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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Advanced Biliary Tract Cancer

In brief

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

Key facts

Study ID

NCT04781192

Run by

University of Kansas Medical Center

People needed

40

Starts

2022-03-22

Expected to finish

2026-12-01

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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:

Where it is running

• University of Kansas Cancer Center - Overland Park — Overland Park, Kansas, United States
• The University of Kansas Medical Center — Westwood, Kansas, United States
• University of Kansas Cancer Center - North — Kansas City, Missouri, United States
• University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States
• The University of Kansas Medical Center — North Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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