Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03110328 |
| Other study ID # |
2016-12-145 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
February 7, 2018 |
| Est. completion date |
March 24, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Samsung Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
eligible subjects will receive treatment beginning on Day 1 of each 3-week dosing cycle for
pembrolizumab. Treatment with pembrolizumab will continue until documented disease
progression, unacceptable adverse event(s),intercurrent illness that prevents further
administration of treatment, Investigator's decision to withdraw the subject, subject
withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure
requirements, subject receives 24 months of pembrolizumab, or administrative reasons
requiring cessation of treatment.
Description:
This is a single-arm, single-center, open-label trial of pembrolizumab (MK-3475) in subjects
with metastatic biliary tract cancer as second-line treatment after failing to at least one
cytotoxic chemotherapy regimen
Approximately 33 subjects will be enrollment to evaluate the efficacy and safety of
pembrolizumab.
Enrollment will begin with all subjects without regard for PD-L1 expression status.
An evaluable specimen for PD-L1 status must be available and confirmed prior to enrollment.
All study subjects will be evaluated every 6 weeks (+/- 7 days) following the date of IP drug
adminstration for the first six months and every 12 weeks (+/- 7 days) thereafter until
progression of disease is documented with radiologic imaging (computed tomography or magnetic
resonance imaging).
The primary efficacy endpoint is ORR (objective response rate) per RECIST 1.1. If a subject
has progression of disease by RECIST 1.1, it is recommended that the subject be discontinued
from the study treatment unless, in the Investigator's opinion, the subject is deriving
benefit from treatment.
Adverse events will be monitored throughout the trial and graded in severity according to the
guidelines outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version
4.0.
Except as noted above, treatment with pembrolizumab will continue until documented disease
progression, unacceptable adverse event(s), intercurrent illness that prevents further
administration of treatment, Investigator's decision to withdraw the subject, subject
withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure
requirements, completion of 24 months of pembrolizumab, or administrative reasons requiring
the cessation of treatment.
After the end of treatment, each subject will be followed for 30 days for adverse event
monitoring (serious adverse events and events of clinical interest will be collected for 90
days after the end of treatment or 30 days after the end of treatment if the subject
initiates new anticancer therapy, whichever is earlier).Subjects who discontinue treatment
for reasons other than disease progression will have post-treatment follow-up for disease
status until disease progression, initiating a non-study cancer treatment, withdrawing
consent, or becoming lost to follow-up. All subjects will be followed by telephone contact
for overall survival until death, withdrawal of consent or the end of the study, whichever
comes first.
