Clinical trial: NCT03921073
Section: Confidentiality
Subsections: Consent For Optional Future Use Of Samples

You are also being asked to allow the use of your samples for future research as described above.  
You may decide not to allow the use of your samples for the optional future research. If you decide not to participate, your decision will have no impact on your ability to participate in the main study and will have no impact on any other benefits to which you would otherwise be entitled.  
Please indicate your preference below:  
(initials) I agree to allow the use of my samples for future research described above.  
(initials) I do not agree to the use of my samples for future research described ONO above.
Clinical trial: NCT03921073
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Are There Risks To Me If I Am In This Study?|Can Talimogene Laherparepvec Be Spread To My Family Members Or Other Close Contacts And How Long After Study Treatment Is This Possible?|Is There Any Risk To My Family Members Or Other Close Contacts If They Are Exposed To Talimogene Laherparepvec?

Right now, we do not know for sure if talimogene laherparepvec will help.  If it does not help, your condition/disease may get worse.  
.  
You may have problems because of the study drug, talimogene laherparepvec, used in this study.  These problems are called side effects.  Some side effects are just bothersome.  Others could harm you.  There may be some side effects that we do not know about yet.  The research might involve risks to you that are currently unforeseeable.  Your study health care team may give you medicines to help lessen side effects.  Many side effects go away soon after you stop taking the study drug.  In some cases, side effects can be serious, long lasting, or may never go away.  
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There are known side effects of this study on talimogene laherparepvec and its associated procedures.
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Talimogene laherparepvec may cause all, some, or none of the side effects listed below.  
There may also be unknown side effects from taking talimogene laherparepvec alone or with other drugs you may be taking. These side effects can be mild but could also be serious or even result in death. The majority of Amgen research studies with talimogene laherparepvec have been in people with malignant melanoma.

There have been no reported cases of spreading of talimogene laherparepvec to close contacts or family members in clinical trials or during regular treatment to date. However talimogene laherparepvec could potentially be spread to your family members or other close contacts
(household members, caregivers, sex partners, or someone you share a bed with) at any time after your tumor(s) is/are injected with the study drug.  
This may occur if your family member or other close contact touches the injection site or has contact with your body fluids or with the inside of the dressing(s) covering your injection site(s).  
Spreading talimogene laherparepvec may be more likely if your close contact has a break in the skin or mucous membranes that comes into contact with your injection site or your body fluids.  
Your study doctor will give you instructions on proper precautions to take after your injections.  
In participants treated with talimogene laherparepvec in clinical trials, talimogene laherparepvec has been found on the surface of the injected tumors, up to 2 weeks after the injection, but not on the outside of the dressings that covered these injection sites. Small amounts of talimogene laherparepvec have been detected in participants' blood and urine for up to 1 week after injection. A study is ongoing to determine if talimogene laherparepvec can be detected in mucous membranes of the mouth and genitals.

If a close contact has been exposed to talimogene laherparepvec, it is possible that they could develop symptoms of a herpes type infection. However, the chance of this happening is low due to the changes in talimogene laherparepvec that make it different from the naturally occurring herpes simplex virus, but you should know how to recognize these symptoms. Most adults in the general population have been exposed to the naturally occurring herpes simplex (also known as "cold sore") virus (HSV-1). Common signs and symptoms of the naturally occurring herpes simplex virus include:
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. .  
.  
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Sores around the mouth ("cold sore", "fever blister") or the genitals ("genital sore"). Blisters may develop on the fingers, ears or face.  
Infection of the cornea of the eye (keratitis) with eye pain, light sensitivity, discharge from the eyes or blurry vision Abdominal pain and infections, and inflammation inside the abdomen (infrequently).  
Rarely, serious infections of the brain (encephalitis) or spinal cord, causing paralysis
(unable to move) have been reported. Signs may include fever, confusion or other behavior changes, headache, numbness and pain in the legs, constipation, or difficulty with urination.
.  
Life-threatening infections (disseminated herpes) can develop in people with a
weakened immune system.  
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Clinical trial: NCT03921073
Section: Purpose of Research
Subsections: What Is This Study About?

You are being asked to participate in a research study. The purpose of this study is to see if a product called talimogene laherparepvec would be helpful in the treatment of cutaneous angiosarcoma. Talimogene laherparepvec is a modified herpes simplex 1 virus that can destroy cancer cells while leaving normal cells alone. It would be injected directly into the tumor initially 3 weeks apart. Then the remaining injections will be given every 2 weeks directly into the primary tumor only, for up to one year of injections. Talimogene laherparepvec (T-VEC) is currently FDA approved for cutaneous melanoma.  
Talimogene laherparepvec is called the "study drug" in this document. Talimogene laherparepvec is still experimental and has not been approved by any regulatory health agency
(like the Food and Drug Administration [FDA] or European Medicines Agency [EMA]) for use in people with cutaneous angiosarcoma.  
Talimogene laherparepvec is a modified form of herpes simplex virus (HSV) type-1 (the 'cold sore' virus).  The virus' genes were modified in a laboratory so that it produces a protein called human granulocyte macrophage colony-stimulating factor (GM-CSF) and multiplies and grows in tumor cells.  Human GM-CSF is normally produced by various cells within the body and is used as a medicine to treat people with white blood cell counts that are too low.  This modified herpes simplex virus type-1 is not designed to change any of your genes, but instead acts as an agent to act on tumor cells and stimulate your immune system. Talimogene laherparepvec is administered by injection with a needle directly into one or more tumors.  Your study doctor will decide which tumors are injected.  Talimogene laherparepvec is intended to work in two complementary ways: by directly destroying cells in the injected tumors, and by activating the body's own immune cells to destroy the tumor cells throughout the body, not just in the area where it is injected.  
This consent form gives you important information about this study to help you decide if you want to participate. It describes the purpose of this study, the study procedures, the possible risks, and provides information about your rights as a study participant.  
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