Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC)
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|ClinicalTrials.gov Identifier: NCT03111732|
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : April 22, 2019
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.
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.
People age 18 and older with previously treated biliary tract cancer that has spread to other parts of the body
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:
Review of symptoms and how well they do normal activities
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.
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Neoplasms Cholangiocarcinoma Bile Duct Cancer Liver Cancer Gallbladder Cancer||Biological: Pembrolizumab (MK-3475) Drug: Oxaliplatin Drug: Capecitabine||Phase 2|
- The most compelling argument in favor of testing immune-based strategies (and anti-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 CAPOX chemotherapy with pembrolizumab.
To determine the 5-month PFS of Pembrolizumab in combination with CAPOX in patients with advanced biliary tract carcinoma.
- 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.
The proposed study is a phase II study of Pembrolizumab in combination with CAPOX in patients with advanced biliary tract carcinoma
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||June 14, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: 1/Arm 1
Pembrolizumab plus Oxaliplatin plus Capecitabine
Biological: Pembrolizumab (MK-3475)
200 mg will be administered as an IV infusion on Day 1 of each 21 day cycle
130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6
750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6
- 5-month [ Time Frame: 5 Months ]Median amount of time subject survives without disease progression for 5 months after treatment
- safety [ Time Frame: 30 Days After Enrollment ]List of adverse event frequency
- response rate [ Time Frame: Every 9 Weeks ]Proportion of patients obtaining CR and PR per RECIST 1.1 criteria of all evaluable patients
- overall survival [ Time Frame: Death ]Median amount of time subject survives after therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111732
|Contact: Suzanne Fioravanti, R.N.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Tim F Greten, M.D.||National Cancer Institute (NCI)|