Ignite Creation Date:
2024-05-06 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03111732
Status:
COMPLETED
Last Update Posted:
2021-12-03
First Post:
2017-04-12
Brief Title:
Pembrolizumab a Monoclonal Antibody Against PD-1 in Combination With Capecitabine and Oxaliplatin CAPOX in People With Advanced Biliary Tract Carcinoma BTC
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase 2 Study of Pembrolizumab a Monoclonal Antibody Against PD-1 in Combination With Capecitabine and Oxaliplatin CAPOX in Subjects With Advanced Biliary Tract Carcinoma BTC
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Biliary tract cancers are rare but they are serious Researchers want to see if a certain drug helps the immune system fight cancer cells The drug is called pembrolizumab It may work even better with two chemotherapy drugs that are widely used to treat gastrointestinal cancers
Objective
To study if pembrolizumab given with capecitabine and oxaliplatin CAPOX increases the time it takes for a persons biliary tract cancer to get worse
Eligibility
People age 18 and older with previously treated biliary tract cancer that has spread to other parts of the body
Design
Participants will be screened with tests as part of their regular cancer care
Each study cycle is 3 weeks
For 6 cycles participants will
Get pembrolizumab and oxaliplatin on day 1 of each cycle They will be given in an intravenous IV catheter
Take capecitabine by mouth for 2 weeks then have 1 week without it
Participants will complete a patient diary
Starting with cycle 7 participants will get only pembrolizumab They will get it once every 3 weeks
On day 1 of every cycle participants will have
Physical exam
Review of symptoms and how well they do normal activities
Blood tests
Every 9 weeks they will have a scan
Participants may have tumor samples taken
Participants will have a final visit about 1 month after they stop the study drug After that they will be contacted by phone or email yearly
Biliary tract cancers are rare but they are serious Researchers want to see if a certain drug helps the immune system fight cancer cells The drug is called pembrolizumab It may work even better with two chemotherapy drugs that are widely used to treat gastrointestinal cancers
Objective
To study if pembrolizumab given with capecitabine and oxaliplatin CAPOX increases the time it takes for a persons biliary tract cancer to get worse
Eligibility
People age 18 and older with previously treated biliary tract cancer that has spread to other parts of the body
Design
Participants will be screened with tests as part of their regular cancer care
Each study cycle is 3 weeks
For 6 cycles participants will
Get pembrolizumab and oxaliplatin on day 1 of each cycle They will be given in an intravenous IV catheter
Take capecitabine by mouth for 2 weeks then have 1 week without it
Participants will complete a patient diary
Starting with cycle 7 participants will get only pembrolizumab They will get it once every 3 weeks
On day 1 of every cycle participants will have
Physical exam
Review of symptoms and how well they do normal activities
Blood tests
Every 9 weeks they will have a scan
Participants may have tumor samples taken
Participants will have a final visit about 1 month after they stop the study drug After that they will be contacted by phone or email yearly
Detailed Description:
Background
The most compelling argument in favor of testing immune-based strategies and anti-Programmed cell death protein 1 PD1 therapy in particular in biliary tract cancers BTC is that chronic inflammation appears to be the most common etiologic factor in the development of biliary tract cancer
Single-agent activity has been shown for PD1-directed therapy in BTC Given the potential for oxaliplatin-induced immunogenic cell death we would like to evaluate the combination of capecitabine and oxaliplatin CAPOX chemotherapy with pembrolizumab
Objective
To determine the 5-month progression free survival PFS of Pembrolizumab in combination with CAPOX in patients with advanced biliary tract carcinoma
Eligibility
Histologically confirmed diagnosis biliary tract carcinoma OR histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which together with the pathology are highly suggestive of a diagnosis of biliary tract carcinoma
Patients must have at least one prior chemotherapeutic regimen
Patients must have disease that is not amenable to potentially curative resection
No prior treatment with oxaliplatin
Design
The proposed study is a phase II study of Pembrolizumab in combination with CAPOX in patients with advanced biliary tract carcinoma
The most compelling argument in favor of testing immune-based strategies and anti-Programmed cell death protein 1 PD1 therapy in particular in biliary tract cancers BTC is that chronic inflammation appears to be the most common etiologic factor in the development of biliary tract cancer
Single-agent activity has been shown for PD1-directed therapy in BTC Given the potential for oxaliplatin-induced immunogenic cell death we would like to evaluate the combination of capecitabine and oxaliplatin CAPOX chemotherapy with pembrolizumab
Objective
To determine the 5-month progression free survival PFS of Pembrolizumab in combination with CAPOX in patients with advanced biliary tract carcinoma
Eligibility
Histologically confirmed diagnosis biliary tract carcinoma OR histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which together with the pathology are highly suggestive of a diagnosis of biliary tract carcinoma
Patients must have at least one prior chemotherapeutic regimen
Patients must have disease that is not amenable to potentially curative resection
No prior treatment with oxaliplatin
Design
The proposed study is a phase II study of Pembrolizumab in combination with CAPOX in patients with advanced biliary tract carcinoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17-C-0082 | None | None | None |