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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) (Part 1)
Overall response rate (ORR) (Part 2)
Secondary outcome measures
Median Duration of response (DOR)
Objective response rate (ORR)
Overall survival (OS)
+7 moreSide effects data
From 2020 Phase 2 trial • 40 Patients • NCT0190000212%
AST increase
12%
Hypertension
9%
Hyponatremia
9%
Fatigue
6%
Vomiting
6%
Nausea
6%
Dizziness
6%
Diarrhea
6%
ALT increase
3%
Weight Loss
3%
Hypertenstion
3%
Duodenal Ulcer
3%
Sepsis
3%
Acute Renal Failure
3%
Hypotension
3%
Hypophosphatemia
3%
Hematuria
3%
Hepatic Hemorrhage
3%
Urinary Retention
3%
Dyspnea
3%
Weakness
3%
Abdominal Pain
3%
Rectal Bleed
3%
Palmar-Planta Erythrodysesthesia
3%
Thrombocytopenia
3%
Hyperbilirubinemia
3%
Proteinuria
3%
Mucositis
3%
Encephalopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Sorafenib Tosylate, TheraSphere)
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
2014
Completed Phase 3
~4750
Sorafenib
2014
Completed Phase 3
~1670
Find a Location
Who is running the clinical trial?
Robin Kate KelleyLead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled
BayerIndustry Sponsor
2,247 Previous Clinical Trials
25,333,569 Total Patients Enrolled
17 Trials studying Hepatocellular Carcinoma
2,769 Patients Enrolled for Hepatocellular Carcinoma
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,816 Total Patients Enrolled
23 Trials studying Hepatocellular Carcinoma
7,582 Patients Enrolled for Hepatocellular Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can be diagnosed using medical imaging if you meet specific criteria set by the American Association for the Study of Liver Diseases.I had minor surgery or a biopsy at least a week ago and have mostly recovered.I had palliative radiation at least 2 weeks ago and have mostly recovered.I agree to use two forms of birth control for 5 months after my last dose, and my male partner agrees to do the same for 7 months.My cancer is a specific type called fibrolamellar or mixed HCC-cholangiocarcinoma.I have had brain symptoms from liver disease needing medication or hospitalization in the last 6 months.I have both hepatitis B and either hepatitis D or C.My cancer has spread to the lungs and shows central or necrotic features.I need medication to prevent blood clots.I am not pregnant or breastfeeding.It's been over 6 weeks since my major surgery and I've mostly recovered.My liver cancer cannot be removed by surgery or cured with other treatments.I have a tumor that can be measured on scans and hasn't been treated with specific local procedures.My organs and bone marrow are functioning well.I only use steroids for adrenal issues, short asthma attacks, or as premeds for contrast dye.I have cancer that has spread to my brain or its coverings.I do not have any ongoing serious illnesses that are not under control.You have a known or suspected allergy or sensitivity to any of the drugs or ingredients used in this study.My liver cancer cannot be removed or cured with surgery or other treatments.It's been over 4 weeks since my last local cancer treatment and I've mostly recovered.I am 18 years old or older.My liver functions are within the required range for the study.I do not have serious heart conditions like recent heart attacks or severe heart failure.I have at least one cancer spot that can be measured and hasn't been treated locally.I have no other cancers except possibly some treated skin, prostate, bladder cancers, or cervical cancer in-situ.It's been over 4 weeks since my last local cancer treatment and I've mostly recovered.I can follow the study plan and attend all required check-ups.I am taking medication to suppress my immune system due to an autoimmune condition.I have signed the consent form for this study.I needed a procedure to remove excess belly fluid in the last 6 months.I have had bleeding from my esophagus or stomach in the last year.The research team needs a sample of your tumor tissue from a previous biopsy or surgery for further testing.My blood tests show enough neutrophils, platelets, and hemoglobin.I haven't had a stroke, heart attack, or deep vein clot in the last 6 months.I have cirrhosis or varices and have undergone the recommended endoscopy treatments.My blood pressure is 140/90 or lower, with or without medication.My liver function is moderately impaired.I am on antiviral therapy for HBV with a viral load under 500 IU/mL.I had palliative radiation at least 2 weeks ago and have recovered with minimal side effects.I haven't taken strong CYP3A4 inducers in the last 28 days.I have seizures due to a brain condition and need medication.If you have not received a tissue or cell diagnosis, you may still be eligible if your radiographic results meet the American Association for the Study of Liver Diseases criteria for diagnosis.I am fully active or restricted in physically strenuous activity but can do light work.I have available tumor tissue from before any treatment.I have had a transplant of an organ or bone marrow.I am HIV positive.I am a woman who can have children and have a negative pregnancy test from the last 28 days.I am fully active or restricted in physically strenuous activity but can do light work.I am 18 years old or older.It's been over 6 weeks since my major surgery and I've mostly recovered.I can swallow and keep down pills.I have symptoms of low thyroid hormone levels and am not taking medication for it.My blood pressure is not controlled despite taking medication.I haven't had serious lung bleeding or any other severe bleeding in the last 6 months.I have received treatment for liver cancer before.I have not had any non-healing wounds or bone fractures in the last 30 days.The investigator thinks that you are not suitable to participate in the trial because of a health condition.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Dose Escalation
- Group 2: Part 2: Child Pugh B Expansion (sorafenib, nivolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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