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Checkpoint Inhibitor

Durvalumab + Tremelimumab + Radiation for Liver Cancer

Phase 2

Recruiting

Led By Theodore S. Hong, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance Status ≤ 1

Immunotherapy-naïve

Must not have

Major surgical procedure within 28 days prior to the first dose of IP

History of solid organ transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, start of cycle 3, start of cycle 5, and then the start of every subsequent 4-week cycle for the remainder of treatment (approximately 3 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of drugs as a possible treatment for liver or bile duct cancer. The interventions being studied are durvalumab, tremelimumab, and radiation therapy.

Who is the study for?

Adults with advanced liver or biliary tract cancer, who haven't had certain treatments and are not pregnant. They must have good organ function, no prior immunotherapy, and be able to follow the study plan. Those with hepatitis B or C need controlled infection levels.

What is being tested?

The trial is testing a combination of two drugs (Durvalumab and Tremelimumab) along with radiation therapy as a potential treatment for Hepatocellular Carcinoma or Biliary Tract Cancer.

What are the potential side effects?

Possible side effects include immune-related reactions that can affect organs, fatigue, skin rash, digestive issues like diarrhea, liver inflammation, hormone gland problems such as thyroid disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all my pre-disease activities without restriction.

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I have never received immunotherapy.

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I have hepatitis C confirmed by a specific blood test.

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My body weight is at least 30 kg.

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My cancer is confirmed to be liver or bile duct cancer.

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I am 18 years old or older.

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I have a cancer lesion that hasn't been treated with radiation and can receive specific radiotherapy, and another measurable lesion outside of this treatment area.

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My cancer did not respond or I cannot tolerate previous treatments like sorafenib for liver cancer.

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I know my hepatitis status and if positive for HBV, I am on antiviral medication.

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I have hepatitis B under control with treatment, and my viral load is low.

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My blood and organ functions are within the required ranges.

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My cancer cannot be removed by surgery and may have spread.

Exclusion Criteria

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

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

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I have had a solid organ transplant.

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I have had an autoimmune disease in the last 2 years.

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I have or had Crohn's disease or ulcerative colitis.

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I have not had any other cancer in the last 2 years.

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I do not have any severe illnesses that could interfere with the study.

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My liver cancer is a specific type (fibrolamellar, sarcomatoid, or mixed with bile duct cancer).

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The area needing radiation has been treated before.

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I have previously received immunotherapy treatments such as anti-CTLA4, anti-PD-1, or anti-PD-L1.

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I have not received any live vaccines in the last 30 days.

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I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.

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I have seizures that are not controlled by medication.

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I have cancer that has spread to my brain or spinal cord.

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I have had lung inflammation treated with steroids, or I have a lung condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, start of cycle 3, start of cycle 5, and then the start of every subsequent 4-week cycle for the remainder of treatment (approximately 3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, start of cycle 3, start of cycle 5, and then the start of every subsequent 4-week cycle for the remainder of treatment (approximately 3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, start of cycle 3, start of cycle 5, and then the start of every subsequent 4-week cycle for the remainder of treatment (approximately 3 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

Best Overall Response rate

Secondary study objectives

Disease Control Rate

Duration of Response

Number of Participants With Treatment Related Adverse Events

+3 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

1Treatment groups

Experimental Treatment

Group I: Tremelimumab + Durvalumab + RadiationExperimental Treatment3 Interventions

* Durvalumab via IV infusion every 28 days for up to 4 doses/cycles * Tremelimumab via IV infusion every 28 days for up to 4 doses/cycles, and then continue durvalumab monotherapy every 4 weeks starting on Week 16 for up to 8 months. * Radiation therapy will only be given during cycle 2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tremelimumab

Not yet FDA approved

Radiation

2003

Completed Phase 2

~780

Durvalumab

FDA approved