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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

Must not have

History of leptomeningeal carcinomatosis

History of another primary malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer spread to the lining of my brain and spinal cord.

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I have had another type of cancer.

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I experience significant numbness or pain in my hands or feet.

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I have not had liver-related brain issues or needed medicine for it in the last year.

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I have no medical reasons preventing me from undergoing embolization.

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I have an active skin condition.

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I weigh less than 30 kg.

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I do not have any severe illnesses that my doctors are still trying to get under control.

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My liver cancer has spread within the liver or beyond.

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I am not pregnant or breastfeeding.

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I have previously been treated with specific immunotherapies in a study.

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I have no lasting side effects from previous cancer treatments.

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I have a history of bleeding disorders.

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I have a serious heart condition.

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I do not have an active infection like TB, HIV, or hepatitis.

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I have an underactive thyroid.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR) using modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.

Secondary study objectives

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%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3750

Tremelimumab (Cohort A dose)

2019

Completed Phase 2

~30