cholangiocarcinoma or gallbladder carcinoma
Conditions
Brief summary
ORR@6, defined as proportion of subjects with complete response (CR) or partial response (RP) according to unconfirmed RECIST v1.1 at 6 months after treatment initiation.
Detailed description
PFS, defined as time from enrolment until the date of first objectively documented progression according to RECIST v1.1, OS, defined as time from enrolment to the date of death of any cause, PFS rate at 6, 9 and 12 months (PFSR@6, PFSR@9, PFSR@12), defined as proportion of patients without progression after 6, 9 and 12 months, Assessment of safety of the treatment as determined by the incidence, nature, causality, seriousness, and severity of adverse events using NCI CTCAE 5.0
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Institut fuer Klinische Krebsforschung IKF GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR@6, defined as proportion of subjects with complete response (CR) or partial response (RP) according to unconfirmed RECIST v1.1 at 6 months after treatment initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, defined as time from enrolment until the date of first objectively documented progression according to RECIST v1.1, OS, defined as time from enrolment to the date of death of any cause, PFS rate at 6, 9 and 12 months (PFSR@6, PFSR@9, PFSR@12), defined as proportion of patients without progression after 6, 9 and 12 months, Assessment of safety of the treatment as determined by the incidence, nature, causality, seriousness, and severity of adverse events using NCI CTCAE 5.0 | — |
Countries
Germany
Outcome results
None listed