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Checkpoint Inhibitor

Sorafenib + Nivolumab for Liver Cancer

Phase 2

Waitlist Available

Led By Robin K. Kelley, MD

Research Sponsored by Robin Kate Kelley

Eligibility Criteria Checklist

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

Must have

Histologic or cytologic diagnosis of unresectable, locally advanced and/or metastatic hepatocellular carcinoma (HCC) not amenable to curative surgery, transplantation, or ablative therapies based upon assessment of treating investigator.

Radiographically measurable disease by RECIST version 1.1 in at least one site not previously treated with chemoembolization, radioembolization, radiation, or other local/liver-directed procedures (i.e. must have at least one measurable target lesion, either within the liver or in a measurable metastatic site); a new area of tumor progression within or adjacent to a previously-treated lesion, if clearly measurable by a radiologist, is acceptable.

Must not have

Known fibrolamellar or mixed HCC-cholangiocarcinoma histology

Active or clinically significant cardiac disease including: Congestive heart failure - NYHA > class II, Active coronary artery disease including unstable or newly diagnosed angina or myocardial infarction within 6 months prior to study entry, Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, Corrected QT interval (QTc) (Fridericia) > 450 msec on two consecutive ECGs (baseline ECG should be repeated if QTc is found to be > 450 msec)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs to treat patients with liver cancer.

Who is the study for?

Adults with liver cancer that can't be surgically removed, has spread locally or to other body parts. They must have measurable disease not treated by certain local therapies, adequate organ function, controlled blood pressure, and no recent major surgeries. Excluded are those with brain metastases, active infections like hepatitis B/C or HIV, uncontrolled heart conditions, prior systemic therapy for liver cancer or certain other cancers.

What is being tested?

The trial is testing the combination of Sorafenib (a drug blocking enzymes needed for cell growth) and Nivolumab (an immunotherapy antibody). It aims to find the best dose and observe side effects in patients with advanced liver cancer who haven't had surgery.

What are the potential side effects?

Possible side effects include high blood pressure from Sorafenib and immune-related reactions from Nivolumab such as inflammation in organs. Patients may also experience fatigue, digestive issues like diarrhea or loss of appetite, skin problems like rash or itching.

Eligibility Criteria

Inclusion Criteria

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

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My liver cancer cannot be removed or cured with surgery or other treatments.

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I have at least one cancer spot that can be measured and hasn't been treated locally.

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My liver cancer cannot be removed by surgery or cured with other treatments.

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I have a tumor that can be measured on scans and hasn't been treated with specific local procedures.

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I am 18 years old or older.

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My liver functions are within the required range for the study.

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My blood tests show enough neutrophils, platelets, and hemoglobin.

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I have cirrhosis or varices and have undergone the recommended endoscopy treatments.

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My blood pressure is 140/90 or lower, with or without medication.

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My liver function is moderately impaired.

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I am on antiviral therapy for HBV with a viral load under 500 IU/mL.

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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 fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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I can swallow and keep down pills.

Exclusion Criteria

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

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My cancer is a specific type called fibrolamellar or mixed HCC-cholangiocarcinoma.

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I do not have serious heart conditions like recent heart attacks or severe heart failure.

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I have both hepatitis B and either hepatitis D or C.

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My cancer has spread to the lungs and shows central or necrotic features.

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I need medication to prevent blood clots.

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I am not pregnant or breastfeeding.

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I can follow the study plan and attend all required check-ups.

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I have cancer that has spread to my brain or its coverings.

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I do not have any ongoing serious illnesses that are not under control.

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I have had bleeding from my esophagus or stomach in the last year.

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I am taking medication to suppress my immune system due to an autoimmune condition.

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I haven't had a stroke, heart attack, or deep vein clot in the last 6 months.

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I have seizures due to a brain condition and need medication.

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I have had a transplant of an organ or bone marrow.

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I am HIV positive.

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I have symptoms of low thyroid hormone levels and am not taking medication for it.

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My blood pressure is not controlled despite taking medication.

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I haven't had serious lung bleeding or any other severe bleeding in the last 6 months.

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I have received treatment for liver cancer before.

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

Maximum tolerated dose (MTD) (Part 1)

Overall response rate (ORR) (Part 2)

Secondary study objectives

Median Duration of response (DOR)

Objective response rate (ORR)

Overall survival (OS)

+7 more

Side effects data

From 2020 Phase 2 trial • 40 Patients • NCT01900002

12%

AST increase

12%

Hypertension

Hyponatremia

Fatigue

ALT increase

Vomiting

Nausea

Dizziness

Diarrhea

Hypophosphatemia

Mucositis

Encephalopathy

Weight Loss

Hypertenstion

Duodenal Ulcer

Sepsis

Acute Renal Failure

Hypotension

Hematuria

Hepatic Hemorrhage

Urinary Retention

Dyspnea

Weakness

Abdominal Pain

Rectal Bleed

Palmar-Planta Erythrodysesthesia

Thrombocytopenia

Hyperbilirubinemia

Proteinuria

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Sorafenib Tosylate, TheraSphere)

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: Part 2: Child Pugh B Expansion (sorafenib, nivolumab)Experimental Treatment2 Interventions

Participants receive sorafenib on days 1-28, and nivolumab IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Part 1: Dose EscalationExperimental Treatment2 Interventions

Participants receive sorafenib PO on days 1-28, and nivolumab IV over 30 minutes beginning on day 15 of course 1, then on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Course will continue until 1 dose-limiting toxicity occurs to establish maximum tolerated dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Sorafenib

2014

Completed Phase 3

~2320