A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
This research study is investigating a new drug called epcoritamab for adults with a type of cancer called Non-Hodgkin Lymphoma. Epcoritamab is given as an injection under the skin and is being tested in combination with several other cancer medicines. The main goals are to find out how safe these drug combinations are and if they help to reduce the cancer activity. This study involves about 496 adults globally, and participants will be placed into different groups, each receiving a specific combination of treatments. Researchers will closely monitor for any side effects and see how the disease responds to the treatment. This study hopes to find better ways to treat Non-Hodgkin Lymphoma.
At a glance
What is this study about?
This study is about a new way to treat Non-Hodgkin Lymphoma, which is a type of cancer that affects certain immune cells called white blood cells, normally responsible for fighting infections. Researchers are testing a new medicine called epcoritamab. This drug is given as an injection just under the skin. They want to see how well it works and how safe it is when combined with other medicines that are already used to treat cancer.
The main aim is to understand if these combinations cause any unwanted side effects and if they can help slow down or reduce the cancer. The study will separate participants into different groups. Each group will receive a specific mix of epcoritamab and other anti-cancer drugs. This will help doctors learn which combinations are most effective and safe. By doing this research, doctors hope to discover better treatment options for people living with Non-Hodgkin Lymphoma.
About 496 adults with Non-Hodgkin Lymphoma from around the world are expected to join this study. Participants will have regular check-ups at a hospital or clinic to monitor their health and the effects of the treatment. This careful monitoring helps researchers gather important information about how the new treatment is working and if there are any issues.
Key takeaways
- This study is testing a new drug, epcoritamab, for Non-Hodgkin Lymphoma.
- Epcoritamab is given as an injection under the skin and combined with other cancer medicines.
- The main goals are to check the treatment's safety and how well it reduces the cancer.
- Around 496 adults will participate in the study globally.
- Participants will have regular clinic visits for physical exams, blood tests, and to report side effects.
- Being part of the study might involve more frequent appointments than usual care.
Who may be eligible?
To be considered for this study, you must be an adult with a specific type of Non-Hodgkin Lymphoma. This includes certain kinds of Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma, or Mantle Cell Lymphoma. Doctors will need to confirm your cancer diagnosis with special tests, including checking for a protein called CD20 and making sure your cancer can be measured.
You also need to be generally well enough to participate in the study, which means you should be able to do most of your daily activities. For most parts of the study, you must have at least one area of cancer that doctors can measure on a scan. Some specific parts of the study might have slight differences in these requirements.
However, you cannot join if you have already received epcoritamab or a similar type of drug called a bispecific antibody. Also, any side effects from previous cancer treatments must have mostly cleared up and not be severe. The study team will review all your medical information carefully to see if this study is right for 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.
- Are you an adult aged 18 years or older?
- Have you been diagnosed with a specific type of Non-Hodgkin Lymphoma (DLBCL, Follicular Lymphoma, or Mantle Cell Lymphoma)?
- Have you NOT previously received epcoritamab or similar 'bispecific antibody' drugs?
- Are any side effects from your past cancer treatments mostly gone or not serious?
- Do you have at least one measurable area of cancer that doctors can see on scans?
What does participation involve?
If you join this study, you will receive epcoritamab as an injection under your skin, combined with other cancer medications which might be taken by mouth or given through a drip (intravenously). The treatment cycles will typically last for 28, 21, or 56 days, depending on which group you are in. You will have regular visits to an approved hospital or clinic throughout the study.
During these visits, the study team will closely monitor your health. This will involve medical check-ups, taking blood samples, and filling out questionnaires to understand how you are feeling. They will also keep a close eye on any side effects you might experience and how your cancer is responding to the treatment. This level of checking is more frequent than what you might typically experience with standard care. The total duration of your participation will depend on your individual response and the study's design.
Potential risks and benefits
Locations (76)
- The University of Arizona Cancer Center - North Campus /ID# 242219Verified postcodeTucson, United States· Completed
- Yale University School of Medicine /ID# 242089Verified postcodeNew Haven, United States· Recruiting
- Christiana Care Health Service /ID# 242301Verified postcodeNewark, United States· Recruiting
- Tampa General Hospital /ID# 246748Verified postcodeTampa, United States· Recruiting
- Winship Cancer Institute of Emory University /ID# 242153Verified postcodeAtlanta, United States· Completed
- University of Maryland, Baltimore /ID# 242218Verified postcodeBaltimore, United States· Recruiting
- Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144Verified postcodeKansas City, United States· Completed
- Northwell Health - Monter Cancer Center /ID# 245435Verified postcodeLake Success, United States· Recruiting
- Icahn School of Medicine at Mount Sinai /ID# 242123Verified postcodeNew York, United States· Recruiting
- Novant Health Presbyterian Medical Center /ID# 242148Verified postcodeCharlotte, United States· Completed
- East Carolina University - Brody School of Medicine /ID# 242506Verified postcodeGreenville, United States· Recruiting
- Novant Health Forsyth Medical Center /ID# 242198Verified postcodeWinston-Salem, United States· Completed
Common questions
What is Non-Hodgkin Lymphoma?
Non-Hodgkin Lymphoma is a type of cancer that starts in white blood cells (lymphocytes), which are part of your immune system.
What is epcoritamab?
Epcoritamab is a new drug being tested for Non-Hodgkin Lymphoma. It's given as an injection under the skin.
Will I get epcoritamab by itself?
No, in this study, epcoritamab is always given in combination with other anti-cancer medications, not by itself.
How often will I have to visit the clinic?
You will have regular visits to an approved hospital or clinic, which might be more often than you'd expect with standard care, for check-ups and monitoring.
Can I stop participating in the study if I want to?
Yes, you have the right to withdraw from the study at any time, for any reason, without impacting your future medical care.
How to find out more
ABBVIE CALL CENTER
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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