Squamous Carcinoma of the Anal Canal
Conditions
Brief summary
PFS, defined as the time from the date of randomization until disease progression according to RECIST v1.1 by BICR or death due to any cause.
Detailed description
OS, defined as the time from the date of randomization until death due to any cause., ORR, defined as the percentage of participants having a CR or PR, according to RECIST v1.1 as determined by BICR., DOR, defined as the time from the first documented response (CR or PR) according to RECIST v1.1 until disease progression as determined by BICR or death due to any cause., DCR, defined as the number of participants maintaining either an ORR or stable disease according to RECIST v1.1 as determined by BICR., Number of participants experiencing AEs and number of participants discontinuing study drug due to AEs.
Interventions
DRUGsolution pour perfusion
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 until disease progression according to RECIST v1.1 by BICR or death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, defined as the time from the date of randomization until death due to any cause., ORR, defined as the percentage of participants having a CR or PR, according to RECIST v1.1 as determined by BICR., DOR, defined as the time from the first documented response (CR or PR) according to RECIST v1.1 until disease progression as determined by BICR or death due to any cause., DCR, defined as the number of participants maintaining either an ORR or stable disease according to RECIST v1.1 as determined by BICR., Number of participants experiencing AEs and number of participants discontinuing study drug due to AEs. | — |
Countries
Belgium, Denmark, France, Germany, Italy, Norway, Spain, Sweden
Outcome results
None listed