Exploring magrolimab use for head and neck tumors

Recruting new patients

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    What is this study about?

    This is a study about treatment of patients with squamous cell carcinoma, a type of head and neck cancer. The study will test the safety and effectiveness of a drug called magrolimab, used together with other cancer treatments. The study wants to know how well the treatment works. Throughout the trial, participants’ health will be closely monitored. This includes regular medical check-ups, imaging tests, and other diagnostic procedures to assess how well the cancer is responding to the treatment regimen.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Antwerpen , Belgium

      Brasschaat , Belgium

      Edegem , Belgium

      Leuven , Belgium

      Libramont-Chevigny , Belgium

      Mechelen , Belgium

      Namur , Belgium

      Bordeaux , France

      Dijon , France

      Lyon , France

      Marseille , France

      Nice , France

      Paris , France

      Paris , France

      Pierre-benite , France

      Suresnes , France

      Villejuif , France

      Berlin , Germany

      Bonn , Germany

      Gu00c3ttingen , Germany

      Hamburg , Germany

      Leipzig , Germany

      Munich , Germany

      Bologna , Italy

      Brescia , Italy

      Brescia , Italy

      Lucca , Italy

      Milan , Italy

      Modena , Italy

      Reggio Emilia , Italy

      Siena , Italy

      Bydgoszcz , Poland

      Gliwice , Poland

      Poznan , Poland

      Siedlce , Poland

      Warsaw , Poland

      Braga , Portugal

      Faro , Portugal

      Lisboa , Portugal

      Matosinhos , Portugal

      Porto , Portugal

      Porto , Portugal

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Jaen , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Malaga , Spain

      Pamplona , Spain

      Sevilla , Spain

      Sevilla , Spain

      Valencia , Spain

      Valencia , Spain

      London , United Kingdom

      Taunton , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, here are the steps you would need to follow if you are part of the Safety Run-in Cohort 1 group:

      1. You will receive magrolimab at a dose and schedule to be determined during the trial.
      2. You will be administered pembrolizumab at a dose of 200 mg on Day 1 of each 21-day cycle.
      3. You will be given 5-fluorouracil (5-FU) at a dose of 1000 mg/m²/day from Days 1 to 4 of each cycle, for up to 6 cycles.
      4. You will also receive platinum chemotherapy (either cisplatin at a dose of 100 mg/m² or carboplatin AUC 5, based on the investigator’s choice, for up to 6 cycles).
      5. Treatment will continue until you experience unacceptable toxicity or your disease progresses.
      6. The magrolimab dose level will not be changed after the recommended Phase 2 dose (RP2D) is determined.
      7. Each treatment cycle in this study is 21 days long.

      It is important to follow the protocol as outlined by the trial investigators and communicate any side effects or concerns you have to the study staff.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have a histologically or cytologically confirmed diagnosis of metastatic or locally recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) that is considered incurable by local therapies. Here are the specifications regarding the disease criteria:

      1. Your disease should be metastatic or locally recurrent HNSCC.
      2. The disease must be considered incurable by local therapies.
      3. Eligible primary tumor locations include the oropharynx, oral cavity, hypopharynx, and larynx. However, the nasopharynx is excluded from the eligible locations.
      4. The study does not require a specific PD-L1 status for participation.

      These are based on the inclusion criteria for the trial.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria for the Study:

      1. Histologically or cytologically confirmed metastatic or locally recurrent HNSCC: You must have a diagnosis of head and neck squamous cell carcinoma (HNSCC) that has spread to other parts of the body (metastatic) or has come back in the same area after treatment (locally recurrent) and cannot be cured by local treatments. The diagnosis should be confirmed by looking at cells under a microscope (histology) or by examining the cells’ appearance (cytology).
      2. Prior Systemic Therapy for Cohort 1 and Phase 2 Cohort 1: You should not have received any systemic therapy, which is treatment using substances that travel through the bloodstream to reach cells all over the body, for the recurrent or metastatic cancer.
      3. Primary Tumor Location: The original tumor should be located in the oropharynx (part of the throat behind the mouth), oral cavity (mouth), hypopharynx (lower part of the throat), or larynx (voice box). The nasopharynx (upper part of the throat behind the nose) is not included in the study.
      4. PD-L1 Status: Your cancer’s PD-L1 status, which is a marker that some tumors use to protect themselves from the immune system, is not a factor for eligibility. This means you can participate regardless of PD-L1 status.
      5. Prior Systemic Anticancer Therapy for Cohort 2 and Phase 2 Cohort 3: If you belong to Cohort 2 or Phase 2 Cohort 3, you must have locally advanced/mHNSCC with at least 1 but no more than 2 lines of prior systemic anticancer therapy in the locally advanced/metastatic setting. A “line of therapy” refers to a specific course of drugs given for cancer treatment and may include multiple drugs or combinations.

