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Study on Nivolumab Dose Optimization for Patients with Melanoma or Renal Cell Carcinoma Showing Complete, Partial, or Stable Response

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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 medication called nivolumab in patients with certain types of cancer, specifically melanoma and renal cell carcinoma. Nivolumab is a type of treatment known as an immunotherapy, which helps the body's immune system fight cancer. The purpose of the study is to optimize the dose of nivolumab for patients who have shown a complete, partial, or stable response to their current treatment.

Participants in the study will receive a reduced dose of nivolumab, administered through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the levels of the drug in the body to ensure they remain effective while using a lower dose. This approach aims to maintain the benefits of the treatment while potentially reducing side effects and costs.

The study will take place over a period of time, with regular assessments to check the drug levels and monitor any side effects. The goal is to determine if the reduced dose can maintain the same level of effectiveness as the higher dose previously used. This research could lead to improved treatment strategies for patients with melanoma and renal cell carcinoma, making their therapy more manageable and cost-effective.

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

    Participation begins after meeting specific criteria: age 18 or older, having advanced or metastatic melanoma or renal cell carcinoma, and currently receiving nivolumab treatment in a 6 mg/kg or 480 mg, 4-weekly scheme.

    A documented complete, partial, or stable response to treatment is required, and treatment must have been ongoing for at least 6 months.

  2. Step 2

    Initial treatment phase

    Continue receiving nivolumab at the current dosage of 6 mg/kg or 480 mg every 4 weeks.

    This phase ensures that the treatment response is stable before any adjustments are made.

  3. Step 3

    Dose adjustment phase

    The dosage of nivolumab is reduced to 240 mg, administered every 4 weeks through an intravenous infusion.

    This phase involves receiving three reduced doses to assess the treatment's effectiveness at a lower dosage.

  4. Step 4

    Monitoring and assessment

    The primary goal is to demonstrate that the nivolumab level remains adequate after the dosage reduction.

    Blood tests are conducted to measure the nivolumab level 4 weeks after the third reduced dose and compare it to the level 4 weeks after the initial treatment.

  5. Step 5

    Evaluation of secondary outcomes

    Additional assessments include measuring the PD-1 receptor occupancy in blood cells, monitoring for any significant adverse events, and evaluating the number of patients with new disease progression during the reduced doses.

    The pharmacokinetic profile of nivolumab and its cost-effectiveness are also analyzed.

  6. Step 6

    Completion of the trial

    The trial is expected to conclude by July 1, 2025, after all data has been collected and analyzed.

    Results will contribute to understanding the optimal dosing strategy for nivolumab in patients with a stable response.

Who can join the trial?

5 criteria

  • Must be **18 years or older**.
  • Have **advanced or metastatic melanoma** or **renal cell carcinoma (RCC)**. This means the cancer has spread to other parts of the body.
  • Currently receiving treatment with **nivolumab** in a specific dosage schedule of **6 mg/kg or 480 mg every 4 weeks**.
  • Have a **documented confirmed and ongoing response** to treatment, which can be complete response (CR), partial response (PR), or stable disease (SD) according to a specific set of guidelines called **RECIST v1.1**.
  • Have been on treatment for **at least 6 months**.

Who cannot join the trial?

3 criteria

  • Patients with conditions other than Melanoma or Renal cell carcinoma cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Nivolumab is a medication used in this trial to help the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells. The trial aims to find the best dose of nivolumab for patients who have shown a complete, partial, or stable response to previous treatments. The goal is to ensure that the medication maintains its effectiveness even when the dose is reduced.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, typically given in a healthcare setting. It is currently well-established in medical literature and is approved for use in treating conditions such as melanoma and renal cell carcinoma. The medication works by blocking a protein called PD-1 on the surface of immune cells, which enhances the body's immune response against cancer cells. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy that helps the immune system recognize and attack cancer cells more effectively.

Investigated diseases

  • Melanoma

    Melanoma is 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 often appears as a new mole or a change in an existing mole, and it can be identified by its irregular shape, multiple colors, or larger size. Melanoma can spread to other parts of the body if not detected early. It is more common in individuals with fair skin, a history of sunburns, or a family history of the disease. The progression of melanoma can vary, with some cases remaining localized while others may metastasize. Early detection and monitoring of skin changes are crucial in managing this condition.

  • Renal Cell Carcinoma

    Renal cell carcinoma is a type of kidney cancer that originates in the lining of the small tubes within the kidney. It is the most common type of kidney cancer in adults and often does not cause symptoms in its early stages. As it progresses, it may lead to symptoms such as blood in the urine, a lump in the abdomen, or unexplained weight loss. The disease can spread to other organs if not treated, but it typically grows slowly. Risk factors include smoking, obesity, and high blood pressure. Understanding the progression of renal cell carcinoma is important for managing the disease effectively.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516718-39-00Estimated enrolment34 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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