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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

Must not have

Any evidence of known metastatic disease

Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) =< 28 days prior to the first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

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

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My cancer has spread to other parts of my body.

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I received my last cancer treatment less than 28 days ago.

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I have received an organ transplant from another person.

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I currently have an active infection, including TB.

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I have not had major surgery in the last 28 days.

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My liver cancer affects more than half of my liver.

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I am a male and not willing to use contraception.

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My lung has a shunt over 10% or is expected to receive more than 30 Gy of radiation.

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I am not postmenopausal or surgically sterile and agree to use birth control.

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

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I do not have any unmanaged ongoing illnesses.

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My liver cancer has spread to major blood vessels or the heart.

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I have been treated with specific immune therapies before.

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I am not currently on any cancer treatments like chemotherapy or hormone therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Dose-limiting toxicity

Incidence of adverse events

Overall response

Secondary study objectives

Median progression-free survival

Progression-free survival

Other study objectives

Gene expression signatures

PD-L1 expression in baseline tumor biopsies

Tumor mutational burden

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

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

0 / 22Eligibility criteria met