The LIGHTBEAM-01A Study is being conducted to learn more about the safetySafe / SafetyAn assessment of the likelihood of causing an undesired effect and effectiveness of the investigational study drug, zilovertamab vedotin, in children and teens with certain blood cancersCancerAbnormal cells that grow out of control [may invade other tissues and may spread into other parts of the body]; Also called malignancy. and solid tumorsTumorA mass or growth that forms in the body that can be cancer (malignant) or not cancer (benign). Also called neoplasm.

Talk to your child’s oncologistOncologistA doctor who diagnoses and cares for people with cancer about the LIGHTBEAM-01A Study. They’ll be able to answer your questions or reach out to a LIGHTBEAM-01A Study doctor to find out more.

Your child must be less than 18 years old (or less than 25 years old if they have Ewing sarcomaEwing sarcomaA type of bone or soft tissue cancer that usually starts in the arms, legs, pelvis) at the time you sign the Informed Consent FormInformed Consent form (IC)A document that provides information about the purpose of the study, possible risks and benefits, and the participant's rights and responsibilities. Signing the consent form means that the person agrees to participate in the research; A document used to explain the details of a study (clinical trial)(the document that shows you agree to your child participating in the study). A child who turns 18 during their participation in the studyClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol; can remain in the study.

All eligible study participantsStudy participantA person in a study will receive the investigational study drugInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied, zilovertamab vedotin.

The investigational study drugInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied is given as an intravenous (IV)Intravenous (IV)Medicine or fluid given through a needle or flexible tube into a vein infusionInfusionA way to deliver fluid into the body [including through a flexible tube into a vein or through the skin]; the fluid could be a study treatment, medicine or other liquids, like saline for hydration; a study treatment given to the participant through a vein every 3 weeks. An IV infusion delivers a liquid medicine directly into a vein using a needle or tube. This allows medicines to be delivered directly into the bloodstream.

There are risks and benefits to being in any clinical studyClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol;, which a study doctor can discuss with you in greater detail. The study doctor and study team will answer any questions you may have and review eligibility criteriaEligibility criteriaA set of requirements (characteristics) used to determine whether a person can enroll in a study [clinical trial]; the reasons a person can be included in, or excluded from a study; used to make sure that a study includes the right participants to help answer the research questions [For example, a study may be looking to include only people of a certain age or with a certain health condition. When all participants meet the same eligibility criteria, it is more likely that results of the study are caused by the intervention being tested and not by other factors or by chance]; See also Inclusion Criteria, Exclusion Criteria to see if your child may be eligible to participate.

As with all medicinesDrug (or medicine, medication, treatment)Medicine being studied in the clinical trial; study medication; study treatment., there is the possibility of side effectsSide effectAn effect of a medicine, treatment or intervention that is additional to the main intended effect and can be good, bad or neutral; A health problem that is likely caused by an approved treatment, which are unwanted or unintended effects of a medicine. Talk to the study doctor for more information on possible side effectsSide effectAn effect of a medicine, treatment or intervention that is additional to the main intended effect and can be good, bad or neutral; A health problem that is likely caused by an approved treatment. Your child’s health will be closely monitored throughout the entire study. Tell the study doctor if you notice any side effects or changes in your child’s health.

Your child may be in the study for up to 5 years. How long your child receives the investigational study drug will depend on how their cancer responds and the tolerabilityTolerability[A measurement of] How well people manage or handle the effects of a medicine, treatment, or vaccine of any side effectsSide effectAn effect of a medicine, treatment or intervention that is additional to the main intended effect and can be good, bad or neutral; A health problem that is likely caused by an approved treatment.

Your child will go to the study site to receive the investigational study drugInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied and have tests every 3 weeks. At the start of the Study Treatment Period, your child will visit the study site more frequently for tests. Your child will have at least 1 visit during the Follow-up Period. If your child’s cancerCancerAbnormal cells that grow out of control [may invade other tissues and may spread into other parts of the body]; Also called malignancy. does not grow while receiving the investigational study drug, your child will have regular visits for imagingImagingIn medicine, a way to take pictures of inside the body, such as x-rays, ultrasound, MRI scans to check on their cancer.

