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Monoclonal Antibodies

Radiation + Immunotherapy for Bile Duct Cancer

Phase 1

Waitlist Available

Led By Eugene J Koay

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky > 70)

Patients must have received at least one standard first-line chemotherapy regimen or have refused chemotherapy

Must not have

Major bleeding in the last 4 weeks

Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication or any unresolved toxicity (> grade 1) from previous anticancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity. Prior treatment with nitrosoureas (e.g., carmustine or lomustine) require a 6-week washout prior to the first dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is to find the best dose of radiation and a new immunotherapy drug for bile duct cancer that has spread.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include typical reactions from radiation like skin irritation and fatigue as well as immune-related effects from bintrafusp alfa such as flu-like symptoms, potential organ inflammation due to an overactive immune response, and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or have minor restrictions in physical activity.

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I have undergone or refused initial chemotherapy.

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I am 18 years old or older.

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My kidney function, measured by creatinine levels or clearance, is normal.

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My liver function tests are within the required range.

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I have bile duct cancer with at least two tumors that can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major bleeding in the last 4 weeks.

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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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I have an autoimmune disease or am receiving treatment for one.

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I have previously received treatments that boost the immune system to fight cancer.

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I haven't had cancer treatment or experimental therapy in the last 2 weeks.

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I do not have uncontrolled heart problems or a recent heart attack.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AEs)

Secondary study objectives

Local progression free survival (LPFS)

Objective response rate

Overall survival (OS)

+1 more

Other study objectives

Biomarker analysis

Side effects data

From 2023 Phase 3 trial • 107 Patients • NCT03324802

80%

Dermatitis radiation

54%

Skin hyperpigmentation

48%

Pain

35%

Lymphedema

22%

Superficial soft tissue fibrosis

Skin hypopigmentation

Edema limbs

Device related infection

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1 (Radiation Therapy, 15 Fractions)

Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated Radiation Therapy

2016

Completed Phase 3

~130

Biopsy

2014

Completed Phase 4

~1090