
PFS, defined as the time from the date of randomization to the date of the first documented progression as determined by BICR (Blinded Independent Central Review) per RECIST v1.1 or death due to any cause.
Detailed description
OS, defined as the time from the date of randomization to the date of death due to any cause., Objective response, defined as CR or PR as determined by BICR (Blinded Independent Central Review) per RECIST v1.1., DOR, defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by BICR per RECIST v1.1 or death due to any cause, whichever occurs first., TEAEs per CTCAE v6.0 and TEAEs leading to dose interruption or study drug discontinuation.
Interventions
DRUGINCA33890
DRUGPlacebo contains the same formulation buffer
DRUG10 mM acetate
DRUG9% (w/v) sucrose and 0.02% (w/v) polysorbate 80
DRUGat pH 5.5
DRUGwithout the active pharmaceutical ingredient.
DRUGCALCIUM FOLINATE
DRUGBEVACIZUMAB
DRUGOXALIPLATIN
DRUGFLUOROURACIL
Sponsors
Incyte Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from the date of randomization to the date of the first documented progression as determined by BICR (Blinded Independent Central Review) per RECIST v1.1 or death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, defined as the time from the date of randomization to the date of death due to any cause., Objective response, defined as CR or PR as determined by BICR (Blinded Independent Central Review) per RECIST v1.1., DOR, defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by BICR per RECIST v1.1 or death due to any cause, whichever occurs first., TEAEs per CTCAE v6.0 and TEAEs leading to dose interruption or study drug discontinuation. | — |
Outcome results
None listed