Trial Summary
What is the purpose of this trial?This phase I trial is to find out the best dose, possible benefits, and/or side effects of hypofractionated radiation therapy and bintrafusp alfa in treating patients with bile duct cancer that has spread to other places in the body (advanced intrahepatic cholangiocarcinoma). Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Immunotherapy with bintrafusp alfa, a bifunctional fusion protein composed of the monoclonal antibody avelumab and TGF-beta, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The combination of hypofractionated radiation therapy and bintrafusp alfa may help to control intrahepatic cholangiocarcinoma.
Eligibility Criteria
This trial is for adults with advanced bile duct cancer who have tried at least one chemotherapy or refused it. They must have two measurable tumors, be in good physical condition, and agree to use birth control. People can't join if they have autoimmune diseases, recent infections requiring antibiotics, major surgery within 4 weeks, received certain treatments recently, untreated brain metastases, are pregnant or breastfeeding.Inclusion Criteria
Total bilirubin < 1.5 x institutional upper limit of normal (IULN)
I am fully active or have minor restrictions in physical activity.
I have undergone or refused initial chemotherapy.
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Exclusion Criteria
Patients who are pregnant or lactating
I have not had major bleeding in the last 4 weeks.
I haven't taken cancer drugs in the last 21 days and don't have major side effects from past treatments.
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Participant Groups
The trial tests a combination of hypofractionated radiation therapy (higher doses over a short period) and bintrafusp alfa (an immunotherapy drug). It aims to find the best dose and see how well this combo works against advanced intrahepatic cholangiocarcinoma by helping the immune system attack cancer.
1Treatment groups
Experimental Treatment
Group I: Treatment (hypofractionated radiation, bintrafusp alfa)Experimental Treatment3 Interventions
Patients undergo hypofractionated radiation therapy QD on weekdays (Monday-Friday) for 15 fractions in the absence of disease progression or unacceptable toxicity. Beginning 1 week after completion of radiation therapy, patients receive bintrafusp alfa IV over 1 hour on day 1. Cycles repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Bintrafusp Alfa is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Bintrafusp Alfa for:
- Non-small cell lung cancer (NSCLC)
🇪🇺 Approved in European Union as Bintrafusp Alfa for:
- Biliary tract cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor