Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
This study is testing a new drug called relatlimab. It's for people with nasopharyngeal cancer that has either returned after getting better or has spread to other parts of the body. Participants first receive standard treatment, which includes chemotherapy (cisplatin/carboplatin and gemcitabine) and an immunotherapy drug called nivolumab. After this initial treatment, the study aims to see if adding relatlimab to nivolumab can stop the cancer from growing or spreading for a longer time compared to just continuing with nivolumab. This is a Phase 2 study, meaning it's still in the earlier stages of research.
At a glance
What is this study about?
This research study is investigating an important question for people affected by nasopharyngeal cancer that has either returned after initial treatment or has spread to other parts of the body. Doctors are always looking for better ways to treat cancer, and this study focuses on seeing if an additional drug can improve on current standard treatments.
Currently, the usual first step for this type of cancer involves a combination of chemotherapy drugs like cisplatin or carboplatin with gemcitabine, alongside an immunotherapy drug called nivolumab. Immunotherapy helps your body's own immune system fight the cancer. After this initial treatment, if the cancer is under control, patients often continue to receive nivolumab to help prevent the cancer from coming back or growing.
This study is testing whether adding a new drug, BMS-986016, also known as relatlimab, to the ongoing nivolumab treatment can make a difference. Relatlimab is a type of drug designed to interfere with how cancer cells grow and spread. The main goal is to see if this combination therapy can keep the cancer from getting worse for a longer period compared to just receiving nivolumab alone. This could potentially offer renewed hope for patients facing this challenging disease.
Key takeaways
- This study is for recurrent or metastatic nasopharyngeal cancer.
- It tests adding a new drug, relatlimab, to current immunotherapy (nivolumab).
- The goal is to see if the new combination can control cancer for longer.
- Initial treatment includes chemotherapy and immunotherapy.
- Regular scans and tests will monitor your health.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you would generally need to have nasopharyngeal cancer that has either returned in the same area or spread to other parts of your body. If your cancer returned in the same area, it must not be possible to treat it with surgery or further radiation.
You also need to have clear signs of the cancer that can be measured, for example, on scans. Your cancer cells must show certain genetic markers, specifically related to the Epstein-Barr virus (EBV), or you must have had detectable EBV in your blood at some point since your diagnosis.
Important note: This study is for adults aged 18 and over. If you have active brain or spinal cord spread of cancer with symptoms, or if you're taking high doses of steroids for it, you might not be eligible immediately. However, if these issues have been stable for a couple of months and you're off high-dose steroids, you might still qualify. Your doctor will be able to check all the specific details with you.
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.
- Is your nasopharyngeal cancer recurrent (come back) or metastatic (spread)?
- Is your cancer confirmed to have certain EBV markers?
- Are you 18 years old or older?
- Do you have measurable cancer on scans?
- Are any brain/spinal cord metastases stable and not requiring high-dose steroids?
- Can you commit to regular hospital visits and tests?
What does participation involve?
If you join this study, you will first receive an initial treatment phase. This involves getting nivolumab, cisplatin (or carboplatin), and gemcitabine through a drip into your vein. These treatments are given on specific days over a 21-day cycle, for up to 6 cycles, as long as your cancer isn't getting worse.
Following this initial treatment, if your cancer is stable, you could continue onto the next phase. In this phase, you would either receive nivolumab on its own, or nivolumab combined with the new drug, relatlimab. Both drugs are given through a drip. Throughout the study, you'll have regular hospital visits for blood tests, physical exams, and imaging scans like CT, MRI, PET, and bone scans to monitor your health and how the treatment is working. This might vary but could involve monthly or less frequent visits. Biospecimen collections (like extra blood or tissue samples) will also be taken for future research. The total duration of your participation would depend on how your treatment progresses, but regular follow-up scans and checks continue even after you stop active treatment.
Potential risks and benefits
Locations (88)
- Kaiser Permanente DublinVerified postcodeDublin, United States· Recruiting
- Kaiser Permanente-FremontVerified postcodeFremont, United States· Recruiting
- Kaiser Permanente Fresno Orchard PlazaVerified postcodeFresno, United States· Recruiting
- Kaiser Permanente-FresnoVerified postcodeFresno, United States· Recruiting
- Keck Medicine of USC KoreatownVerified postcodeLos Angeles, United States· Recruiting
- Los Angeles General Medical CenterVerified postcodeLos Angeles, United States· Recruiting
- USC / Norris Comprehensive Cancer CenterVerified postcodeLos Angeles, United States· Recruiting
- Kaiser Permanente- Modesto MOB IIVerified postcodeModesto, United States· Recruiting
- Kaiser Permanente-ModestoVerified postcodeModesto, United States· Recruiting
- USC Norris Oncology/Hematology-Newport BeachVerified postcodeNewport Beach, United States· Recruiting
- Kaiser Permanente-OaklandVerified postcodeOakland, United States· Recruiting
- Stanford Cancer Institute Palo AltoVerified postcodePalo Alto, United States· Recruiting
Common questions
What is nasopharyngeal cancer?
It's a rare type of cancer that starts in the nasopharynx, which is the upper part of your throat, behind your nose.
What is immunotherapy?
Immunotherapy is a type of cancer treatment that helps your body’s own immune system fight cancer cells.
What is a 'Phase 2' trial?
A Phase 2 trial is an early stage of research that checks if a new treatment is safe and if it shows encouraging signs of working for a specific condition.
How long will I be on the treatment?
Treatment duration depends on how your body responds and how well you tolerate the drugs. You will continue as long as the treatment is helping and you're not experiencing severe side effects.
Will I know if I'm getting the new drug or not?
Patients in this study receive either nivolumab alone or nivolumab with relatlimab. Your doctor will discuss with you what you would receive based on the study design.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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