Clinical trial: NCT02126579
Section: Alternatives
Subsections: What are your other choices if you do not join this study?|What are your other choices if you do not join this study?

You do not have to be in this study to be treated for your illness or condition. You can get the usual
treatment even if you choose not to be in this study. The usual treatment for patients who have had
complete surgical removal of their melanomas may include:  
interferon alpha therapy
Ipilimumab (YervoyTM)  
interferon alpha therapy  
Ipilimumab (YervoyTM)

IRB 15931: PHASE I/II TRIAL OF A LONG PEPTIDE VACCINE (LPV7) PLUS TLR AGONISTS FOR RESECTED
STAGE IIB - IV MELANOMA  
Part 2  
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radiation therapy
other clinical trials  
radiation therapy  
other clinical trials  
However, you cannot receive these treatments while you are on this trial. This will be discussed by
your physician.  
The FDA has approved high-dose interferon therapy and Ipilimumab (YervoyTM) for the treatment of
some melanomas. The potential benefits and side effects of interferon and Ipilimumab should have
been explained to you. If this has not been explained and offered to you, please ask the study doctor.  
If you are an employee of UVa your job will not be affected if you decide not to participate in this study.
If you are a student at UVa, your grades will not be affected if you decide not to participate in this study.
Clinical trial: NCT02126579
Section: Confidentiality
Subsections: What will happen if you are in the study?|How Will Your Sample(s) Be Labeled?|How Will Your Sample(s) Be Stored and Labeled for Specimen Banking|Which researchers can use your samples and what information about you can they have?|Will You Find Out the Results of the Future Research on Your Sample(s) for Specimen Banking?|Risks of photograph|If you sign this form, we may collect any or all of the following information about you:|Who will see your private information?|What if you sign the form but then decide you don't want your private information shared?|Notification of My Health Care Provider

NOTE: Throughout the study, results of tests and procedures completed as part of your clinical care
will also be recorded for research purposes.

The University of Virginia Human Immune Therapy Center will be responsible for storing your sample
and for protecting your privacy.  
Your sample(s) will not be labeled with your name or other information that would identify you directly.
Instead, your sample will have a unique code that allows for it to be linked to some of your health
information. This link means that your specimen can be identified but only indirectly. We can find out if
we need to know which sample is yours in the event you wish the sample to be removed at a later date.

Dr. Slingluff, the Director of the University of Virginia Human Immune Therapy Center, will be
responsible for storing your sample and for protecting your privacy.  
This research specimen bank is located at the University of Virginia under the leadership of Dr.
Slingluff. There is no set limit to the number of people who will provide samples to this bank.  
Your sample(s) will not be labeled with your name or other information that would identify you directly.
Instead, it will have a unique code that allows for it to be linked to some of your health information. This
link means that your specimen can be identified but only indirectly. We can find out if we need to know
which sample is yours in the event you wish the sample to be removed from the bank later.

Your sample may be shared with researchers at the University of Virginia and at other institutions. Dr.
Slingluff will not give your name to other researchers who want to use your sample, but will only give
them information like your age and what disease/condition you have. Those who would see the
information would include researchers and the others listed under "Who will see your private
information?" section of this consent document.  
Some of the people who receive your information may not have to follow the privacy laws and may
share or release your information because they do not have to follow the privacy laws.

Neither you, your health care provider, nor anyone in your family, will receive the results of any
additional research done on your sample(s). The results will not be put in your health records.
Therefore, results from any research done on your sample(s) will not affect your medical care. This
helps protect you and other members of your family from harm that might be caused by this
information.

Photographs may be taken of your vaccine site, your biopsy sites or of any lesions that you develop on
your skin. Most photographs will not include your face, unless including your face in the photograph is
unavoidable (for example, you have a tumor on your head). Although it is highly unlikely that anyone
could identify you from the photograph, this is still a risk should your lesion is on or near your face. To
reduce this risk, only the portion of the face that has the area of interest will be photographed. If the
photograph does include your face, your identifying features (eyes, nose, mouth, etc.) will be blacked
out. Care will be taken to obtain the photo in such a manner that you cannot be identified. All
photographs will be kept on a secure computer database and in your study chart. Further, only
authorized individuals will have access to the photograph.

