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Study of Nivolumab for Children and Adults with Relapsed or Refractory ALK+ Anaplastic Large Cell Lymphoma

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 a type of cancer called anaplastic large cell lymphoma (ALCL), which is a rare form of non-Hodgkin lymphoma. Specifically, the trial is looking at cases where the cancer has returned or not responded to previous treatments, known as relapsing/refractory ALK+ anaplastic large cell lymphoma. The treatment being tested in this study is a medication called nivolumab, which is also known by its code name BMS936558. Nivolumab is a type of immunotherapy, which means it helps the body's immune system fight cancer.

The purpose of this study is to evaluate how effective nivolumab is in treating patients with this type of lymphoma. The study is divided into two groups, or cohorts. In the first group, patients with active disease will receive nivolumab to see how well it can reduce or eliminate the cancer. In the second group, patients who are in complete remission after a relapse will receive nivolumab as a way to help keep the cancer from coming back. The study will monitor patients over a period of time to assess their response to the treatment and to track their health and any side effects they may experience.

Participants in the study will receive nivolumab through an intravenous infusion, which means the medication is given directly into a vein. The study will follow patients for several years to gather information on the long-term effects and benefits of the treatment. This research aims to provide valuable insights into the potential of nivolumab as a treatment option for patients with relapsing or refractory ALK+ anaplastic large cell lymphoma.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria related to the medical condition, age, and previous treatments.

    Written informed consent is required from the patient or their legal representative.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of nivolumab, a medication given through an intravenous (IV) infusion.

    The medication is provided as a solution for infusion, known as OPDIVO 10 mg/mL.

  3. Step 3

    Treatment schedule

    For patients in Cohort 1, the focus is on evaluating the response to nivolumab within the first 24 weeks.

    For patients in Cohort 2, nivolumab is used as a consolidative therapy after achieving complete remission.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring is conducted to assess the treatment's effectiveness and any side effects.

    Evaluations include imaging tests and laboratory assessments to track disease progression or remission.

  5. Step 5

    End of treatment

    The primary endpoint for Cohort 1 is the best objective response rate within 24 weeks.

    For Cohort 2, the primary endpoint is progression-free survival, which measures the time until relapse or death.

  6. Step 6

    Follow-up

    Long-term follow-up is conducted to monitor the patient's health and any long-term effects of the treatment.

    This follow-up period can extend up to 5 years after the study inclusion.

Who can join the trial?

18 criteria

  • Must have a confirmed diagnosis of **relapsed/refractory ALK+ Anaplastic Large Cell Lymphoma (ALCL)**. If a biopsy can't be done, the condition should be confirmed by a special test called **molecular analysis**.
  • Must be older than 6 months.
  • Must have recovered from any immediate side effects of previous treatments before joining the study. A short course of **steroids** is allowed if needed.
  • Must have **adequate organ function**, which means:
    • Enough **neutrophils** (a type of white blood cell) and **platelets** (cells that help with blood clotting) in the blood.
    • **Hemoglobin** levels should be at least 8.0 g/dL (blood transfusion is allowed if needed).
    • **Serum creatinine** should be within normal limits for age, indicating healthy kidneys.
    • **Total bilirubin** should be within normal limits, indicating healthy liver function.
    • **Liver enzymes** (ALT and AST) should be within normal limits, indicating healthy liver function.
    • Must have a **performance status** of at least 40%, which means being able to perform daily activities to some extent.
    • Must be able to follow the treatment plan and manage any side effects.
    • Females who can have children must have a negative pregnancy test before starting treatment and agree to use birth control during the study and for 5 months after. Males must agree to use condoms during the study and for 7 months after.
    • Must have written consent from parents or legal representatives, and the patient must agree to participate if they are old enough to understand.
    • Must be part of a social security system or have similar coverage as required locally.
    • Patients who had a previous **allogeneic hematopoietic stem cell transplant (HSCT)** may join if it's necessary, but this must be confirmed by the study's main investigator.
    • For **Cohort 1**:
      • Must have a measurable disease with at least one lesion larger than 1.5 cm or visible disease on a **PET-CT scan**.
      • Must have had previous treatment with **chemotherapy** and an **ALK inhibitor** or **brentuximab vedotin**, if available.
      • For **Cohort 2**:
        • Must have a **complete response**, meaning no visible disease except for possible minimal disease in blood or bone marrow, with ongoing treatment for at least 2 months with an ALK inhibitor or brentuximab vedotin, possibly combined with chemotherapy.
        • Must be considered high-risk and eligible for a **stem cell transplant** after achieving a complete response.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not experienced a return or worsening of their cancer after treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent infection or illness that could affect the study results.
  • Patients who are currently participating in another clinical trial.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have received certain treatments recently that could interfere with the study.
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Investigated drugs

Nivolumab is a medication used in this clinical trial to treat patients with a specific type of lymphoma called ALK+ anaplastic large cell lymphoma (ALCL). It is being tested for its effectiveness in two different groups of patients. In the first group, it is used to see how well it works in patients whose disease has returned or did not respond to previous treatments. In the second group, it is used as a follow-up treatment to help maintain remission in patients who have already responded well to previous treatments.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating relapsing or refractory ALK-positive anaplastic large cell lymphoma, particularly in pediatric and adult patients. The medication works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Relapsing/Refractory ALK+ Anaplastic Large Cell Lymphoma – This is a type of non-Hodgkin lymphoma characterized by the presence of anaplastic large cells that express the ALK protein. It typically begins in the lymph nodes but can also affect other parts of the body. The disease is known for its aggressive nature and tendency to relapse or become resistant to initial treatments. Patients may experience symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases responding well to treatment while others may continue to progress. The presence of the ALK protein is a key factor in the behavior and treatment response of this lymphoma.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516807-17-00Protocol codeCSET N°2018/2706Estimated enrolment43 patientsSponsorInstitut Gustave Roussy

sourced from the EU Clinical Trials Register and site verification

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