RecruitingPHASE2INTERVENTIONAL

Pan Tumor Rollover Study

This research study, called the "Pan Tumor Rollover Study," is designed to look closely at the long-term safety of several cancer treatments for people with various types of cancer. These treatments include a medicine called nivolumab, sometimes on its own and sometimes combined with other anti-cancer drugs. Other medications like ipilimumab, cabozantinib, and pembrolizumab are also being studied. The main goal is to understand how these treatments affect patients over a longer period. This study is generally for adults aged 18 and over, and it's open to both men and women. It is a 'Phase 2' study, which means it builds on earlier research to gather more information about how safe and effective these treatments are.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Bristol-Myers Squibb

Enrolment target

1,500

Start

09 Aug 2019

Estimated completion

25 Aug 2029

Cancer

What is this study about?

This study is called a "Pan Tumor Rollover Study" because it involves people with different types of cancer (pan-tumor) who are continuing their treatment from a previous study (rollover). The main purpose is to carefully check the long-term safety of several cancer medicines. The key medicines being looked at include nivolumab, which is an immunotherapy that helps your body’s immune system fight cancer, as well as combinations of nivolumab with other drugs like relatlimab. Other cancer treatments such as ipilimumab, cabozantinib, and pembrolizumab are also part of this research.

Understanding the long-term safety of cancer treatments is really important. While treatments can help fight cancer, they can also have side effects, and it's crucial to know what these might be over a longer period. By continuing to monitor patients who have already been receiving these treatments in an earlier study, researchers can gather valuable information about how these medications behave when used for an extended time.

This information helps doctors make better decisions about how to use these treatments in the future, ensuring that patients receive the most effective care with the fewest possible risks. This study is considered a 'Phase 2' trial, which means it aims to find out more about how well the treatments work and what their side effects are in a larger group of people, after earlier, smaller studies have shown promising results.

Key takeaways

This study focuses on the long-term safety of cancer treatments.
It's for people continuing treatment from a previous study for various cancers.
Commonly studied drugs include nivolumab, alone or with others.
Participation involves ongoing medical check-ups and monitoring.
The findings will help doctors better understand these treatments.
You can leave the study at any time.

Who may be eligible?

To join this study, you must first have been part of a previous, related study and still be receiving treatment there, or be eligible to continue. This means your doctors believe you are still benefiting from the treatment you were receiving in that original study.

You would also need to be able to safely continue these treatments as judged by your doctor. If you are female and able to become pregnant, or a male who is sexually active, you must agree to use effective birth control methods throughout the study, as outlined in the study’s consent form.

Things that might prevent you from joining include not benefiting from your current treatment, or if your doctor believes that participating in the study isn't in your best interest due to other health issues or problems found in blood tests. Also, if you don't meet the requirements for continuing in the original study, you wouldn't be able to join this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you been part of a previous (parent) study involving these treatments?
Are you still benefiting from the treatment you were receiving in that previous study?
Does your doctor believe it's safe for you to continue your current study treatment?
If you are female and could become pregnant, or a sexually active male, are you willing to use birth control?
Are you at least 18 years old?

Answer every question to see your result.

What does participation involve?

As this is a 'rollover' study, it means you're already familiar with some aspects of trial participation. You would continue to receive your study medication (like nivolumab or one of the other listed treatments) as prescribed. This typically involves regular visits to the hospital or clinic for your treatment and check-ups. During these visits, the study team will carry out medical assessments, which might include blood tests, physical examinations, and scans, to keep a close eye on your health and how you're responding to the treatment. They will also look for any side effects.

The frequency of visits and specific tests will depend on the medicine you are receiving and the study plan, but they are designed to safely monitor you in the long term. You will also have follow-up appointments to track your progress and any long-term effects. The total duration of your participation will depend on how you respond to the treatment and the study design, but the main aim is to understand long-term safety.

Potential risks and benefits

Participating in research studies like this can offer potential benefits, such as continued access to cancer treatments that may be helping you. It also means you will be closely monitored by medical professionals, which can be reassuring. For others, your participation helps build a more complete understanding of these treatments, which could benefit future patients. However, like all medications, those used in this study (such as nivolumab, ipilimumab, and others) can have side effects. These can range from mild to more serious, and the study team will discuss potential risks specific to your treatment. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (399)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Local Institution - 0220
Verified postcode
Huntsville, United States· Completed
University of Arizona College of Medicine
Verified postcode
Tucson, United States· Withdrawn
Innovative Clinical Research Institute
Verified postcode
Lynwood, United States· Withdrawn
Local Institution
Verified postcode
San Francisco, United States· Withdrawn
Local Institution - 0099
Verified postcode
San Francisco, United States· Completed
Local Institution - 0233
Verified postcode
Aurora, United States· Completed
Local Institution - 0095
Verified postcode
New Haven, United States· Withdrawn
Local Institution - 0088
Verified postcode
Washington D.C., United States· Completed
Florida Cancer Affiliates
Verified postcode
Ocala, United States· Withdrawn
Local Institution
Verified postcode
Orlando, United States· Withdrawn
Local Institution - 0024
Verified postcode
Tampa, United States· Completed
Local Institution - 0105
Verified postcode
Chicago, United States· Completed

Common questions

What does 'Pan Tumor' mean?

It means the study includes people with different types of cancer, not just one specific kind.

What is 'Phase 2'?

Phase 2 is a stage of research where doctors study a treatment in a larger group of people to see if it works and what side effects it might have, after earlier smaller studies have shown promise.

Why is 'long-term safety' important?

It's important to understand how a medicine affects the body over a longer period, not just short-term, so doctors can make informed decisions about its use.

Will I get a new cancer treatment?

This study is mainly for people already receiving treatment in a related study, so it's about continuing and checking the safety of the treatments you've been on, rather than starting entirely new ones.

Can I leave the study if I want to?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.