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Study on the Safety and Effectiveness of Domvanalimab and Zimberelimab for Adults with Advanced Rare Cancers Resistant to Standard Treatment

Verified siteRegistered drugNo placebo
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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 the effects of a new treatment combination for patients with advanced forms of five rare cancers. These cancers include peritoneal mesotheliomas, gestational trophoblastic tumors, B3 thymomas and thymic carcinomas, anaplastic thyroid carcinomas, and gastroenteropancreatic neuroendocrine tumors (GEP-NET) and carcinoid tumors. The treatment being tested is a combination of two medications: Domvanalimab and Zimberelimab. Domvanalimab is also known by its code name AB154, and Zimberelimab is referred to as AB122. These medications are designed to work together to help the immune system fight cancer more effectively.

The purpose of the study is to evaluate how well this combination treatment works in patients whose cancers have progressed or become resistant after at least one standard treatment. The study will involve patients receiving the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of up to 24 weeks, during which the effectiveness and safety of the treatment will be closely monitored. Patients will be grouped into different cohorts based on their specific type of cancer, and the study will assess various outcomes, such as the rate of cancer progression and overall survival.

Throughout the study, researchers will collect data to understand how the treatment affects the different types of rare cancers. The goal is to determine if the combination of Domvanalimab and Zimberelimab can provide a new and effective treatment option for patients with these challenging conditions. The study is part of a larger effort to explore innovative therapies for rare cancers, which often have limited treatment options. By participating in this trial, researchers hope to gather valuable information that could lead to improved care for patients with these rare and advanced cancers.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and previous treatments.

    A physical examination and necessary laboratory tests will be performed to ensure all health criteria are met.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of the study medications. These include domvanalimab and zimberelimab, both given through an intravenous (IV) infusion.

    The frequency and dosage of these medications will be determined by the study protocol and the healthcare team.

  3. Step 3

    Ongoing treatment and monitoring

    Regular visits to the study site will be required for continued administration of the medications and monitoring of health status.

    During these visits, additional tests and assessments will be conducted to track the progress and any side effects.

  4. Step 4

    Evaluation of treatment response

    After 24 weeks, an evaluation will be conducted to assess the response to the treatment. This includes imaging tests and other assessments as needed.

    The primary goal is to determine the effectiveness of the treatment in managing the cancer.

  5. Step 5

    Follow-up

    After the treatment phase, follow-up visits will be scheduled to monitor long-term health and any delayed effects of the treatment.

    These visits will help ensure ongoing health and address any concerns that may arise.

Who can join the trial?

13 criteria

  • Patients must have one of the following five rare cancers: peritoneal mesotheliomas, gestational trophoblastic tumors, B3 thymomas and thymic carcinomas, anaplastic thyroid carcinomas, or GEP-NET & carcinoid tumors.
  • The cancer must be advanced or metastatic, meaning it has spread to other parts of the body, and must have shown progression or resistance after at least one previous standard treatment.
  • Patients must be at least 18 years old.
  • Patients must have a life expectancy of at least 16 weeks.
  • Patients must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures the ability to perform daily activities.
  • Patients must be willing to provide a sample of their tumor tissue, either from a previous biopsy or a new one, unless medically contraindicated.
  • Patients must have adequate bone marrow function, which includes specific levels of white blood cells, platelets, and hemoglobin.
  • Patients must have adequate kidney function, measured by a creatinine clearance of at least 30 ml/min.
  • Patients must have specific liver function levels, including serum bilirubin and liver enzymes (AST/ALT).
  • Patients must agree to use highly effective contraception if they are men or women of childbearing age.
  • Patients must sign an informed consent form before participating in any study-related procedures.
  • Patients must be able to comply with the study protocol, including attending follow-up visits and examinations.
  • Patients must be affiliated with the French social security system.

Who cannot join the trial?

5 criteria

  • Patients who do not have one of the following rare cancers: peritoneal mesotheliomas, gestational trophoblastic tumors, B3 thymomas and thymic carcinomas, anaplastic thyroid carcinomas, or GEP-NET & carcinoid tumors.
  • Patients whose cancer is not advanced or metastatic. (Advanced cancer means it has spread to other parts of the body. Metastatic means the cancer has spread from where it started to other parts of the body.)
  • Patients whose cancer is not progressive or resistant after at least one previous line of standard treatment. (Progressive means the cancer is getting worse. Resistant means the cancer is not responding to treatment.)
  • Patients who are not adults. (This means the study is only for people who are 18 years or older.)
  • Patients who are part of a vulnerable population. (Vulnerable populations include groups like children, pregnant women, or people who cannot make decisions for themselves.)
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Investigated drugs

  • Domvanalimab

    is a type of medication known as an antibody. It works by helping the body's immune system recognize and attack cancer cells. In this trial, Domvanalimab is being used to treat patients with certain types of rare cancers that have not responded well to other treatments. By blocking specific proteins that help cancer cells hide from the immune system, Domvanalimab aims to enhance the body's natural ability to fight cancer.

