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A study to evaluate the safety and effectiveness of PF-08634404 and ipilimumab in adults with advanced or spreading liver cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with Hepatocellular Carcinoma, which is a type of primary liver cancer that cannot be removed through surgery and has either spread to nearby areas or to other parts of the body. The purpose of the study is to evaluate the safety and effectiveness of a new medicine called PF-08634404. This investigation will look at how the drug works when used by itself and when used in combination with another medication called ipilimumab.

Participants will receive the medications through intravenous infusion, which means the medicine is delivered directly into a vein. During the study, researchers will monitor how the body processes the drugs and observe any side effects to ensure the treatment is safe. The study will also aim to find the most appropriate dose of PF-08634404 when it is used alongside ipilimumab to best help fight the cancer.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Phase 1b (safety run-in)
The safety run-in stage is performed to evaluate how well the body tolerates the study medications.
The study medications, pf-08634404 (a concentrate for infusion) and ipilimumab (known as yervoy, a solution for infusion), are administered through an intravenous line, which means they are delivered directly into a vein.
During this stage, the medications are given in combination.
Step 2
Phase 2 (dose optimization and expansion)
The dose optimization and expansion stage is performed to find the most effective dose of the medicine and to see how well it works against the cancer.
The pf-08634404 medication may be given alone as a monotherapy or in combination with ipilimumab.
The safety, tolerability, and effectiveness of these treatments are monitored closely throughout this stage.

Who can join the trial?

15 criteria

You must be at least 18 years old or the legal age required to agree to medical studies in your area.
You must have locally advanced or metastatic hepatocellular carcinoma, which is a type of liver cancer that has either grown into nearby tissues or spread to other parts of the body.
Your diagnosis must be confirmed through histology or cytology, which means looking at your cells under a microscope to confirm the cancer, or through specific medical guidelines if you have cirrhosis (scarring of the liver).
Your cancer cannot be treated with surgery or locoregional therapies (treatments that target a specific area of the body, like the liver), or your cancer has continued to grow after those treatments.
If you had locoregional therapy, at least 28 days must have passed since the treatment ended before your first scan for this study.
You must have at least one measurable lesion, which is a tumor or area of cancer growth that doctors can clearly see and measure using standard medical rules.
You must have enough tumor tissue available, such as a tissue sample from a biopsy, to allow researchers to study the cancer cells.
You must not have received any systemic therapy (treatment that travels through the entire bloodstream, such as chemotherapy) for your liver cancer before.
Your ECOG Performance Status must be 0 or 1, which means you are generally able to carry out normal daily activities and are mostly mobile.
Your liver function must be evaluated using the Child-Pugh Class, a scoring system used to measure how well your liver is still working.
You must have adequate organ function, meaning your blood and organs are working well enough to safely participate.
Your blood counts must be stable without the recent use of transfusions (receiving blood or blood components) or growth factors (medicines that help the body make more blood cells) within the last 7 days.
If you have HCV (Hepatitis C virus), it must be managed according to your hospital's standard care.
If you have HBV (Hepatitis B virus), you must be taking antiviral therapy (medicine to fight the virus) and your viral load (the amount of virus in your blood) must be at a very low, controlled level before starting.
You must provide written informed consent, which means you have read the study details and signed a document agreeing to participate.

Who cannot join the trial?

