Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT03111732
Status:
COMPLETED
Last Update Posted:
2021-12-03
First Post:
2017-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
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:
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 person's 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 person's 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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 17-C-0082 | None | None | View |