Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
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)
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