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PD-L1 Inhibitor
Regorafenib + Durvalumab for Biliary Tract Cancer
Phase 1 & 2
Recruiting
Led By Raed Al-Rajabi, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of treatment to eot or 2 years (end of study), whichever occurs first
Awards & highlights
No Placebo-Only Group
Summary
This trial will test how well combining Durvalumab and Regorafenib works for participants with biliary track cancer who have had one prior treatment.
Who is the study for?
This trial is for adults with advanced biliary tract cancers that have worsened after one prior treatment. Participants must be able to swallow pills, have a life expectancy of at least 3 months, and an ECOG performance status of 0-1 (fully active or restricted in physically strenuous activity but ambulatory). They should not have had cancer therapy within the last 21 days and must use effective contraception.
What is being tested?
The study tests the combination of Durvalumab and Regorafenib on patients with advanced stage biliary tract carcinoma who've already tried one treatment without success. The goal is to see if this drug duo can safely improve their condition.
What are the potential side effects?
Potential side effects include fatigue, high blood pressure, bleeding issues, immune-related reactions like inflammation in organs or skin problems, liver enzyme changes indicating potential liver damage, and increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of treatment to eot or 2 years (end of study), whichever occurs first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of treatment to eot or 2 years (end of study), whichever occurs first
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 related adverse events
Progressin Free Survival (PFS)
Secondary study objectives
Disease Control Rate (DCR)
Overall Response (OR)
Overall Response Rate (ORR)
+1 moreAwards & 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: Dose Finding RegorafenibExperimental Treatment2 Interventions
We 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3750
Regorafenib
2014
Completed Phase 2
~1600
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
510 Previous Clinical Trials
176,859 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
22 Patients Enrolled for Cholangiocarcinoma
Raed Al-Rajabi, MDPrincipal InvestigatorUniversity of Kansas Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any major abdominal issues like a fistula or obstruction in the last 8 weeks.I do not have any serious ongoing illnesses like heart failure or lung disease.My condition worsened after at least one treatment.I have been treated with immune checkpoint inhibitors before.My organ functions are within normal ranges according to recent tests.I have an active autoimmune disease and have been treated for it in the last 2 years.I have been treated with regorafenib before.I have HIV, and/or active hepatitis B or C but am receiving treatment.I have severe diarrhea due to a condition like Crohn's disease.I received my last cancer treatment less than 3 weeks ago.I have not had significant bleeding episodes in the last 8 weeks.I don't have lasting side effects from cancer treatment, except for mild neuropathy, hair loss, or skin changes.I have had an organ transplant.I use herbal remedies.I haven't had any other cancer besides my current one in the last 3 years.I do not have a serious ongoing infection.My protein levels in urine are not extremely high.I do not have an active tuberculosis infection.I will stay on antiviral therapy during and 6 months after the study if needed.I have hepatitis C antibodies but no active virus according to PCR tests.I weigh more than 66 lbs.I agree not to donate sperm during and for 6 months after the study.I have fluid buildup that can't be managed with treatment.I have hepatitis B and am on antiviral therapy to control it.I have at least one tumor that can be measured and tracked over time.I am on blood thinners and have stable blood clotting measures.I am fully active or can carry out light work.My blood pressure is high despite taking medication.I or my legal representative can understand the study and agree to sign the consent.I can swallow pills and take my own medication.I haven't had a live vaccine in the last 30 days.I have untreated brain metastases or cancer in the lining of my brain, stable for over 4 weeks.My bile duct or gallbladder cancer can't be surgically removed and has worsened after one treatment.I have recovered from major side effects of my previous treatments.I am not on strong immune system suppressing drugs, except for minor exceptions like inhalers.I have been diagnosed with ampullary carcinoma.I haven't had a stroke, heart attack, or blood clot in the last 4 weeks.I am not on cancer treatment drugs, but I may be on hormone therapy for other reasons.I have fully healed from any major surgery at least 1 month ago, or from minor surgery at least 10 days ago, with no ongoing complications.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Finding Regorafenib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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