37 criteria

People with any medical or mental health conditions, such as thoughts of self-harm within the last year or actions related to self-harm within the last 5 years.
People with laboratory abnormalities (unusual results from blood or urine tests) that might make participating in the study unsafe.
People with serious heart problems within the last 6 months, such as unstable angina (chest pain that occurs unpredictably), myocardial infarction (a heart attack), or arrhythmia (an irregular heartbeat).
People with conduction system abnormalities, which are problems with the electrical signals that tell the heart when to beat.
People who have had coronary or peripheral artery bypass grafts (surgery to create new paths for blood flow).
People who have experienced a transient ischemic attack (a temporary period of symptoms similar to a stroke), a cerebrovascular accident (a stroke), or a cerebral hemorrhage (bleeding in the brain).
People with congestive heart failure (a condition where the heart does not pump blood well enough) or decompensated liver cirrhosis (advanced scarring of the liver that is no longer being managed by the body).
People with nephrotic syndrome (a kidney disorder that causes the body to pass too much protein in the urine).
People with uncontrolled diabetes, which is defined by high blood sugar levels or high HbA1c (a measure of average blood sugar over three months) accompanied by symptoms like excessive thirst or urination.
People with uncontrolled hypertension (consistently high blood pressure).
People who have had thromboembolic events, which are blood clots that travel through the bloodstream, such as in the arteries or veins.
People with an abnormal QTcF interval, which is a measurement of the time it takes for the heart muscle to recharge between beats, as seen on an ECG (a test that records the electrical activity of the heart).
People who have had major surgery or severe injury within the last 4 weeks, or anyone planning major surgery during the study.
People who have had minor surgery within the last 3 days.
People with a history of severe bleeding tendencies, such as gastrointestinal bleeding (bleeding in the stomach or intestines), hemoptysis (coughing up blood), or epistaxis (nosebleeds).
People with a history of severe ulcers, perforation (a hole made in the wall of an organ), or obstruction (a blockage) in the digestive tract within the last 6 months.
People with active infections, such as those caused by viruses, bacteria, or fungi, or people currently taking antimicrobial treatment (medicine used to kill germs).
People with HIV, unless the infection is well-controlled with a stable medicine routine.
People with active tuberculosis (a serious bacterial infection that usually affects the lungs).
People with a history of primary immunodeficiency (a condition where the immune system is missing parts or doesn't work correctly).
People with a severe allergy to the study medicine or to antibodies (proteins used by the immune system).
People who have previously used anti-VEGF inhibitors or immunotherapy (treatments that help the immune system fight cancer).
People who had radiotherapy (using radiation to treat cancer) in a part of the body other than the liver within 2 weeks of starting the study.
People using anticoagulants (blood thinners) or antiplatelet therapy (medicines that prevent blood cells from sticking together) within 10 days of the first dose.
People who have received a live vaccine within the last 4 weeks.
People using high doses of corticosteroids (steroids that reduce inflammation) or other immunosuppressants (medicines that lower the body's immune response).
People with ascites (a buildup of fluid in the abdomen) or hepatic encephalopathy (brain problems caused by liver disease).
People with active lesions (areas of abnormal tissue) in the central nervous system, which includes the brain and spinal cord.
People at high risk of hemorrhage (severe bleeding) or fistula (an abnormal connection between two organs) due to the location of their tumor.
People who have had another type of malignancy (cancer) within the last 3 years, unless it was a very low-risk type.
People with unresolved toxicities (lingering side effects) from previous cancer treatments.
People who have had an allogeneic organ transplant or a stem cell transplant.
People with active autoimmune diseases (conditions where the immune system attacks the body) that require systemic treatment.
People with interstitial lung disease (ILD) or pneumonitis (inflammation of the lung tissue).
People who have received a different investigational product (an experimental drug or vaccine) within the last 30 days.
People who are breastfeeding, or those who are unwilling to follow strict pregnancy prevention measures.
Staff members working on the study and their immediate family members.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Unita Sanitaria Locale Di Bologna
Verified
Bologna, Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Verified
Mainz, Germany
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

PF-08634404
is an experimental drug being tested to see how well it works on its own and when used together with another treatment to fight liver cancer.
Ipilimumab
is an immunotherapy medication that helps the body's own immune system recognize and attack cancer cells.

Ipilimumab

What is already known about the treatment

PF-08634404
This experimental medication is provided as a concentrated liquid that is administered directly into a vein through an infusion. Currently being studied in clinical trials, it is being tested for its ability to treat advanced liver cancer. It works by targeting specific molecules within the body to help stop the growth of cancer cells. This substance is classified as an investigational anti-cancer agent.
Ipilimumab
This medication is a solution administered into a vein through an infusion to treat certain types of advanced cancers. It is an established treatment known to help the body's own immune system recognize and attack cancer cells by blocking a specific protein that normally stops immune responses. Because of this action, it is categorized as an immunotherapy drug.

Investigated diseases

Hepatocellular carcinoma - This is a type of cancer that starts in the main cells of the liver. It often develops from chronic liver damage or scarring. The disease can progress from a localized state where it remains in one area of the liver to a more advanced stage. In advanced stages, the cancer may spread to nearby blood vessels or move to distant organs throughout the body.