The study team respects and protects your child’s privacy and will not share their information except as required by law, and will store your child’s personal information with codes that do not identify them. The Informed Consent FormInformed Consent form (IC)A document that provides information about the purpose of the study, possible risks and benefits, and the participant's rights and responsibilities. Signing the consent form means that the person agrees to participate in the research; A document used to explain the details of a study (clinical trial) (completed by you prior to participation) will provide more information about how your child’s privacy will be maintained.

Your child’s participation in the research study is entirely voluntary, and you and your child may withdraw for any reason at any time. If you do decide to withdraw early, you will be asked to notify the study team before doing so. Your child will return to the study site at least once to complete a final visit and return any unused drugDrug (or medicine, medication, treatment)Medicine being studied in the clinical trial; study medication; study treatment..

No, your child’s doctor does not have to give permission for them to participate. However, either you or the study doctor, with your permission, may contact your child’s personal doctor to discuss their participation before your child begins, and also to keep their doctor up to date about their progress throughout the study.

If you think the LIGHTBEAM-01A Study could be a good fit for your child, the next step is to see if your child is eligible. If your child is eligible and
chooses to participate, the study staff will be available to answer any questions you may have. For more answers to your questions, visit:
https://www.merckclinicaltrials.com/faq/.

A research studyClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol;, also known as a clinical trial, tries to answer questions about how medicines work in the people who take them. Researchers run studies to test whether an investigational medicineInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied is safeSafe / SafetyAn assessment of the likelihood of causing an undesired effect and effective. These studies may help doctors find new ways to help prevent, detect, or treat health problems.

ParticipantParticipantPerson; people in a clinical trial. safetySafe / SafetyAn assessment of the likelihood of causing an undesired effect is the priority. There are rules in place to help protect the rights, safety, and well-being of people who volunteer for research studies. These rules are put in place to make sure research studiesClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol; follow strict scientific and ethical guidelines.

Before a research studyClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol; can begin, a review board or ethics committee must review the study. In the US, this group is called an IRB or institutional review boardInstitutional Review Board (IRB)(In US): A team of people who review studies to protect the rights and welfare of study participants; A group formally designated and responsible for reviewing study proposals, monitoring studies involving people and protecting the rights and welfare of study participants. An IRB is made up of doctors, scientists, and members of the community.

Only people who meet all eligibility criteriaEligibility criteriaA set of requirements (characteristics) used to determine whether a person can enroll in a study [clinical trial]; the reasons a person can be included in, or excluded from a study; used to make sure that a study includes the right participants to help answer the research questions [For example, a study may be looking to include only people of a certain age or with a certain health condition. When all participants meet the same eligibility criteria, it is more likely that results of the study are caused by the intervention being tested and not by other factors or by chance]; See also Inclusion Criteria, Exclusion Criteria for a research study may take part. The study team at the site you select will review your child’s medical history and current medical status against the eligibility criteria. They will determine if your child is eligible to participate. You may also be asked to provide information from your child’s medical records to help the study team determine whether your child may be eligible.

An investigational drugInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied is a drug that hasn’t yet been approved for use in the general public. In order to be approved, the investigational drug must be tested in research studies to see if it is safeSafe / SafetyAn assessment of the likelihood of causing an undesired effect and effective for treating the target disease in certain groups of people.

The investigational drug in the LIGHTBEAM-01A Study is being tested in children and teens with certain blood cancersCancerAbnormal cells that grow out of control [may invade other tissues and may spread into other parts of the body]; Also called malignancy. and solid tumorsTumorA mass or growth that forms in the body that can be cancer (malignant) or not cancer (benign). Also called neoplasm to see if it can shrink the cancer or prevent it from growing.