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Study of Subcutaneous Nivolumab for Patients with Previously Treated Advanced or Metastatic Clear Cell Kidney Cancer

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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 kidney cancer known as advanced or metastatic clear cell renal cell carcinoma. This is a condition where cancer cells form in the lining of the tubules in the kidney and have spread to other parts of the body. The study is investigating a treatment called nivolumab, which is a medication that helps the immune system fight cancer. Nivolumab is being tested in two forms: one that is given through a vein, known as intravenous nivolumab, and another that is injected under the skin, called subcutaneous nivolumab. The subcutaneous form is also referred to by its code name, BMS-986298.

The purpose of this study is to compare the effectiveness of the subcutaneous form of nivolumab to the intravenous form in patients who have already received other treatments for their cancer. Participants in the study will be randomly assigned to receive either the subcutaneous or intravenous form of nivolumab. The study will monitor how the medication is processed in the body and its effects on the cancer over time. Some participants may receive a placebo, which is a substance with no active medication, to help compare the results.

Throughout the study, participants will have regular check-ups to monitor their health and the progress of their cancer. The study aims to provide valuable information on whether the subcutaneous form of nivolumab is as effective as the intravenous form, potentially offering a more convenient treatment option for patients with advanced kidney cancer. The study is expected to continue for several years to gather comprehensive data on the treatment's long-term effects and safety.

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 is conducted to confirm eligibility. This includes verifying a diagnosis of advanced or metastatic clear cell renal cell carcinoma.

    Eligibility criteria include having received no more than two prior systemic treatments and showing intolerance or progression after the last treatment.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either subcutaneous nivolumab or intravenous nivolumab. This process ensures that each participant has an equal chance of receiving either form of the medication.

  3. Step 3

    Treatment administration

    The treatment involves the administration of nivolumab, which is a medication used to treat certain types of cancer.

    For those receiving the intravenous form, the medication is given as a solution for infusion. For those receiving the subcutaneous form, it is given as a solution for injection.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for their response to the treatment and any side effects. This includes regular blood tests and imaging studies to assess the cancer's response.

    The study measures various outcomes, such as the time-averaged serum concentration of the medication and the objective response rate, over a period of up to five years.

  5. Step 5

    Completion of study

    The study is expected to conclude by February 2025. Participants will continue to be monitored for long-term outcomes, including overall survival and progression-free survival.

Who can join the trial?

7 criteria

  • You must have a confirmed diagnosis of **renal cell carcinoma (RCC)**, which is a type of kidney cancer, with a clear cell component. This includes cases that may have **sarcomatoid features**, which are specific characteristics of the cancer cells.
  • Your RCC must be **advanced**, meaning it cannot be cured with surgery or radiation, or it must be **metastatic**, which means the cancer has spread to other parts of the body (Stage IV).
  • You must have a **measurable disease** as defined by specific criteria used to assess tumors, known as **RECIST v1.1**, within 28 days before being randomly assigned to a treatment group.
  • You should have received no more than 2 previous **systemic treatment regimens**, which are treatments that affect the entire body, such as chemotherapy.
  • You must have experienced **intolerance** (unable to tolerate) or **progression** (worsening) of the disease on or after the last treatment regimen you received, and this must have occurred within 6 months before being randomly assigned to a treatment group.
  • Your **Karnofsky Performance Status (PS)** must be 70 or higher at the time of screening. This is a scale that measures your ability to perform everyday activities, with 100 being fully active and 0 being deceased.
  • If applicable, you must agree to follow specific methods of **contraception** to prevent pregnancy during the study.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who are taking medications that might interfere with the study treatment.
  • Patients who have a history of substance abuse or alcohol dependency.
  • Patients who have an infection that requires treatment with antibiotics.
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Investigated drugs

Nivolumab: This medication is used in the trial to treat participants with advanced or metastatic clear cell renal cell carcinoma. It is an immunotherapy drug that helps the body's immune system to fight cancer cells. In this study, Nivolumab is being tested in two different forms of administration: subcutaneous (under the skin) and intravenous (into a vein). The trial aims to compare these two methods to see if the subcutaneous form is as effective as the intravenous form.

What is already known about the treatment

Nivolumab – Nivolumab is administered either as a subcutaneous injection or an intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic clear cell renal cell carcinoma, particularly in patients who have previously received systemic therapy. 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 used in cancer treatment.

Investigated diseases

Metastatic Clear Cell Renal Cell Carcinoma – This is a type of kidney cancer that originates in the cells lining the small tubes within the kidney. It is characterized by the spread of cancer cells beyond the kidney to other parts of the body, such as the lungs, bones, or liver. The disease often progresses silently in its early stages, making it difficult to detect until it has metastasized. As it advances, symptoms may include blood in the urine, persistent pain in the side or back, and unexplained weight loss. The progression of the disease can vary, with some individuals experiencing rapid spread while others may have a slower course. The clear cell subtype is the most common form of renal cell carcinoma, known for its distinct appearance under a microscope.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503280-42-00Protocol codeCA209-67TEstimated enrolment932 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).