Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC)
- Conditions
- Liver CancerBiliary Tract NeoplasmsCholangiocarcinomaBile Duct CancerGallbladder Cancer
- Interventions
- Registration Number
- NCT03111732
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1/Arm 1 Pembrolizumab (MK-3475) Pembrolizumab plus Oxaliplatin plus Capecitabine 1/Arm 1 Capecitabine Pembrolizumab plus Oxaliplatin plus Capecitabine 1/Arm 1 Oxaliplatin Pembrolizumab plus Oxaliplatin plus Capecitabine
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) 5 Months Median amount of time subject survives without disease progression for 5 months after treatment. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.
- Secondary Outcome Measures
Name Time Method Number of Participants Obtaining a Complete Response (CR) and Partial Response (PR) Every 9 Weeks, until disease progression or patient is taken off the trial, whichever comes first, approximately 36 weeks. Number of participants obtaining CR and PR per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria of all evaluable patients. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions,taking as reference the baseline sum of diameters.
Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Pembrolizumab 30 Days After Enrollment Here is the number of participants with grade 1-4 adverse events unrelated, unlikely, possibly, probably and definitely related to study drug assessed by the Common Terminology Criteria for Adverse Events v4.0. Mild (Grade1), moderate (Grade 2), severe (Grade 3), and life-threatening or disabling (Grade 4).
Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Oxaliplatin 30 Days After Enrollment Here is the number of participants with grade 1-4 adverse events unrelated, unlikely, possibly, probably and definitely related to study drug assessed by the Common Terminology Criteria for Adverse Events v4.0. Mild (Grade1), moderate (Grade 2), severe (Grade 3), and life-threatening or disabling (Grade 4).
Overall Survival Death, approximately 48 weeks after stopping therapy. Median amount of time subject survives after therapy.
Number of Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, and Probably Related to Capecitabine 30 Days After Enrollment Here is the number of participants with grade 1-4 adverse events unrelated, unlikely, possibly, and probably related to study drug assessed by the Common Terminology Criteria for Adverse Events v4.0. Mild (Grade1), moderate (Grade 2), severe (Grade 3), and life-threatening or disabling (Grade 4).
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States