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Checkpoint Inhibitor

Radioembolization + Immunotherapy for Bile Duct Cancer

Phase 1

Recruiting

Led By Umair Majeed, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Age >= 18 years with body weight > 30 kg

Histologically or cytologically confirmed, locally advanced intrahepatic cholangiocarcinoma that is not amenable to resection, transplantation, or thermal ablation. Oligometastatic intrahepatic cholangiocarcinoma is also eligible. Specifically, such patients must have EITHER =< 3 malignant extrahepatic lymph nodes (short axis diameter >= 3cm) OR metastatic lesions in one organ other than liver (if only single lesion is present diameter MUST be < 3cm, if up to 3 lesions in one organ each lesion MUST be =< 1cm)

Must not have

History of another primary malignancy except for:

Surgery =< 28 days prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if combining Y90 radioembolization with immunotherapy can help treat advanced, unresectable intrahepatic cholangiocarcinoma, a rare and aggressive cancer with few curative options.

Who is the study for?

This trial is for adults over 18 with locally advanced, unresectable intrahepatic cholangiocarcinoma who can't have curative therapy. They should be in good physical condition (ECOG PS 0 or 1), not pregnant, and without severe concurrent diseases or a history of multiple treatments for this cancer.

What is being tested?

The trial tests Y90 radioembolization combined with two monoclonal antibodies, tremelimumab and durvalumab. It aims to see if this combination is safe and effective at killing more tumor cells in patients who cannot undergo surgery.

What are the potential side effects?

Potential side effects include typical reactions to immunotherapy like fatigue, skin reactions, inflammation of organs as well as those related to radiation such as localized pain or damage to surrounding tissues.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 years old and weigh more than 30 kg.

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My bile duct cancer cannot be surgically removed and may have spread, but only a little.

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My liver is functioning well, with a Child-Pugh score A and ALBI grade 1 or 2.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer can be measured by tests.

Exclusion Criteria

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

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I have had cancer before, but it was a different type than my current diagnosis.

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I had surgery less than 28 days ago.

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I have not had chemotherapy in the last 4 weeks.

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I have had more than one treatment for cholangiocarcinoma, not counting adjuvant therapy.

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I have previously used cancer vaccines for treatment.

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My liver function is unstable or my Child Pugh score changed recently.

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My liver disease is moderately to severely advanced.

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My liver disease is severe (MELD score over 10).

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I cannot have or my tumor's blood supply is not suitable for a specific artery treatment.

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My treatment involves high radiation doses to my lungs.

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I am HIV positive and currently on antiretroviral therapy.

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I do not have active autoimmune or inflammatory disorders.

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I was treated for cancer with the goal of curing it, and I've been free of active disease for 5 or more years.

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I had skin cancer (not melanoma) treated and currently show no signs of it.

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My early-stage cancer was treated successfully with no current signs of it.

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I do not have any ongoing uncontrolled infections like TB, HIV, or hepatitis.

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I have a long-term stomach/intestine condition that causes diarrhea.

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I have symptoms of heart failure.

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I do not have unstable chest pain, irregular heartbeats, or uncontrolled high blood pressure.

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I need oxygen for my chronic lung condition.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have had a transplant from a donor.

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I haven't had a live vaccine in the last 30 days and won't need one during or shortly after the study.

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I have previously received immunotherapy targeting PD-1, PD-L1, PD-L2, or CTLA-4.

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I have lung spread or cancer in other body parts that is at least 1 cm big.

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I am not on any experimental drugs for my cancer.

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I understand the clinical trial's details and can consent.

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I cannot tolerate contrast agents even with medication.

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My blood pressure is not controlled by medication.

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I am using steroids that are inhaled, nasal, topical, or injected locally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months 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 Treatment-Emergent Adverse Events (Safety and Tolerability) (Cohort 1)

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (Cohort 2)

Secondary study objectives

Change in absolute monocyte count (AMC)

Change in absolute neutrophil count (ANC)

Change in absolute neutrophil count to absolute lymphocyte count (ANC:ALC) ratio

+10 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort II: (Y90, tremelimumab on day 14, cycle 1, durvalumab )Experimental Treatment9 Interventions

Patients receive transarterial Y90 radioembolization on day 1 of cycle 1 and receive tremelimumab IV over 1 hour on day 14 of cycle 1 and durvalumab IV over 1 hour on day 14 of each cycle. Cycles repeat every 42 days for cycle 1 and then every 28 days for cycles 2-24 in the absence of disease progression or unacceptable toxicity. Patients also undergo mapping angiography during screening, as well as CT and MRI or PET/CT during screening and on study. Patients also undergo blood sample collection throughout the trial and may undergo tumor biopsy during screening and on study.

Group II: Cohort I: (Y90, tremelimumab on day 1, cycle 1, durvalumab)Experimental Treatment9 Interventions

Patients receive transarterial Y90 radioembolization and tremelimumab IV over 1 hour on day 1 of cycle 1 and durvalumab IV over 1 hour on day 1 of each cycle. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo mapping angiography during screening as well as CT and MRI or PET/CT during screening and on study. Patients also undergo blood sample collection throughout the trial and may undergo tumor biopsy during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Angiography

2014

N/A

~1900