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Advanced Biliary Tract CancerPhase 1/2NCT04781192

The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective in Treatment of Chemo Refractory Advanced Biliary Tract Cancers

A Phase 1/2 study testing Durvalumab and Regorafenib in people with Advanced Biliary Tract Cancer, run by University of Kansas Medical Center at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to measure how effective combining Durvalumab and Regorafenib will be for participants with advance stage biliary track carcinoma who have received one line of prior treatment Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Biliary Tract Cancer
What is being tested?
Durvalumab and Regorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesUnited States
Study dates
22 Mar 2022to Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability of patient OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  • Can swallow tablets and self-administer medication
  • Progressed on at least one line of therapy (no restrictions on type of previous treatment)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 - 1
  • Measurable disease with at least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline. Previously irradiated lesion cannot be considered as Target Lesion (TL) except in cases of documented progression of the lesion since the completion of radiation therapy
  • Histologically confirmed unresectable or metastatic intrahepatic/extrahepatic cholangiocarcinoma or gallbladder cancer with radiographic progression, who have progressed on one line of therapy / failed adjuvant therapy
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  • Life expectancy of at least 3 months
  • Recovery to baseline or < Grade 2 CTCAE v5.0 from toxicities related to any prior treatments, unless adverse event's (AE(s)) are clinically nonsignificant and/or stable on supportive therapy
  • Adequate organ function per laboratory results
  • Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) will be allowed provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until international normalized ratio/ partial thromboplastin time (INR/PTT) is stable based on a measurement that is pre-dose as defined by the local standard of care
  • Weight > 30 kg (66 lbs)
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to use an acceptable form of contraception for the duration of study participation, and for 7 months after the last study treatment
  • Men of child-bearing potential must agree not to donate sperm while on this study and for 180 days (6 months) after the last dose of study treatment

Who cannot join

  • Current or anticipated use of other investigational agents while participating in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breastfeeding
  • Ampullary carcinoma
  • Previous treatment with regorafenib
  • Previous treatment with a programmed death 1 (PD1), programmed death-ligand (PD-L1, including durvalumab), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, or agent directed to another co-inhibitory T cell receptor
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  • Previous treatment with live vaccine within 30 days of planned start of study drugs (seasonal flu vaccines that do not contain a live virus are permitted)
  • Active autoimmune disease (active defined as having autoimmune disease related symptoms and detectable autoantibodies) that has required systemic treatment in the past 2 years
  • Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drugs. Except Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection), systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent, steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies). Dual active hepatitis B virus (HBV) infection (HBsAg (+) and /or detectable HBV DNA) and HCV infection (anti-HCV Ab(+) and detectable HCV RNA) at study entry. Single active infection of HBV or HCV infection is allowed with treatment by local standards
  • Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on the baseline brain imaging, unless known and treated with stable for >4 weeks
  • Significant acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, malabsorption, or CTCAE Grade ≥ 2 diarrhea of any etiology
  • Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤ 21 days prior to the first dose of study drug
  • Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. However, the palliative radiation to non-targeted lesions is allowed
  • Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 8 weeks before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose
  • Uncontrollable ascites or pleural effusion
  • Clinically significant gross hematuria, hematemesis, or hemoptysis of >0.5 tsp (2.5ml) of red blood, or other history of grade 3 significant bleeding within 8 weeks
  • Any unresolved toxicity NCI CTCAE v 5.0 Grade ≥2 from previous anticancer therapy with the exception of neuropathy grade 2 and below, alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  • Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before first dose and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days before first dose. Patients with clinically relevant ongoing complications from prior surgery are not eligible
  • History of organ transplantation
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease
  • Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment
  • Mean QT interval corrected for heart rate (QTcF) >470 ms calculated from 3 electrocardiograms (ECGs) (within 15 minutes at 5 minutes apart) using Fridericia's Correction
  • Stroke (including transient ischemic attack transient ischemic attack (TIA), myocardial infarction (MI), or other ischemic event, or acute thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) that are NOT asymptomatic with local standard anti-coagulation within 4 weeks before first dose
  • History of another primary malignancy in the last 3 years except:
  • Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of IP and of low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease
  • Use of any Herbal remedy
  • Ongoing infection >grade 2
  • Known allergy or hypersensitivity to any of the study drugs
  • Proteinuria > Grade3 (>3.5g/24 hours)
  • Active infection with tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice)
  • Participants with HBV infection (as characterized by positive hepatitis B surface antigen [HBsAg] and/or anti-hepatitis B core antibodies (anti-HBc) with detectable HBV deoxyribonucleic acid (DNA) [≥10 international units (IU)/mL or above the limit of detection per local laboratory]) must receive antiviral therapy prior to randomization to ensure adequate viral suppression
  • Participants must remain on antiviral therapy for the study duration and for 6 months after the last dose of study treatment. Participants who test positive for anti-HBc with undetectable HBV DNA (<10 IU/mL or under the limit of detection per local laboratory) do not require antiviral therapy unless HBV DNA exceeds 10IU/mL or reaches detectable limits per local laboratory during the course of treatment
  • Patients positive for hepatitis C (HCV) antibody. EXCEPTIONS: Patients positive for hepatitis C (HCV) are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Patients positive for hepatitis C (HCV) are eligible if they undergo treatment per local guidelines