Personal information such as name, address and date of birth
Social Security number ONLY IF you are being paid to be in this study
Your health information if required for this study. This may include a review of your medical records
and test results from before, during and after the study from any of your doctors or health care
providers. This may include mental health care records, substance abuse records, and/or
HIV/AIDS records.
Tissue or blood samples if you agree to provide them for genetic testing for this study  
Personal information such as name, address and date of birth  
Social Security number ONLY IF you are being paid to be in this study  
Your health information if required for this study. This may include a review of your medical records
and test results from before, during and after the study from any of your doctors or health care
providers. This may include mental health care records, substance abuse records, and/or
HIV/AIDS records.  
Tissue or blood samples if you agree to provide them for genetic testing for this study

0100000  
People or groups that oversee the study to make sure it is done correctly
The sponsor(s) of this study, and the people or groups it hires to help perform or review this
research
Insurance companies or other organizations that may need the information in order to pay your
medical bills or other costs of your participation in the study
Tax reporting offices (if you are paid for being in the study)
People who evaluate study results, which can include sponsors and other companies that make the
drug or device being studied, researchers at other sites conducting the same study, and
government agencies that provide oversight such as the Food and Drug Administration (FDA) if the
study is regulated by the FDA.
If you tell us that someone is hurting you, or that you might hurt yourself or someone else, the law
may require us to let people in authority know so they can protect you and others.  
People or groups that oversee the study to make sure it is done correctly  
The sponsor(s) of this study, and the people or groups it hires to help perform or review this
research  
Insurance companies or other organizations that may need the information in order to pay your
medical bills or other costs of your participation in the study  
Tax reporting offices (if you are paid for being in the study)  
People who evaluate study results, which can include sponsors and other companies that make the
drug or device being studied, researchers at other sites conducting the same study, and
government agencies that provide oversight such as the Food and Drug Administration (FDA) if the
study is regulated by the FDA.  
If you tell us that someone is hurting you, or that you might hurt yourself or someone else, the law
may require us to let people in authority know so they can protect you and others.  
Some of the people outside of UVa who will see your information may not have to follow the same
privacy laws that we follow. They may release your information to others, and it may no longer be
protected by those laws.  
The information collected from you might be published in a medical journal. This would be done in a
way that protects your privacy. No one will be able to find out from the article that you were in the
study.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S.
Law. This Web site will not include information that can identify you. At most, the Web site will include a
summary of the results. You can search this Web site at any time.

IRB 15931: PHASE I/II TRIAL OF A LONG PEPTIDE VACCINE (LPV7) PLUS TLR AGONISTS FOR RESECTED
STAGE IIB - IV MELANOMA  
Part 2  
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In addition, the Certificate does not prevent government authorities who oversee research from
reviewing this study. This Certificate does not mean that the government either approves or
disapproves of this study. It just helps protect your privacy.

Your health care provider will be notified of your participation in this study.
Clinical trial: NCT02126579
Section: Duration of Study Involvement
Subsections: How long will this study take?|Annual Follow Up Phone Calls

Your participation in this study will require 13 study visits over 2 years. Each visit will be as an out-
patient and last about 2-5 hours, and possibly more. In addition, we will contact you about once per
year for follow-up purposes to find out how you are doing.

We would like to keep track of your medical condition for the rest of your life. We would like to do this
by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and
checking on your condition every year helps us look at the long-term effects of the study.
Clinical trial: NCT02126579
Section: Participant Responsibilities
Subsections: What are your responsibilities in the study?

You have certain responsibilities to help ensure your safety.
These responsibilities are listed below:  
You must be completely truthful about your health history.
Follow all instructions given.
You should tell the study doctor or study staff about any changes in your health or the way you
feel.
Answer all of the study-related questions completely.
Inform the study doctor or study staff as soon as possible if you have to take any new
medications, including anything prescribed by a doctor or those that you can buy without a
prescription (over-the-counter), including herbal supplements and vitamins. The study doctor
will let you know if you can take these medications.  
You must be completely truthful about your health history.  
Follow all instructions given.  
You should tell the study doctor or study staff about any changes in your health or the way you
feel.  
Answer all of the study-related questions completely.  
Inform the study doctor or study staff as soon as possible if you have to take any new
medications, including anything prescribed by a doctor or those that you can buy without a
prescription (over-the-counter), including herbal supplements and vitamins. The study doctor
will let you know if you can take these medications.
Clinical trial: NCT02126579
Section: Participant's Rights
Subsections: Will You Find Out the Results of the HLA testing?|Please contact the researchers listed below to:|What if you have a concern about this study?|Consent From Adult|Person Obtaining Consent|Interpreter|Consent from Impartial Witness|Consent From Adult|Person Obtaining Consent|Interpreter

You will have the option to receive or not receive your HLA results from the UVA research team.

