Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
This study, called LIGHTBEAM-U01, is looking at a new treatment called Zilovertamab Vedotin for young patients with specific types of cancer. It includes children and young adults between 6 months and 25 years old. The cancers being studied are B-cell acute lymphoblastic leukaemia, diffuse large B-cell lymphoma, Burkitt lymphoma, neuroblastoma, and Ewing sarcoma. These are all conditions where the cancer has either returned after initial treatment or hasn't responded well to other therapies. The main goals are to see how safe the new drug is and how well it works in treating these cancers. This research is important for finding new ways to help young people battling these difficult diseases.
At a glance
What is this study about?
This study is investigating a new medication called Zilovertamab Vedotin. It's designed for young patients – specifically children and young adults from 6 months up to 25 years old – who are facing certain types of cancer. These include blood cancers like B-cell acute lymphoblastic leukaemia and specific lymphomas (diffuse large B-cell lymphoma and Burkitt lymphoma), as well as solid tumours such as neuroblastoma and Ewing sarcoma. The key focus is on patients whose cancer has either come back after previous treatment or hasn't responded well to other therapies.
The main purpose of this research is twofold: first, to understand how safe Zilovertamab Vedotin is for these young patients, and second, to see how effective it is in treating their specific cancer types. This is a crucial step in developing new treatments, especially for conditions where current options are limited or have not worked. By participating, patients could contribute valuable information that helps medical science advance.
This study is structured in two stages, known as Phase 1 and Phase 2. Phase 1 usually focuses more on finding the right dose and checking for safety, while Phase 2 looks further into how well the treatment works. The information gathered from this study will help researchers understand if Zilovertamab Vedotin could become a new treatment option for these young people in the future.
Key takeaways
- A new drug, Zilovertamab Vedotin, is being tested.
- The study is for children and young adults (6 months - 25 years) with specific cancers.
- Cancers include certain leukaemias, lymphomas, neuroblastoma, and Ewing sarcoma.
- It's for cancers that haven't responded well or have come back.
- The study aims to check the treatment's safety and effectiveness.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, participants must be between 6 months and 25 years old. They need to have a confirmed diagnosis of certain blood cancers (like B-precursor B-cell acute lymphoblastic leukaemia or specific types of diffuse large B-cell lymphoma and Burkitt lymphoma) or solid tumours (like neuroblastoma or Ewing sarcoma).
There are also some reasons why someone might not be able to join. For example, if they have had an organ transplant, a serious heart condition, severe liver disease, or certain nerve problems (like ongoing peripheral neuropathy or Charcot-Marie-Tooth disease). Individuals with Down syndrome or active graft-versus-host disease (GVHD) would also not be eligible.
Other reasons for not being able to take part include having HIV, an allergy to any part of the study drug, or recent treatments like radiotherapy within the past four weeks (until all side effects have cleared). Certain other medications, like high doses of steroids or specific strong drugs that affect liver enzymes, could also prevent participation. Recent live vaccinations or other anti-cancer treatments within the last four weeks would also make someone ineligible.
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 between 6 months and 25 years old?
- Do you have a diagnosis of B-cell acute lymphoblastic leukaemia, diffuse large B-cell lymphoma, Burkitt lymphoma, neuroblastoma, or Ewing sarcoma?
- Has your cancer come back or not responded to previous treatments?
- Do you have any significant heart, liver, or nerve conditions?
- Have you had radiotherapy or certain other cancer treatments recently (within the last 4 weeks)?
- Are you currently on high doses of steroids or specific other medications?
What does participation involve?
The study involves receiving the investigational medication, Zilovertamab Vedotin. The exact schedule of visits and assessments would be fully explained by the study team. This would typically include regular check-ups, blood tests, and scans to monitor your health and how the treatment is working. You would need to inform the study team about all medications you are taking and any symptoms you experience. The total duration of participation would be outlined by the study team, including how long you would receive the treatment and any follow-up appointments after that.
Potential risks and benefits
Locations (69)
- Children's Hospital Los Angeles ( Site 1006)Verified postcodeLos Angeles, United States· Recruiting
- Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)Verified postcodeAurora, United States· Recruiting
- Yale New Haven Hospital ( Site 1012)Verified postcodeNew Haven, United States· Recruiting
- Johns Hopkins All Children's Hospital ( Site 1025)Verified postcodeSt. Petersburg, United States· Recruiting
- University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)Verified postcodeIowa City, United States· Recruiting
- Dana-Farber Cancer Institute ( Site 1013)Verified postcodeBoston, United States· Recruiting
- Corewell Health ( Site 1001)Verified postcodeGrand Rapids, United States· Recruiting
- Children's Mercy Hospital ( Site 1024)Verified postcodeKansas City, United States· Recruiting
- Rutgers Cancer Institute of New Jersey ( Site 1008)Verified postcodeNew Brunswick, United States· Recruiting
- Memorial Sloan Kettering Cancer Center ( Site 1010)Verified postcodeNew York, United States· Recruiting
- New York Medical College ( Site 1023)Verified postcodeValhalla, United States· Recruiting
- Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)Verified postcodeFargo, United States· Recruiting
Common questions
What is Zilovertamab Vedotin?
It's a new medication being tested in this study to treat certain types of cancer in young patients.
What types of cancer is this study looking at?
It's for specific blood cancers (like certain leukaemias and lymphomas) and solid tumours (like neuroblastoma and Ewing sarcoma) that have come back or not responded to other treatments.
Who can take part in this study?
Children and young adults aged between 6 months and 25 years with one of the specific cancer types mentioned, and who meet other health requirements.
What is a Phase 1/Phase 2 study?
Phase 1 studies primarily check a drug's safety and find the right dose. Phase 2 studies then investigate how well the drug works.
Will I still get my usual cancer care if I join the study?
The study treatment is given as part of your care, and the study team will ensure you understand how it fits with your overall treatment plan before you decide to participate.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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