      Please let me know if you need further explanations or have more questions.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria:

      1. Active central nervous system (CNS) disease: This refers to an active illness affecting the brain or spinal cord. You can’t participate if you have this condition unless you have asymptomatic (no symptoms) and stable treated CNS lesions, and you have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks.
      2. History of (noninfectious) pneumonitis that required steroids or current pneumonitis: Pneumonitis is an inflammation of the lung tissue. If you required steroids to manage pneumonitis or currently have pneumonitis, you cannot participate.
      3. Progressive disease within 6 months of completion of curatively intended treatment for locally advanced/mHNSCC: Locally advanced/mHNSCC refers to head and neck squamous cell carcinoma, a type of cancer. If your disease has worsened within 6 months after completing treatment intended to cure it, you’re excluded from the trial.
      4. Prior treatment with certain checkpoint inhibitors: These are drugs that help to “release the brakes” on the immune system and are used in cancer therapy. Examples include:
        • Anti-programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 checkpoint inhibitors.
        • Anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) checkpoint inhibitors.

        You can’t participate if you have received these treatments before Safety Run-in Cohort 1, Pre-expansion Safety Run-in Cohort for Magrolimab + Pembrolizumab, and Phase 2 Cohorts 1 and 2.

      5. Prior treatment with a taxane: Taxanes are a class of chemotherapy drugs. If you have received a taxane before Safety Run-in Cohort 2 and Phase 2 Cohort 3, you are not eligible for the study.

      Note: There may be other protocol-defined inclusion/exclusion criteria that could apply to your situation.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study along with a brief description of their active substances are:

      1. Magrolimab (Anti-CD47 Antibody): This is a monoclonal antibody that binds to CD47, a protein overexpressed on the surface of cancer cells which signals to the immune system not to eat (phagocytose) them. Magrolimab blocks this signal, allowing the immune system to target and destroy the cancer cells.
      2. Pembrolizumab (Keytruda): An immune checkpoint inhibitor, specifically a PD-1 blocking antibody, used in cancer immunotherapy. This drug helps the immune system to prevent the cancer cells from hiding and enables it to detect and fight cancer cells.
      3. Docetaxel (Taxotere): A chemotherapy medication used to treat several kinds of cancer. It works by interfering with the division of cancer cells, slowing or stopping their growth and multiplication.
      4. 5-FU (5-Fluorouracil): This is a type of chemotherapy used to treat cancer. It is an antimetabolite, meaning it interferes with the synthesis and function of DNA and RNA, which are necessary for cancer cells to grow and survive.
      5. Cisplatin: A platinum-containing chemotherapy drug used to treat various types of cancers. It works by causing DNA damage which ultimately leads to apoptosis (cell death) of cancer cells.
      6. Carboplatin: Similar to cisplatin, carboplatin is also a chemotherapy medication containing platinum. It is used to treat various forms of cancer by causing DNA damage and inhibiting DNA synthesis in cancer cells.
      7. Zimberelimab (Anti-PD-1 Antibody): An investigational humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor, which is designed to block the PD-1/PD-L1 pathway, enhancing the body’s immune response to cancer.

      All these drugs are administered intravenously as part of the treatment regimen for participants in the clinical trial.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances participating in the clinical trial are as follows:

      1. Magrolimab: This substance is known to medicine and medical literature. It is administered intravenously and is used in various cohorts of the clinical trial in combination with other drugs.
      2. Pembrolizumab: Pembrolizumab is a well-established medication in medical use and literature, primarily as an immunotherapy drug for cancer treatment. In this trial, it is administered intravenously and combined with other drugs like 5-FU and platinum-based chemotherapy in different cohorts.
      3. Docetaxel: Docetaxel is a chemotherapy medication that is widely known and used in oncology. In the trial, it is also given intravenously and is part of the therapeutic regimen for a specific patient cohort.
      4. 5-FU (Fluorouracil): 5-FU is a well-known chemotherapy agent used to treat various types of cancer. In this trial, it is part of the treatment combinations and is administered intravenously.
      5. Cisplatin: Cisplatin is a commonly used platinum-based chemotherapy drug that is broadly documented in medical literature. It is included in the trial as an intravenous chemotherapy option.
      6. Carboplatin: Carboplatin is another platinum-based chemotherapy medication with a well-established profile in medical usage and literature. It is used as an alternative to cisplatin in the trial and is given intravenously.
      7. Zimberelimab: Zimberelimab’s status in medical literature could not be verified from the given document alone. Additional searches in medical databases or consultation with a medical professional may be necessary to confirm its novelty or established use.

      If you need any additional information or clarification regarding these substances, feel free to ask.


      Study ID

      CT-EU-00067927

      Recruitment status

      Recruting new patients

      Start of the trial

      3 years ago