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Study on PET Imaging with Fianlimab and Cemiplimab for Patients with Advanced Solid Tumors, with or without Platinum-Based Chemotherapy

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 advanced forms of solid cancer, which can include types like melanoma, non-small-cell lung cancer (NSCLC), cervical cancer, and others. The study involves a new treatment approach using a medication called Fianlimab (also known by its code name REGN3767) and another medication called Cemiplimab. Fianlimab is a type of protein designed to target specific parts of cancer cells, and Cemiplimab is used to help the immune system fight cancer. Some patients may also receive platinum-based chemotherapy, which is a common cancer treatment that uses drugs containing the metal platinum to kill cancer cells.

The purpose of this study is to find the best dose of Fianlimab and the best time to perform a special type of imaging called PET scan to see how the treatment is working. A PET scan is a test that helps doctors see how organs and tissues inside the body are functioning. The study will also look at how safe Fianlimab is for patients. Participants will receive the treatment and undergo PET scans before and during their treatment with Cemiplimab, with or without chemotherapy. The study will help researchers understand how the treatment affects the body and how well it works against the cancer.

Throughout the study, patients will be monitored closely to ensure their safety and to observe any changes in their condition. The study aims to provide valuable information that could lead to better treatment options for people with advanced solid cancers. By understanding how these medications work together, researchers hope to improve outcomes for patients facing these challenging diseases.

The research process

The trial runs in 6 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 is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests and imaging scans are performed to establish baseline health status and to identify measurable disease.

  2. Step 2

    Imaging preparation

    Preparation for ImmunoPET imaging involves the administration of a tracer called 89Zr-DFO-REGN3767. This tracer helps visualize certain proteins in the body using PET scans.

    The optimal dose and timing for imaging are determined during this phase.

  3. Step 3

    Treatment initiation

    Treatment begins with the administration of cemiplimab, a medication given through an intravenous infusion. The dosage is 350 mg, and it is administered every three weeks.

    In some cases, cemiplimab may be combined with platinum-based chemotherapy, depending on the specific cancer type and treatment plan.

  4. Step 4

    Ongoing imaging and monitoring

    Regular PET scans are conducted to monitor the uptake of the tracer in tumor lesions. This helps assess the response to treatment.

    Standardized uptake values (SUV) are measured to evaluate the distribution and effectiveness of the tracer.

  5. Step 5

    Safety and efficacy evaluation

    Throughout the trial, safety is monitored by tracking any adverse events and changes in laboratory test results.

    The effectiveness of the treatment is evaluated by comparing tumor response to cemiplimab, with or without chemotherapy, using established criteria.

  6. Step 6

    Completion and follow-up

    Upon completion of the treatment cycles, a final assessment is conducted to evaluate overall health and treatment outcomes.

    Follow-up visits may be scheduled to monitor long-term effects and gather additional data.

Who can join the trial?

17 criteria

  • Must be at least 18 years old at the time of signing the consent form.
  • Must have a confirmed diagnosis of locally advanced or **metastatic solid cancer**. This means the cancer has spread from its original site to other parts of the body.
  • Must have at least one lesion (a damaged or abnormal area of tissue) that can be accessed and is suitable for a biopsy, which is a procedure to remove a small sample of tissue for testing.
  • Must have **measurable disease**, meaning the cancer can be measured in size using standard methods. Lesions that have been treated with radiation should not be counted unless they have grown after treatment.
  • Must have an **ECOG performance status** of 0 or 1. This is a scale used to assess how a patient's disease is affecting their daily living abilities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate organ and bone marrow function, which includes:
    • Hemoglobin level of at least 9.0 g/dL (a measure of red blood cells).
    • Absolute neutrophil count of at least 1.5 x 109/L (a type of white blood cell).
    • Absolute lymphocyte count of at least 0.75 x 109/L (another type of white blood cell).
    • Platelet count of at least 100 x 109/L (cells that help with blood clotting).
    • Serum creatinine level of no more than 1.5 times the upper limit of normal, or an estimated glomerular filtration rate greater than 30 mL/min/1.73 m2 (measures of kidney function).
    • Adequate liver function, which includes:
      • Total bilirubin level of no more than 1.5 times the upper limit of normal (or 3 times if the liver is involved with cancer). Bilirubin is a substance made during the normal breakdown of red blood cells.
      • Aspartate aminotransferase (AST) level of no more than 2.5 times the upper limit of normal (or 5 times if the liver is involved with cancer). AST is an enzyme found in the liver.
      • Alanine aminotransferase (ALT) level of no more than 2.5 times the upper limit of normal (or 5 times if the liver is involved with cancer). ALT is another enzyme found in the liver.
      • Alkaline phosphatase (ALP) level of no more than 2.5 times the upper limit of normal (or 5 times if the liver or bones are involved with cancer). ALP is an enzyme related to the liver and bones.
      • Must sign an informed consent form, which means they agree to participate in the study after being informed of all the details.
      • Must be willing and able to follow all the procedures required by the study.

