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Checkpoint Inhibitor

Durvalumab + Tremelimumab after DEB-TACE for Liver Cancer

Phase 2
Waitlist Available
Led By Ana De Jesus-Acosta, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Have disease that responds to DEB-TACE
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test a new cancer treatment involving two drugs and a medical procedure. The goal is to see if it is safe and effective for people with liver cancer.

Who is the study for?
This trial is for adults over 18 with newly diagnosed liver cancer (HCC) who can undergo a specific type of chemoembolization, have good organ function and performance status, and are not pregnant. Excluded are those with widespread HCC, certain infections or conditions, recent major surgery or immunotherapy, live vaccines taken recently, under 30 kg in weight, or any involvement in the study's planning.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of combining two immunotherapies—Durvalumab and Tremelimumab—with DEB-TACE chemoembolization on patients with intermediate-stage liver cancer. Patients receive different doses of Tremelimumab to evaluate its impact alongside Durvalumab.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that may affect organs like the liver or intestines, infusion reactions from drug administration, fatigue, skin issues such as rash or itching; each person's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My condition responds to a specific liver cancer treatment.
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I weigh more than 30 kilograms.
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I have been recently diagnosed with liver cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am willing to have a liver biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR) using modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
Secondary outcome measures
Number of participants experiencing study drug-related toxicities
Overall Survival (OS)
Progression free survival (PFS)
+1 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Urinary tract infection
20%
Dyspnea
18%
Rash maculo-papular
15%
Abdominal Pain
15%
Back pain
15%
Weight gain
15%
Cough
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Anal pain
8%
Dry skin
8%
Urinary frequency
8%
Edema limbs
8%
Flatulence
8%
Myalgia
8%
Hot flashes
8%
Thromboembolic event
8%
Fever
8%
Colitis
8%
Dry mouth
8%
Headache
8%
Small intestinal obstruction
8%
Urinary tract pain
5%
Ascites
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Confusion
5%
Gastroesophageal reflux disease
5%
Anemia
5%
Urinary urgency
5%
Vaginal hemorrhage
5%
Sinus bradycardia
5%
Hypomagnesemia
5%
Rash acneiform
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Upper respiratory infection
3%
Rectal hemorrhage
3%
CPK increased
3%
Fall
3%
Skin infection
3%
Muscle weakness left-sided
3%
Myositis
3%
Hyperglycemia
3%
Peripheral sensory neuropathy
3%
Colonic perforation
3%
Pain in extremity
3%
Blood bilirubin increased
3%
Rectal pain
3%
Weight Loss
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Creatinine increased
3%
Lethargy
3%
Left ventricular systolic dysfunction
3%
Dysarthria
3%
Hypothyroidism
3%
Myocarditis
3%
Pleural effusion
3%
Hyperkalemia
3%
Generalized muscle weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Durvalumab in combination with Tremelimumab (Cohort B dose)Experimental Treatment2 Interventions
Starting at week 2, after initial DEB-TACE treatment, patients will receive Durvalumab in combination with tremelimumab as specified per protocol (Cohort B dose). Treatment will continue for up to 12 months, while receiving DEB-TACE. Repeat DEB-TACE will be provided Q8W if there is residual tumor that can be targeted.
Group II: Durvalumab in combination with Tremelimumab (Cohort A dose)Experimental Treatment2 Interventions
Starting at week 2, after initial DEB-TACE treatment, patients will receive Durvalumab in combination with tremelimumab, as specified per protocol (Cohort A dose). Treatment will continue for up to 12 months, while receiving DEB-TACE. Repeat DEB-TACE will be provided Q8W if there is residual tumor that can be targeted.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
554 Previous Clinical Trials
32,881 Total Patients Enrolled
3 Trials studying Liver Cancer
144 Patients Enrolled for Liver Cancer
AstraZenecaIndustry Sponsor
4,237 Previous Clinical Trials
288,449,645 Total Patients Enrolled
2 Trials studying Liver Cancer
1,040 Patients Enrolled for Liver Cancer
Ana De Jesus-Acosta, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2 Previous Clinical Trials
121 Total Patients Enrolled

Media Library

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03638141 — Phase 2
Liver Cancer Research Study Groups: Durvalumab in combination with Tremelimumab (Cohort A dose), Durvalumab in combination with Tremelimumab (Cohort B dose)
Liver Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03638141 — Phase 2
Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03638141 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Durvalumab been given the green light for utilization by the Food and Drug Administration?

"Based on our internal assessment, the safety of Durvalumab was graded a 2 due to pre-existing clinical evidence that supports its security. Unfortunately, there is currently no data available to demonstrate efficacy."

Answered by AI

Are any individuals aged eighty-five or older admitted to this investigation?

"This trial seeks to recruit participants in the age range of 18-75 years. For patients below this lower limit, there are 91 clinical trials available and for those above it, 2923 medical studies have been posted."

Answered by AI

How many individuals are actively taking part in this experiment?

"Affirmative. The clinical trial registry on clinicialtrials.gov showcases that this study, which was posted October 2nd 2019, is seeking participants at the moment. The project needs to enlist 30 individuals from a single medical centre."

Answered by AI

Am I eligible to participate in this experiment?

"This clinical study seeks 30 individuals aged 18 to 75 with liver carcinoma. To be eligible, prospective patients must fulfill the requirements of a signed informed consent form, have measurable disease that responds to DEB-TACE treatment, an ECOG performance status between 0 and 1, body weight over 30kg, evidence of ascites scoring below 7 on radiographic tests, as well as adequate organ function defined by laboratory analysis. Furthermore, women must provide proof of postmenopausal status or negative pregnancy test results."

Answered by AI

Is the recruitment for this clinical trial ongoing?

"According to clinicaltrials.gov, this experiment is still seeking participants. It was first advertised on October 2nd of 2019 and has most recently been updated on the 6th of October 2022."

Answered by AI

What has Durvalumab been indicated for in clinical practice?

"Durvalumab is widely used to treat advanced, inoperable stage III non-small cell lung cancer and also has some success with metastatic ureteral carcinoma as well other malignancies."

Answered by AI

Could you elucidate any other trials that have been conducted using Durvalumab?

"Presently, 340 clinical trials researching Durvalumab are ongoing with 52 in the final phase. While Cordoba, Texas has a notably high concentration of these studies, there are over 13 thousand sites across the world conducting research for this medication."

Answered by AI

Is this trial a revolutionary exploration into medical treatment?

"Currently, 340 clinical trials involving Durvalumab are ongoing in 1327 cities and 58 nations. The first trial of this drug was conducted by AstraZeneca back in 2007 with 37 participants; since then 123 follow-up studies have been done to reach Phase 2 approval status."

Answered by AI
~3 spots leftby Sep 2024