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • The University of Kansas Medical Center

    North Kansas City, Missouri, 64116

  • University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210

  • The University of Kansas Medical Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: Phase I/II Clinical Trial of Regorafenib Plus Durvalumab (MEDI4736) in Patients With Chemo Refractory Advanced Biliary Tract Cancers

The purpose of this study is to measure how effective combining Durvalumab and Regorafenib will be for participants with advance stage biliary track carcinoma who have received one line of prior treatment

Being tested
Durvalumab, Regorafenib
Keywords
Chemo-refractory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    Intra-Venous(IV) once every 28 days (approximately every 4 weeks [q4w])

  • RegorafenibDrug

    Oral once per day, Days 1 - 21 every 28 days

Study groups in NCT04781192
Study groupRoleWhat they receive
Dose Finding RegorafenibExperimentalWe will use a 3 + 3 design with two dose levels of 80 mg and 120 mg to discover the Maximum Tolerated Dose (MTD) for regorafenib
Receives: Drug: Durvalumab; Drug: Regorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment related adverse events

    CTCAE Version 5.0

    Measured: At the end of cycle 1 (each cycle is 28 days) until 30 days after end of treatment (EOT)

  2. Progressin Free Survival (PFS)

    RECIST Version 1.1

    Measured: At the end of each cycle (28 days) until disease progression or 2 years (end of study), whichever occurs first

Secondary outcomes (4)

  1. Overall Response (OR)

    RECIST Version 1.1

    Measured: Start of treatment to EOT or 2 years (end of study), whichever occurs first

  2. Disease Control Rate (DCR)

    RECIST Version 1.1

    Measured: Start of treatment to EOT or 2 years (end of study), whichever occurs first

  3. Overall Response Rate (ORR)

    RECIST Version 1.1

    Measured: Start of treatment to EOT or 2 years (end of study), whichever occurs first

  4. Overall Survival (OS)

    RECIST Version 1.1

    Measured: Start of treatment to EOT or 2 years (end of study), whichever occurs first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2021
  2. Study start22 Mar 2022
  3. Primary completion12 Nov 2025
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm, unblinded phase I/II study with safety dose-finding in Phase I followed by efficacy determination in Phase II if maximum tolerated dose (MTD) is found in Phase I.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04781192
Sponsor's protocol ID
IIT-2020-RegoDurva
Status last verified
Jan 2026
First submitted
25 Feb 2021
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Durvalumab and Regorafenib in people with Advanced Biliary Tract Cancer, run by University of Kansas Medical Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment related adverse events (time frame: At the end of cycle 1 (each cycle is 28 days) until 30 days after end of treatment (EOT)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04781192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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