A Study of CDX-1140 with CAPOX and Keytruda for Biliary Tract Cancer
This study is testing a new combination of medicines for people with biliary tract cancer (BTC), a type of cancer in the tubes that carry fluids in the liver. The study combines CDX-1140 with capecitabine, oxaliplatin (CAPOX), and Keytruda (pembrolizumab). Researchers want to find a safe dose of CDX-1140 in combination with these other drugs and see how well this treatment prevents the cancer from growing for at least 6 months. They will also measure how many people respond to the treatment. You may be able to join if you are an adult (18-120 years old) with BTC that has progressed after other treatments and cannot be removed by surgery or liver transplant. The study aims to enroll 60 participants. The current status of the study is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It is planned to enroll 60 participants.
- What's involved
- You will have screening tests including a physical exam, blood tests, heart function tests, and imaging scans. You may also need a tumor biopsy. Treatments will be given in cycles every 21 days for up to 6 cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be monitored from the start of the study until your disease progresses or for up to 5 years after starting treatment, whichever comes first.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
At a glance
Conditions
NCT05849480
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
National Institutes of Health Clinical Center
Bethesda, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Tim F Greten, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Phase I: Safe dose of CDX-1140 in combination with CAPOX and Keytruda(R)35 days
Estimation of safe dose will be determined based on number of dose limiting toxicities (DLTs) experienced.
- Phase II: 6-month progression free survival (PFS) probabilityStudy start - 6 months after start of study drug
6-month PFS probability will be calculated using the Kaplan-Meier method.
- Phase II: Overall response rate (ORR)Study start until disease progression or 5 years after initiation of study therapy, whichever occurs first.
The fraction of participants who experience a response (PR + CR) evaluated every 9 (+/- 4) weeks. Results will be reported along with 80% and 95% two-sided confidence intervals.