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Study Comparing ABP 206 and Nivolumab for Patients with Unresectable or Metastatic Melanoma

Fast replyRegistered 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 skin cancer called unresectable or metastatic melanoma. This means the melanoma cannot be removed by surgery or has spread to other parts of the body. The study is comparing two treatments: ABP 206 and OPDIVO® (nivolumab). Both treatments are given through an intravenous infusion, which means they are administered directly into a vein.

The purpose of the study is to evaluate how effective and safe ABP 206 is compared to OPDIVO® in patients who have not received any previous treatment for their advanced melanoma. Participants in the study will receive either ABP 206 or OPDIVO® for a period of up to 24 months. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments. The study will monitor the response to the treatment, including any changes in the size of the melanoma, and will also track any side effects or immune reactions that may occur.

Throughout the study, participants will have regular check-ups to assess their health and the progress of their melanoma. The study aims to provide valuable information on the effectiveness of ABP 206 compared to OPDIVO® in treating unresectable or metastatic melanoma, potentially offering new insights into treatment options for this condition.

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, the patient will be randomly assigned to receive either ABP 206 or OPDIVO (nivolumab).

    Both medications are administered as a solution for infusion through a vein (intravenous administration).

  2. Step 2

    Treatment administration

    The patient will receive the assigned medication at a dosage of 10 mg/mL.

    The frequency and duration of administration will be determined by the study protocol, which aims to evaluate the efficacy and safety of the treatments.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's response to the treatment will be monitored. This includes regular assessments to measure the size of the melanoma and any changes in the condition.

    The primary goal is to observe the objective response by week 49.

  4. Step 4

    Secondary assessments

    Secondary assessments will include evaluating the objective response at week 17, progression-free survival (PFS), overall survival (OS), and duration of response (DOR).

    Safety assessments will focus on any adverse events that occur during the treatment.

  5. Step 5

    Immunogenicity and pharmacokinetics

    The study will also assess the immunogenicity, which involves checking for the presence of anti-drug antibodies (ADAs).

    Pharmacokinetic assessments will measure the concentration of ABP 206 and nivolumab in the blood.

  6. Step 6

    Completion of the study

    The study is expected to conclude by May 15, 2025.

    Upon completion, the data collected will be analyzed to determine the efficacy and safety of the treatments.

Who can join the trial?

15 criteria

  • The participant can be a man or a woman and must be at least 18 years old at the time of screening.
  • The participant must have a confirmed diagnosis of stage III (unresectable) or stage IV melanoma, which is a type of skin cancer that cannot be removed by surgery or has spread to other parts of the body.
  • The participant must have a measurable disease, meaning the cancer can be measured in size using specific guidelines called RECIST.
  • Tumor tissue from the removed cancer site must be available for testing to help with the study.
  • The participant must not have received any previous treatment that affects the whole body for advanced melanoma. However, previous treatments given after surgery or before surgery are allowed if they were completed at least 6 months before joining the study. Previous radiation therapy to relieve symptoms is allowed if it was completed at least 2 weeks before starting the study treatment.
  • For women who are not at least 2 years past menopause or not surgically unable to have children, a negative pregnancy test is required during screening and at the start of the study.
  • The participant must have a good general health status, with a score of 0 or 1 on a scale used to assess daily living abilities called the Eastern Cooperative Oncology Group (ECOG) performance status.
  • The participant's blood test results must meet specific criteria within 14 days before joining the study, including:
    • White blood cell count of at least 2000 per microliter.
    • Neutrophils (a type of white blood cell) of at least 1500 per microliter.
    • Platelets (cells that help with blood clotting) of at least 100,000 per microliter.
    • Hemoglobin (a protein in red blood cells) of at least 9.0 grams per deciliter.
    • Creatinine (a waste product in the blood) within normal limits or creatinine clearance (a measure of kidney function) greater than 40 milliliters per minute.
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT), which are liver enzymes, must be no more than 3 times the upper limit of normal.
    • Total bilirubin (a substance made by the liver) must be no more than 1.5 times the upper limit of normal, except for those with Gilbert Syndrome, who must have total bilirubin less than 3.0 milligrams per deciliter.
    • The participant must be able to understand and sign a consent form approved by an ethics committee before any study-specific procedures are done.

Who cannot join the trial?

8 criteria

  • Patients who have already received treatment for their advanced melanoma cannot participate.
  • Patients with other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had another type of cancer in the past, unless it was successfully treated and is not currently active, cannot participate.
  • Patients with certain infections, like HIV or hepatitis, cannot participate.
  • Patients who are taking medications that might interfere with the study treatment cannot participate.
  • Patients with a history of severe allergic reactions to similar treatments cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate.
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Investigated drugs

  • ABP 206

    is an investigational medication being studied for its effectiveness in treating patients with melanoma that cannot be surgically removed or has spread to other parts of the body. This medication is being compared to an existing treatment to see how well it works in patients who have not received any previous systemic treatment for their advanced melanoma.

  • Opdivo (Nivolumab)

    is a medication already used in the treatment of melanoma. It works by helping the immune system to recognize and attack cancer cells. In this study, it serves as a comparison to evaluate the effectiveness and safety of the investigational medication ABP 206 in patients with advanced melanoma.

What is already known about the treatment

  • ABP 206

    ABP 206 is administered intravenously and is currently being evaluated in clinical trials for its effectiveness in treating unresectable or metastatic melanoma. It is not yet approved for general medical use, as it is still under investigation to determine its safety and efficacy compared to existing treatments. The main therapeutic indication for ABP 206 is in patients with melanoma that cannot be surgically removed or has spread to other parts of the body. Its mechanism of action involves modulating the immune system to target and destroy cancer cells, similar to other immunotherapy agents. ABP 206 is classified as an immunotherapy drug, specifically a checkpoint inhibitor, which helps the immune system recognize and attack cancer cells more effectively.

  • Nivolumab

    Nivolumab, marketed under the brand name Opdivo, is administered intravenously and is an approved medication used to treat various types of cancer, including unresectable or metastatic melanoma. It is well-documented in medical literature and widely used in clinical practice. The main therapeutic indication for nivolumab is to treat advanced melanoma, among other cancers, by enhancing the body's immune response against cancer cells. At the molecular level, nivolumab works by blocking the PD-1 pathway, a mechanism that tumors use to evade the immune system. It is classified as an immunotherapy drug, specifically a PD-1 inhibitor, which helps the immune system detect and fight cancer cells.

Investigated diseases

Unresectable or Metastatic Melanoma – This is a type of skin cancer that has spread beyond the original site and cannot be removed through surgery. It often begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, lungs, liver, brain, and bones. The spread of melanoma to distant sites is referred to as metastasis, which can complicate treatment and management. Symptoms may include changes in existing moles, the appearance of new pigmented or unusual-looking growths on the skin, and, in advanced stages, symptoms related to the affected organs. Early detection and monitoring of skin changes are crucial in managing the progression of this disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503288-40-00Protocol code20210031Estimated enrolment951 patientsSponsorAmgen Inc.

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