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Checkpoint Inhibitor
Durvalumab + Tremelimumab for Liver Cancer
Phase 1
Recruiting
Led By Daneng Li
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients
Eastern Cooperative Oncology Group (ECOG) 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects of two cancer-fighting antibodies and their effectiveness in treating patients with liver cancer that has spread too far to be removed by surgery.
Who is the study for?
This trial is for adults with advanced liver cancer that can't be removed by surgery and hasn't spread beyond the liver. Candidates must have a life expectancy of at least 12 weeks, measurable disease, adequate organ function, no history of certain treatments or conditions that could interfere with the study, and agree to use contraception if applicable.Check my eligibility
What is being tested?
The trial tests Durvalumab and Tremelimumab after radioembolization in patients with unresectable liver cancer. These lab-made antibodies may boost the immune system's ability to fight cancer following targeted radiation therapy aimed at liver tumors.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, infusion reactions similar to allergic responses, fatigue, changes in blood counts which can affect overall health and increase infection risk. Each patient's experience may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am post-menopausal or have a negative pregnancy test if pre-menopausal.
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I am fully active or have some restrictions but can still care for myself.
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My body weight is over 30 kg.
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I am fully active or can carry out light work.
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My liver cancer cannot be removed by surgery and is at an intermediate or advanced stage without spreading outside the liver.
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I have at least one tumor that can be measured.
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My kidney function, measured by creatinine clearance, is above 40 mL/min.
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My liver cancer cannot be removed by surgery and is at an intermediate or advanced stage without spreading outside the liver.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicity
Incidence of adverse events
Overall response
Secondary outcome measures
Median progression-free survival
Overall survival
Progression-free survival
Other outcome measures
Gene expression signatures
Genomic alterations/evolutions
PD-L1 expression in baseline tumor biopsies
+1 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (durvalumab, tremelimumab)Experimental Treatment2 Interventions
Patients undergo standard of care radioembolization with Yttrium-90 SIR-spheres intra-arterially over 60-90 minutes on day -14. Patients then receive durvalumab IV over 1 hour and tremelimumab IV over 1 hour on day 1. Cycles with durvalumab repeat every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Tremelimumab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,428 Total Patients Enrolled
4 Trials studying Liver Cancer
134 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,041 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Daneng LiPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
2 Previous Clinical Trials
608 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function is classified as Child-Pugh A.I am post-menopausal or have a negative pregnancy test if pre-menopausal.I am fully active or have some restrictions but can still care for myself.My cancer has spread to other parts of my body.My body weight is over 30 kg.I haven't taken immunosuppressive drugs in the last 14 days.My doctor has recommended radioembolization for my condition.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.My hepatitis B is stable, as confirmed by my doctor.I received my last cancer treatment less than 28 days ago.I am fully active or can carry out light work.I am willing and able to follow the study's treatment and visit schedule.I can sign and agree to follow the study's rules as explained in the consent form.You are expected to live for at least 12 weeks.My liver cancer cannot be removed by surgery and is at an intermediate or advanced stage without spreading outside the liver.I have received an organ transplant from another person.I am a woman under 50, considered post-menopausal due to no periods for 12 months, hormone levels, or surgery.I currently have an active infection, including TB.You are expected to live for at least 12 more weeks.I am a woman over 50 and have not had a period for at least a year due to menopause or surgery.I have not had major surgery in the last 28 days.I am a man who is either surgically sterile or using contraception if my partner can still have children.I have at least one tumor that can be measured.My liver cancer affects more than half of my liver.I am a woman under 50, considered post-menopausal due to no periods for 12 months, hormone levels, or surgery.I have not received a live vaccine in the last 30 days.You are allergic to any of the study drugs or ingredients used to make them.I am not pregnant or breastfeeding and willing to use birth control during and up to 90 days after treatment.I am a male and not willing to use contraception.My liver is functioning well, according to a recent test.I have hepatitis C but haven't treated it, or I've successfully treated it and 4 weeks have passed since my treatment ended.My lung has a shunt over 10% or is expected to receive more than 30 Gy of radiation.I am not postmenopausal or surgically sterile and agree to use birth control.I have had cancer spread to the lining of my brain and spinal cord.My kidney function, measured by creatinine clearance, is above 40 mL/min.My liver cancer cannot be removed by surgery and is at an intermediate or advanced stage without spreading outside the liver.I am a woman over 50 and considered post-menopausal due to no periods for over a year or surgical sterilization.I do not have any unmanaged ongoing illnesses.My liver cancer has spread to major blood vessels or the heart.I have been treated with specific immune therapies before.I am not currently on any cancer treatments like chemotherapy or hormone therapy.I have or had an autoimmune or inflammatory disorder.I have had cancer before, but it was a type that is allowed in this study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (durvalumab, tremelimumab)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What additional research has been carried out on Durvalumab?
"Currently, 340 Durvalumab studies are ongoing. Of those, 52 have entered into Phase 3 and there is a grand total of 13098 clinical sites running these trials. Significant concentrations of studying centres can be found in Cordoba, Texas."
Answered by AI
Is this a previously unexplored experiment?
"To date, 340 ongoing trials have been conducted on Durvalumab in 1327 cities across 58 nations. The first one was commissioned by AstraZeneca back in 2007 and included a Phase 2 drug approval stage with 37 participants. Since then, an additional 123 experiments have been completed."
Answered by AI
To what extent can Durvalumab endanger individuals?
"The safety of Durvalumab has been given a rating of 1, as this is an early stage trial with the limited data backing its efficacy and security."
Answered by AI
In what particular scenarios is Durvalumab often prescribed?
"Durvalumab is used to combat unresectable stage iii non-small cell lung cancer, as well as advance directives and previously untreated metastatic ureter urothelial carcinoma."
Answered by AI
Is participation in this trial open and available to the public?
"Evidenced on clinicaltrials.gov, this research is actively seeking volunteers for participation; the trial first went up on August 3rd 2021 and has subsequently been updated as recently as August 15th 2022."
Answered by AI
How many volunteers have been maxed out in this research project?
"Affirmative. Clinicaltrials.gov verifies that this experiment is actively recruiting patients, which began on August 3rd 2021 and was last adjusted on the 15th of August 2022. This research requires 32 individuals to be selected from one medical site."
Answered by AI
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