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Study on Long-term Safety of Nivolumab and Drug Combination for Cancer Patients from Previous BMS Trials

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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 long-term safety of the medication nivolumab, either used alone or in combination with other cancer treatments. The study is designed for patients who have previously participated in trials sponsored by BMS, a pharmaceutical company, and are dealing with various types of cancer, collectively referred to as pan tumor. The main goal is to ensure that the treatments continue to be safe for patients over an extended period.

Participants in this study will continue to receive their cancer treatment as they did in their previous trial, which may include nivolumab or other therapies. The study will monitor the occurrence of any side effects, including those that might lead to stopping the treatment, serious side effects, and immune-related side effects. The study will also track the overall survival of participants, which means observing how long patients live after starting the treatment in the study.

The study will run until 2030, allowing researchers to gather comprehensive data on the long-term effects of these cancer treatments. This information will help in understanding the safety and effectiveness of nivolumab and its combinations with other therapies for patients with different types of cancer. Participants will be required to follow the treatment schedule and attend regular check-ups to ensure their safety and the collection of accurate data.

The research process

The trial runs in 4 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 participant will begin by taking part in a long-term treatment plan. This plan is designed for those who have previously participated in trials involving nivolumab and other cancer therapies.

    The main goal is to assess the long-term safety of nivolumab, either alone or combined with other treatments.

  2. Step 2

    Treatment administration

    Participants will receive nivolumab and potentially other cancer therapies. The specific medications and their administration routes include oral and intravenous options.

    For example, nivolumab is administered as a solution for infusion, while other medications like capecitabine are taken orally as film-coated tablets.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular monitoring to evaluate the incidence of adverse events. This includes any side effects related to the treatment, serious adverse events, and immune-mediated reactions.

    Participants will also be assessed for overall survival, which is measured from the start of the study until the date of death from any cause or the last known date alive.

  4. Step 4

    Study duration

    The study is expected to continue until August 22, 2030. Participants will remain in the study as long as they meet the eligibility criteria and continue to benefit from the treatment.

    The study's progress will be evaluated periodically to ensure the safety and well-being of all participants.

Who can join the trial?

5 criteria

  • Participants must have signed a written informed consent. This means they agree to join the study after understanding what it involves.
  • Participants must be willing and able to attend scheduled visits, follow the treatment plan, undergo lab tests, and meet other study requirements.
  • Participants must be eligible to continue receiving study treatment as per the rules of the Parent Study. This includes continuing treatment even if the disease seems to progress, as assessed by the study doctor.
  • Participants must be on a treatment break in the Parent Study after showing a long-lasting response or be eligible to restart treatment as defined in the Parent Study.
  • Both male and female participants are eligible to join 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 part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have a medical condition that could interfere with the study treatment or its evaluation.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or a serious illness.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who have a history of certain heart, liver, or kidney problems.
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Investigated drugs

Nivolumab is a medication used in cancer treatment. It works by helping your immune system attack cancer cells. In this trial, it is being studied for its long-term safety when used alone or with other cancer therapies.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently well-established in medical literature as an immunotherapy used in the treatment of various types of cancer. The main therapeutic indication for nivolumab is to treat tumors, often in patients who have previously participated in clinical trials involving this medication. At the molecular level, nivolumab works by blocking the PD-1 protein on immune cells, which enhances the body's immune response against cancer cells. It is classified pharmacologically as a checkpoint inhibitor, a type of immunotherapy that helps the immune system recognize and attack cancer cells.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. If the spread is not controlled, it can interfere with essential bodily functions. Cancer can develop in almost any organ or tissue, such as the lung, colon, breast, skin, bones, or nerve tissue. The progression of cancer can vary greatly depending on the type and location of the cancer, as well as the individual characteristics of the patient. Some cancers grow and spread rapidly, while others grow more slowly. The disease can remain localized or spread to other parts of the body through the blood and lymph systems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506914-32-00Protocol codeCA209-8TTEstimated enrolment588 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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