Who cannot join the trial?

3 criteria

  • Patients who have a type of cancer that has spread to other parts of the body, known as metastatic solid tumors, cannot participate. This includes cancers like melanoma, lung cancer, cervical cancer, and others.
  • Patients who are not able to benefit from the specific treatment being studied, which involves a drug called cemiplimab and possibly chemotherapy, are excluded.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, are not allowed to join the study.
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Investigated drugs

  • Cemiplimab

    is a medication used in this trial to treat patients with advanced solid cancers. It works by helping the immune system recognize and attack cancer cells more effectively. This medication is often used in combination with other treatments to enhance its effectiveness.

  • Platinum-based chemotherapy

    refers to a group of cancer treatments that include drugs containing the metal platinum. These medications are used to damage the DNA of cancer cells, which can help stop their growth and spread. In this trial, platinum-based chemotherapy may be used alongside cemiplimab to improve treatment outcomes.

  • 89Zr-DFO-REGN3767

    is an investigational imaging agent used in this trial. It is designed to help visualize certain proteins on cancer cells through PET scans. This imaging helps doctors understand how the cancer is responding to treatment with cemiplimab, with or without platinum-based chemotherapy. The goal is to determine the best dose and timing for using this imaging agent.

What is already known about the treatment

Cemiplimab – Cemiplimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating various metastatic solid tumors, including melanoma and non-small-cell lung carcinoma. It is an approved medication in the field of oncology, with ongoing research to expand its therapeutic applications. The main therapeutic indication for cemiplimab is its use as an immune checkpoint inhibitor, specifically targeting the PD-1 receptor on T-cells to enhance the immune system's ability to fight cancer cells. It belongs to the pharmacological class of monoclonal antibodies, which are designed to block specific proteins involved in cancer cell growth and survival.

Investigated diseases

  • Melanoma

    A type of skin cancer that begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. It can develop in any part of the body that contains melanocytes, including the skin, eyes, and internal organs. Melanoma is known for its ability to spread to other parts of the body if not detected early. It often appears as a new mole or a change in an existing mole, with irregular borders and multiple colors. The progression of melanoma can vary, but it typically involves the growth of cancerous cells beyond the original site.

  • Non-Small Cell Lung Carcinoma (NSCLC)

    A group of lung cancers that behave similarly and are the most common type of lung cancer. NSCLC includes subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It generally grows and spreads more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can spread to other parts of the body, including the lymph nodes and brain.

  • Cervical Cancer

    A type of cancer that occurs in the cells of the cervix, the lower part of the uterus that connects to the vagina. It is often caused by persistent infection with certain types of human papillomavirus (HPV). In its early stages, cervical cancer may not cause noticeable symptoms, but as it progresses, it can lead to abnormal vaginal bleeding, pelvic pain, and pain during intercourse. The disease can spread to nearby tissues and organs if not treated.

  • Microsatellite Instability-High/Deficient Mismatch Repair (MSI-H/dMMR) Cancer

    A condition characterized by genetic hypermutability that results from impaired DNA mismatch repair. This defect can lead to the development of various types of cancer, including colorectal, endometrial, and gastric cancers. MSI-H/dMMR cancers tend to have a high number of mutations, which can affect their growth and spread. These cancers may present with symptoms specific to the organ affected, such as changes in bowel habits for colorectal cancer.

  • Renal Cell Carcinoma (RCC)

    The most common type of kidney cancer in adults, originating in the lining of the small tubes in the kidney. RCC often grows as a single tumor within a kidney, but it can also occur in both kidneys simultaneously. Symptoms may include blood in the urine, a lump in the abdomen, and unexplained weight loss. As RCC progresses, it can spread to other organs, such as the lungs and bones.

  • Cutaneous Squamous Cell Carcinoma (CSCC)

    A common form of skin cancer that arises from the squamous cells in the outer layer of the skin. It typically develops on sun-exposed areas of the body, such as the face, ears, and hands. CSCC may appear as a scaly red patch, open sore, or wart-like growth that may crust or bleed. If left untreated, it can grow larger and invade deeper layers of skin and other tissues.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516795-15-00Protocol code202000570Estimated enrolment38 patientsSponsorUniversitair Medisch Centrum Groningen

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