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Study Comparing Ivonescimab to FOLFOX Drug Combination for Patients with Advanced Biliary Tract Cancer

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer known as advanced biliary tract cancer, which affects the bile ducts and gallbladder. The trial is comparing a new treatment called ivonescimab, also known by its code name AK112 / SMT112, with a standard chemotherapy regimen called FOLFOX. FOLFOX is a combination of three drugs: oxaliplatin, fluorouracil, and calcium folinate. The purpose of the study is to determine if ivonescimab is more effective than FOLFOX in treating this type of cancer.

Participants in the study will receive either ivonescimab or FOLFOX as a second-line treatment, which means it is given after the first treatment has not been successful. Ivonescimab is a special type of medication called a PD-1/VEGF bispecific antibody, which is designed to help the immune system fight cancer and block the growth of new blood vessels that tumors need to grow. The study will monitor how long patients live without their cancer getting worse, which is known as progression-free survival.

The trial will also look at other important outcomes, such as overall survival, which measures how long patients live after starting the treatment, and the disease control rate, which checks how well the cancer is managed with the treatment. Additionally, the study will assess the quality of life of participants using specific questionnaires. The trial is expected to run until 2030, with recruitment starting in 2025. Participants will be closely monitored throughout the study to ensure their safety and to gather information on the effectiveness of the treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive ivonescimab, and the other will receive a combination of drugs known as FOLFOX.
Step 2
Treatment administration
If assigned to the ivonescimab group, you will receive this medication through an injection into a vein. The frequency and dosage will be determined by the study protocol.
If assigned to the FOLFOX group, you will receive a combination of drugs: calcium levofolinate, oxaliplatin, fluorouracil, and calcium folinate. These will also be administered through injections into a vein, with specific dosages and schedules as outlined in the study protocol.
Step 3
Monitoring and assessments
Throughout the trial, regular visits will be scheduled to monitor your health and the effects of the treatment. This will include laboratory tests and other assessments as required by the study.
Step 4
Progress evaluation
Your response to the treatment will be evaluated periodically. This includes assessing the progression of the disease and any side effects experienced.
Step 5
Completion of treatment
The treatment phase will continue until the study's end date or until it is determined that the treatment is no longer beneficial. The estimated end date for the trial is March 30, 2030.
Step 6
Follow-up
After completing the treatment phase, follow-up visits may be scheduled to continue monitoring your health and gather additional data for the study.

Who can join the trial?

23 criteria

Sign a written informed consent form before any trial-specific procedures. If unable to write, a trusted person can confirm consent in writing.
Have proper biliary drainage with no ongoing infection.
Women who can have children and men with partners who can have children must use effective birth control during the trial and for a specified time after. Men must not donate sperm, and women must not donate eggs during this time.
Have a confirmed diagnosis of certain types of bile duct cancer or gallbladder cancer, but not ampullary carcinoma.
Women who can have children must have a negative pregnancy test before starting the trial and on the day of the first dose.
Be willing and able to follow the study protocol, including attending visits, following the treatment plan, and undergoing tests and procedures.
Have social security or private health insurance as required by local regulations for clinical trial participation.
Have locally advanced (not removable by surgery) or metastatic disease.
Have participated in the Screening phase of the SAFIR-ABC10 trial.
Have experienced disease progression after standard first-line treatment, as assessed by the investigator.
Be eligible for second-line treatment with FOLFOX, a type of chemotherapy.
Have adequate bone marrow function, which means having certain levels of blood cells and hemoglobin without recent blood transfusions or growth factor therapy.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, indicating the ability to carry out daily activities.
Have at least one lesion that can be measured according to specific criteria (RECIST v1.1).
Be at least 18 years old.
Have normal levels of potassium, magnesium, and calcium in the blood.
Have adequate liver function, with specific levels of bilirubin and liver enzymes.
Have adequate kidney function, with certain levels of creatinine clearance or glomerular filtration rate and low urine protein levels.
Have normal blood clotting function, with specific levels of prothrombin time and partial thromboplastin time.
Have adequate heart function, with a left ventricular ejection fraction of at least 50% as determined by a heart scan.
Have documented hepatitis status, with specific requirements for those with hepatitis B or C.
Have had an esophagogastroduodenoscopy (a type of endoscopy) within 6 months and treatment of any varices (enlarged veins) as needed before starting the trial.
Have resolved any bile duct obstruction.

Who cannot join the trial?

7 criteria

Patients who have a different type of cancer other than advanced biliary tract cancer (BTC) cannot participate. Biliary tract cancer is a type of cancer that affects the bile ducts.
Patients who are not in the age range specified for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have participated in another clinical trial recently may not be eligible to join this study.
Patients who have certain medical conditions that could interfere with the study results or pose a risk to their health cannot participate.
Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate, cannot join the study.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
CHU Grenoble Alpes
Verified
La Tronche, France

Trial locations

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Investigated drugs

Ivonescimab
is a new type of medication being tested in this trial. It is a bispecific antibody that targets both PD-1 and VEGF. This means it is designed to help the immune system fight cancer cells while also blocking the growth of new blood vessels that tumors need to grow. The trial is testing whether ivonescimab is more effective than standard chemotherapy for treating advanced biliary tract cancers.
FOLFOX
is a combination of chemotherapy drugs used as a standard treatment for certain types of cancer, including biliary tract cancers. It includes a mix of medications that work together to stop cancer cells from growing and dividing. In this trial, FOLFOX is being used as a comparison to see if ivonescimab offers better results for patients.

What is already known about the treatment

Ivonescimab – Ivonescimab is administered intravenously and is currently being studied in clinical trials as a potential treatment for advanced biliary tract cancer. It is a bispecific antibody that targets both PD-1 and VEGF, aiming to enhance the immune system's ability to fight cancer while also inhibiting blood vessel growth that tumors need to thrive. This medication is classified as an immunotherapy agent and is being compared to standard chemotherapy to assess its effectiveness in improving progression-free survival in patients.

Investigated diseases

Advanced Biliary Tract Cancer – This is a type of cancer that occurs in the bile ducts, which are the channels that carry bile from the liver and gallbladder to the small intestine. It is considered advanced when it has spread beyond its original location to nearby tissues or other parts of the body. The disease often progresses with symptoms such as jaundice, abdominal pain, and weight loss. As the cancer advances, it may cause blockages in the bile ducts, leading to further complications. The progression of the disease can vary, but it typically involves the growth and spread of cancerous cells, affecting liver function and overall health.