Actively Recruiting
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
Led by National Cancer Institute (NCI) · Updated on 2026-03-24
60
Participants Needed
1
Research Sites
942 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Biliary tract carcinoma (BTC) is cancer of the slender tubes that carry fluids in the liver. People with advanced BTC have few treatment options, and their survival rates are very low. Objective: To test a study drug (CDX-1140) combined 3 other drugs (capecitabine, oxaliplatin, Keytruda) in people with BTC. Eligibility: Adults aged 18 years or older with BTC that progressed after treatment and is not eligible for surgery or liver transplant. Design: Participants will be screened. They will have a physical exam. They will have blood tests and tests of their heart function. They will have imaging scans. They may need to have a biopsy: A small sample of tissue will be taken from their tumor using a small needle. Three of the drugs are given through a tube attached to a needle inserted into a vein in the arm (intravenous). The fourth drug is a pill taken by mouth with water. Participants will be treated in 21-day cycles. They will receive intravenous treatments on day 1 and day 8 of the first 6 cycles. After that, they will receive intravenous treatments only on day 1 of each cycle. Participants will take the pill twice a day only for the first 2 weeks of each cycle. They will stop taking this drug after 6 cycles. Imaging scans will be repeated every 9 weeks. Participants may continue receiving the study treatment for up to 2 years. Follow-up visits, including imaging scans, will continue for 3 more years. These images may be taken at other locations and sent to the researchers.
CONDITIONS
Official Title
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological confirmation of biliary tract carcinoma or carcinoma with clinical and radiological features strongly suggesting BTC
- Maximum tumor size of any tumor or metastasis must be 8 cm or less
- Disease has progressed after first-line standard treatment or patient refused standard treatment
- Disease not suitable for curative surgery or liver transplant
- Measurable or evaluable disease according to RECIST 1.1 criteria
- ECOG performance status of 0 to 1
- Adequate organ and bone marrow function with neutrophil count at least 1,000/mcL
- Platelets at least 100,000/mcL
- Total bilirubin up to 2.5 times upper limit of normal (ULN)
- ALT and AST up to 5 times ULN
- Creatinine less than 1.5 times ULN or creatinine clearance at least 45 mL/min/1.73 m2 if creatinine elevated
- Age 18 years or older
- Recovery from acute toxicity from prior treatment to grade 1 or less
- Use of adequate contraception for individuals able to have children during and after study treatment
- Nursing participants willing to stop nursing from start of treatment through 4 months after discontinuation
- HBV-infected participants on antivirals with HBV DNA under 100 IU/mL
- HCV-infected participants with undetectable HCV RNA
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Received any standard or investigational anti-cancer therapy within 4 weeks before treatment start
- Prior treatment with anti-CD40 therapy
- Received live vaccines within 30 days before treatment start
- Major surgery within 4 weeks before treatment start
- Active central nervous system metastases or carcinomatous meningitis
- HIV infection
- History or current pneumonitis
- Allergic reactions to similar study drugs or agents
- Prior invasive cancers within 3 years except certain skin, bladder, or prostate cancers
- Medical conditions requiring chronic systemic steroid or immunosuppressive therapy
- History of chronic autoimmune or connective tissue diseases with symptoms within 3 years
- QTcF interval 480 msec or higher or risk factors for arrhythmia
- Unable to tolerate prior immune checkpoint inhibitor therapy
- Uncontrolled illness or psychiatric/social issues limiting study compliance
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
D
Donna Hrones, C.R.N.P.
CONTACT
T
Tim F Greten, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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