  • Zimberelimab

    is another antibody medication used in this trial. It is designed to boost the immune system's response against cancer cells. Zimberelimab works by targeting and blocking a protein that usually helps cancer cells evade the immune system. By doing so, it helps the immune system to better detect and destroy cancer cells. This medication is being tested in combination with Domvanalimab to see if they work better together in treating rare cancers that have not improved with standard treatments.

What is already known about the treatment

  • Domvanalimab

    Domvanalimab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials and is not yet widely available in standard medical practice. The main therapeutic use of Domvanalimab is for treating certain rare and advanced cancers, specifically peritoneal mesotheliomas, gestational trophoblastic tumors, B3 thymomas and thymic carcinomas, anaplastic thyroid carcinomas, and GEP-NET & carcinoid tumors. At the molecular level, Domvanalimab works by blocking specific proteins that help cancer cells evade the immune system, allowing the body's natural defenses to better target and destroy cancer cells. It is classified as an immunotherapy drug, which means it helps the immune system fight cancer.

  • Zimberelimab

    Zimberelimab is also administered via intravenous infusion, allowing it to enter the bloodstream directly. Like Domvanalimab, it is under investigation in clinical trials and is not yet part of standard medical treatments. Zimberelimab is used to treat the same rare and advanced cancers as Domvanalimab, including peritoneal mesotheliomas, gestational trophoblastic tumors, B3 thymomas and thymic carcinomas, anaplastic thyroid carcinomas, and GEP-NET & carcinoid tumors. Its mechanism of action involves inhibiting proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's ability to fight the cancer. Zimberelimab is also classified as an immunotherapy drug, focusing on boosting the immune response against cancer.

Investigated diseases

  • Peritoneal Mesothelioma

    Peritoneal mesothelioma is a rare cancer that occurs in the lining of the abdomen, known as the peritoneum. It typically begins with the formation of small nodules on the peritoneal surface, which can grow and merge into larger masses. As the disease progresses, it can cause abdominal pain, swelling, and digestive issues due to the accumulation of fluid and tumor growth. The cancer cells can spread to nearby organs and tissues, leading to further complications. Over time, the disease can become more aggressive, affecting the patient's overall health and quality of life.

  • Gestational Trophoblastic Tumor

    Gestational trophoblastic tumor is a group of rare tumors that involve abnormal growth of cells inside a woman's uterus. These tumors originate from the tissue that forms after conception, specifically the trophoblast cells that normally develop into the placenta. The disease can progress from benign forms, like hydatidiform mole, to malignant forms, such as choriocarcinoma. As it advances, it can invade the uterine wall and spread to other parts of the body, including the lungs and brain. Symptoms may include abnormal vaginal bleeding, pelvic pain, and an enlarged uterus.

  • B3 Thymoma and Thymic Carcinoma

    B3 thymoma and thymic carcinoma are types of tumors that originate in the thymus gland, located in the chest. B3 thymoma is characterized by a mixture of lymphocytes and epithelial cells, while thymic carcinoma is more aggressive and resembles other types of cancer. As these tumors grow, they can cause symptoms such as chest pain, cough, and difficulty breathing due to pressure on nearby structures. The disease can spread to surrounding tissues and organs, including the lungs and lymph nodes. Over time, the tumors may become more invasive, affecting the patient's respiratory function and overall health.

  • Anaplastic Thyroid Carcinoma

    Anaplastic thyroid carcinoma is a rare and aggressive form of thyroid cancer. It typically presents as a rapidly growing mass in the neck, which can cause symptoms such as difficulty swallowing, hoarseness, and shortness of breath. The cancer cells can invade nearby tissues and spread to distant parts of the body, including the lungs and bones. As the disease progresses, it can lead to significant changes in the neck's appearance and function. The rapid growth and spread of the tumor can severely impact the patient's quality of life.

  • Gastroenteropancreatic Neuroendocrine Tumor and Carcinoid Tumor

    Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and carcinoid tumors are rare cancers that arise from neuroendocrine cells in the gastrointestinal tract and pancreas. These tumors can produce hormones that cause various symptoms, such as flushing, diarrhea, and abdominal pain. As they grow, they can obstruct the digestive tract and spread to the liver and other organs. The disease progression can vary, with some tumors growing slowly and others more rapidly. Over time, the tumors can lead to significant digestive and systemic issues, affecting the patient's overall well-being.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517254-99-00Protocol code69HCL24_0656Estimated enrolment186 patientsSponsorHospices Civils De Lyon

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