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Study of Subcutaneous Nivolumab with or without Recombinant Human Hyaluronidase PH20 for Patients with Lung, Kidney, Melanoma, Liver, Colorectal, or Bladder Cancer

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 several types of cancer, including lung cancer, kidney cancer, melanoma, liver cancer, colorectal cancer, and bladder cancer. The treatment being tested is a medication called nivolumab, which is given as a solution for injection. In some cases, it is combined with another substance called Recombinant Human Hyaluronidase PH20 (rHuPH20). The purpose of the study is to understand how the body processes nivolumab when it is administered under the skin, either alone or with rHuPH20.

Participants in the study will receive nivolumab in different forms, including subcutaneous injections and intravenous infusions. The study will observe how the medication moves through the body and how it is absorbed, distributed, and eliminated. This will help researchers understand the best way to administer nivolumab for treating these cancers. The study will also monitor for any side effects or reactions to the medication, including any allergic reactions or the development of antibodies against nivolumab.

The study is expected to continue until August 2025. During this time, participants will receive regular doses of the medication and will be closely monitored by the research team. The information gathered from this study will contribute to the understanding of nivolumab's effectiveness and safety in treating various types of cancer.

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 visit

    Upon joining the study, an initial visit is scheduled. During this visit, a healthcare professional will confirm eligibility based on specific criteria, such as the type of cancer and overall health status.

    A detailed explanation of the study procedures, potential risks, and benefits will be provided. Consent to participate will be obtained.

  2. Step 2

    Treatment administration

    The study involves the administration of the medication nivolumab. This medication is given in different forms: as a subcutaneous injection (under the skin) or as an intravenous infusion (into a vein).

    In some parts of the study, nivolumab is combined with another substance called Recombinant Human Hyaluronidase PH20 (rHuPH20) to help with absorption.

  3. Step 3

    Dosing schedule

    The dosing schedule varies depending on the part of the study. For example, in Part E, nivolumab is administered as a subcutaneous injection of 600 mg every two weeks.

    The healthcare team will provide specific instructions on the frequency and duration of the treatment.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effects of the treatment. This includes blood tests and other assessments to measure the concentration of nivolumab in the body.

    Participants are monitored for any side effects or reactions to the treatment. This includes checking for allergic reactions and other potential adverse effects.

  5. Step 5

    End of treatment

    At the end of the treatment period, a final evaluation is conducted. This includes a review of the participant's health status and any changes observed during the study.

    Participants may be asked to return for follow-up visits to monitor long-term effects and gather additional data.

Who can join the trial?

10 criteria

  • Confirmation of advanced (metastatic and/or unresectable) solid tumors in one of the following types:
    • Metastatic squamous or non-squamous NSCLC (a type of lung cancer)
    • Renal Cell Carcinoma (a type of kidney cancer), advanced or metastatic
    • Melanoma
    • Hepatocellular Carcinoma (a type of liver cancer)
    • Colorectal Cancer, metastatic (MSI-H or dMMR)
    • Urothelial carcinoma, metastatic (for Part E only)
    • Must have a measurable disease according to RECIST version 1.1 criteria (a standard way to measure how well a cancer treatment works)
    • Must have an ECOG performance status of 0 or 1 (a scale to assess how a disease affects daily living abilities, where 0 means fully active and 1 means some symptoms but nearly fully active)
    • Open to both male and female participants
    • Participants must be within the specified age range

Who cannot join the trial?

5 criteria

  • Patients with any other type of cancer not listed in the study, such as lung cancer, kidney cancer, melanoma, liver cancer, colorectal cancer, or bladder cancer, cannot participate.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

  • Nivolumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells. In this trial, nivolumab is given as a shot under the skin, which is different from the usual way it is given through a vein. This study is looking at how the body absorbs and processes nivolumab when it is given in this new way.

  • rHuPH20

    is a substance that helps medications spread more easily under the skin. It is used in this trial to see if it can help nivolumab work better when given as a shot under the skin. By combining rHuPH20 with nivolumab, researchers hope to improve the delivery and effectiveness of the cancer treatment.

What is already known about the treatment

Nivolumab – Nivolumab is administered as a subcutaneous injection, which means it is given under the skin. It is currently being studied in clinical trials for its effectiveness in treating various types of cancer, including lung, kidney, melanoma, liver, colorectal, and bladder cancers. The main purpose of nivolumab is to help the immune system recognize and attack cancer cells. It works by blocking a specific protein on the surface of immune cells, which allows these cells to better identify and destroy cancer cells. Nivolumab is classified as an immune checkpoint inhibitor, a type of medication that enhances the body's natural defenses against cancer.

Investigated diseases

  • Lung Cancer

    Lung cancer is a disease characterized by the uncontrolled growth of abnormal cells in one or both lungs. These abnormal cells do not develop into healthy lung tissue and can form tumors. As the disease progresses, these tumors can interfere with the lung's ability to provide oxygen to the bloodstream. The cancer can spread to other parts of the body through the lymphatic system or bloodstream. Symptoms may include persistent cough, chest pain, and shortness of breath. The progression can vary depending on the type and stage of the cancer.

  • Kidney Cancer

    Kidney cancer begins in the kidneys, which are two bean-shaped organs located behind the abdominal organs. The most common type is renal cell carcinoma, which starts in the lining of small tubes in the kidney. As the disease progresses, it can lead to the formation of a mass or tumor in the kidney. This can affect kidney function and potentially spread to other parts of the body. Symptoms may include blood in the urine, back pain, and weight loss. The progression can vary based on the size and spread of the tumor.

  • Melanoma

    Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It often appears as a new mole or a change in an existing mole. As melanoma progresses, it can invade deeper layers of the skin and spread to other parts of the body. This spread can occur through the lymphatic system or bloodstream. Symptoms may include changes in the size, shape, or color of a mole. The progression can vary depending on the depth of skin invasion and spread to other organs.

  • Liver Cancer

    Liver cancer is a disease in which malignant cells form in the tissues of the liver. The most common type is hepatocellular carcinoma, which starts in the main type of liver cell. As the disease progresses, it can lead to the formation of tumors that impair liver function. These tumors can also spread to other parts of the body. Symptoms may include weight loss, loss of appetite, and jaundice. The progression can vary based on the size and number of tumors.

  • Colorectal Cancer

    Colorectal cancer begins in the colon or rectum, which are parts of the large intestine. It typically starts as a growth called a polyp on the inner lining of the colon or rectum. As the disease progresses, these polyps can become cancerous and invade deeper layers of the colon or rectum. The cancer can spread to other parts of the body through the lymphatic system or bloodstream. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression can vary depending on the size and spread of the cancer.

  • Bladder Cancer

    Bladder cancer is a disease in which malignant cells form in the tissues of the bladder. The most common type is transitional cell carcinoma, which begins in the cells lining the bladder. As the disease progresses, it can lead to the formation of tumors that affect bladder function. These tumors can also spread to other parts of the body. Symptoms may include blood in the urine, frequent urination, and pelvic pain. The progression can vary based on the size and spread of the tumors.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503554-12-00Protocol codeCA209-8KXEstimated enrolment220 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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