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Study on the Safety and Effects of Relatlimab and Nivolumab for Patients with Advanced Solid Tumors

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 the safety and effectiveness of treatments for advanced solid tumors, which are a type of cancer that forms in solid organs or tissues. The study involves the use of two medications: Relatlimab and Nivolumab. These medications are given as solutions through an intravenous infusion, which means they are administered directly into the bloodstream through a vein. The trial aims to understand how these medications work both when used alone and when combined, to see if they can help control or reduce the size of tumors.

The purpose of the study is to assess the safety and tolerability of these treatments, which means checking for any side effects and determining how well patients can handle the medications. The study will also gather preliminary information on how effective these treatments are in managing the disease. Participants will receive the medications in different doses and combinations to find the most effective and safest way to use them. The trial will also explore if a more convenient dosing schedule can be established for patients.

Throughout the study, participants will be monitored for any adverse events, which are unwanted effects that may occur during treatment. The trial will also measure how the body processes the medications, including how long they stay in the body and how they are eliminated. The study will continue until the estimated end date in 2026, with the goal of providing valuable information on the potential benefits of Relatlimab and Nivolumab for treating advanced solid tumors.

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 informed about the trial's objectives, procedures, and potential risks and benefits.

    The patient will provide consent to participate and may need to provide a tumor biopsy sample if available.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility, which includes a review of medical history and a physical examination.

    Baseline measurements of the disease will be taken to track progress throughout the trial.

  3. Step 3

    Treatment administration

    The patient will receive treatment with nivolumab and relatlimab through intravenous infusion.

    The dosage and frequency will vary depending on the specific part of the trial the patient is enrolled in. For example, in some parts, nivolumab 240 mg and relatlimab 80 mg may be administered every two weeks, while in others, nivolumab 480 mg and relatlimab 160 mg may be administered every four weeks.

  4. Step 4

    Monitoring and follow-up

    The patient will be monitored regularly for any side effects or adverse reactions to the treatment.

    Regular blood tests and other laboratory assessments will be conducted to ensure safety and to measure the treatment's effectiveness.

  5. Step 5

    Evaluation of response

    The patient's response to the treatment will be evaluated using criteria such as the objective response rate (ORR), disease control rate (DCR), and duration of response (DOR).

    These evaluations will help determine the treatment's effectiveness in controlling the disease.

  6. Step 6

    Completion of the trial

    Upon completion of the treatment period, the patient will undergo a final assessment to evaluate overall health and treatment outcomes.

    The patient may be asked to participate in follow-up visits to monitor long-term effects and gather additional data.

Who can join the trial?

10 criteria

  • Patients with certain types of cancer, such as cervical, ovarian, bladder, colorectal (CRC), head and neck, gastric, and liver cancer, who have not been treated with **immuno-oncology agents**. Immuno-oncology agents are treatments that help the immune system fight cancer.
  • Patients with **melanoma** (a type of skin cancer) who are receiving their first treatment or have received one or two treatments for **non-small cell lung cancer (NSCLC)**.
  • Patients with **renal cell carcinoma** (a type of kidney cancer) who have not been treated with immuno-oncology agents.
  • Patients with NSCLC or melanoma who have had their cancer progress during or after treatment with **anti-PD1/anti-PDL-1** therapies. These are treatments that block proteins that stop the immune system from attacking cancer cells.
  • Patients who have tried at least one standard treatment and it did not work or they could not tolerate it, except for those receiving their first treatment.
  • Patients with an **ECOG performance status** of 0 to 2. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • Patients must have at least one **measurable lesion** at the start of the study. A lesion is an area of abnormal tissue, and measurable means it can be measured in size.
  • Patients must have a sample of their tumor available for testing and agree to have a biopsy before treatment. A biopsy is a procedure to remove a small piece of tissue for examination.
  • Both male and female patients are eligible to participate.
  • Patients from vulnerable populations can participate.

Who cannot join the trial?

5 criteria

  • Patients with certain types of **cancer** that are not included in the study.
  • Patients who have not met the required **age range** for the study.
  • Patients who are not part of the specific **clinical trial groups** needed for the study.
  • Patients who are not **male** or **female**, as both genders are included in the study.
  • Patients who are considered part of a **vulnerable population**, which means they might need special protection or care.
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Investigated drugs

  • BMS-986016

    is an experimental medication being studied for its potential to treat advanced solid tumors. It is a monoclonal antibody that targets a specific protein called LAG-3, which is involved in regulating the immune system. By blocking this protein, BMS-986016 may help the immune system to better recognize and attack cancer cells.

  • Nivolumab

    is a medication that is already used to treat various types of cancer. It is a monoclonal antibody that targets the PD-1 protein on immune cells. By blocking PD-1, nivolumab can enhance the immune system's ability to fight cancer. In this trial, nivolumab is being used in combination with BMS-986016 to see if the two medications together can improve treatment outcomes for patients with advanced solid tumors.

What is already known about the treatment

BMS-986016 – This medication is administered as an injection and is currently being studied in clinical trials for its safety and effectiveness in treating advanced solid tumors, including melanoma. It is an experimental drug, not yet widely used in standard medical practice, and is being evaluated in combination with another drug, Nivolumab. BMS-986016 is primarily indicated for certain types of cancer, particularly those affecting specific body sites. It works by targeting and inhibiting the LAG-3 protein, which can help the immune system recognize and attack cancer cells more effectively. BMS-986016 is classified as a monoclonal antibody, a type of drug designed to interact with specific proteins in the body.

Investigated diseases

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, typically with irregular borders and multiple colors. Melanoma can occur anywhere on the body but is most common on areas exposed to the sun, such as the back, legs, arms, and face. As it progresses, melanoma can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. Early detection is crucial, as melanoma can be more aggressive than other types of skin cancer. Regular skin checks and monitoring of moles are important for early identification and management.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508067-70-00Protocol codeCA224-020Estimated enrolment2 000 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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