Obtain more information about the study
Ask a question about the study procedures or treatments
Report an illness, injury, or other problem (you may also need to tell your regular doctors)
Leave the study before it is finished
Express a concern about the study
Craig L. Slingluff, M.D.
University of Virginia Health System
Human Immune Therapy Center
Box 801457
Charlottesville, VA 22908
Telephone: 434-924-9311  
Obtain more information about the study  
Ask a question about the study procedures or treatments  
Report an illness, injury, or other problem (you may also need to tell your regular doctors)  
Leave the study before it is finished  
Express a concern about the study  
Craig L. Slingluff, M.D.
University of Virginia Health System
Human Immune Therapy Center
Box 801457
Charlottesville, VA 22908
Telephone: 434-924-9311

You may also report a concern about this study or ask questions about your rights as a research
subject by contacting the Institutional Review Board listed below.  
University of Virginia Institutional Review Board for Health Sciences Research
PO Box 800483
Charlottesville, Virginia 22908
Telephone: 434-924-9634  
University of Virginia Institutional Review Board for Health Sciences Research
PO Box 800483  
Charlottesville, Virginia 22908  
Telephone: 434-924-9634  
When you call or write about a concern, please give as much information as you can. Include the name
of the study leader, the IRB-HSR Number (at the top of this form), and details about the problem. This
will help officials look into your concern. When reporting a concern, you do not have to give your name.

PARTICIPANT  
PARTICIPANT  
(SIGNATURE)  
(PRINT)  
To be completed by participant if 18 years of age or older.  
DATE  
If an interpreter is involved in the consent process because the potential subject does not speak English
well or at all, the participant should NOT sign on the line above I leave this line blank. Instead, the
participant should sign the Short Form or full consent written in the language they can understand.

By signing below you confirm that you have fully explained this study to the potential subject, allowed
them time to read the consent or have the consent read to them, and have answered all their questions.  
PERSON OBTAINING CONSENT
(SIGNATURE)  
PERSON OBTAINING CONSENT
(PRINT)  
DATE

By signing below you confirm that the study has been fully explained to the potential subject in a
language they understand and have answered all their questions.  
If an interpreter was used to explain this study to a potential subject, the interpreter must sign
and date the line above.

If this consent form is read to the subject because the subject is blind or illiterate, an impartial
witness not affiliated with the research or study doctor must be present for the consenting
process and sign the following statement. The subject may place an X on the Participant
Signature line above.  
I agree the information in this informed consent form was presented orally in my presence to the
identified individual(s) who has had the opportunity to ask any questions he/she had about the
study. I also agree that the identified individual(s) freely gave their informed consent to participate in
this trial.  
Please indicate with check box the identified individual(s):
Subject
IMPARTIAL WITNESS
IMPARTIAL WITNESS
DATE
(SIGNATURE)
(PRINT)

PARTICIPANT
PARTICIPANT
(SIGNATURE)
(PRINT)  
DATE  
To be completed by participant if 18 years of age or older.  
If an interpreter is involved in the consent process because the potential subject does not speak English well or at all,
the participant should NOT sign on the line above - leave this line blank. Instead, the participant should sign the
Short Form or full consent written in the language they can understand.

By signing below you confirm that you have fully explained this study to the potential subject, allowed
them time to read the consent or have the consent read to them, and have answered all their questions.  
PERSON OBTAINING CONSENT
(SIGNATURE)  
PERSON OBTAINING CONSENT
(PRINT)  
DATE

By signing below you confirm that the study has been fully explained to the potential subject in a
language they understand and have answered all their questions.  
INTERPRETER
(SIGNATURE)  
INTERPRETER
(PRINT)  
DATE  
If an interpreter was used to explain this study to a potential subject, the interpreter must sign and date the line
above.
Clinical trial: NCT02126579
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Biopsies of Tumor|Risks to Privacy from Future Genetic Research and Specimen Banking:|Risks to Your Job, Insurance or Family Planning,|Risks to Your Job, Insurance or Family Planning,|HLA Test Results|What are the risks of being in this study?|Likely|Less Likely|Less Likely|Rare but Serious|Possible Side effects of study drugs/agents that have not yet been reported by study participants:|Risks and side effects related to the polyICLC|Less Likely|Less Likely|Rare but Serious|Risks and side effects related to the biopsies include:|Rare but serious|Blood Donation|Risks of having your blood drawn:|A caution about giving too much blood:|Risks for women:|Risks for men:|Other unexpected risks:|Could you be helped by being in this study?|What if you are hurt in this study?

During the course of the study, you may have one or more whole tumors reduced in size or removed. This
may be completed as a part of your clinical care or your physician recommends this as part of your clinical
care. You will sign a separate hospital consent describing the risks of this procedure.

The main risk of allowing us to store and use your samples and certain limited health information for
research is a potential loss of privacy. One of the risks to you is the release of information from your
health records. The University of Virginia will do its best to protect your records so that facts about you
and your health will be kept private. The chance that information identifying you will be given to
someone else is very small. However, we cannot guarantee it will be safe. To further safeguard your
privacy, information obtained from future research will not be placed in your medical record.  
There are certain risks of having health information given to other people by mistake. In the unlikely
event that this happens, it could cause discrimination or mental harm to you or your family members if
others were to see this information. The results could be that you may not be able to get or keep
certain kinds of insurance. It could also hurt family relationships.  
Because everyone has unique DNA, it is also possible, although very unlikely, that someone could
identify you through your DNA if they have another sample of your DNA.  
Different types of genetic tests carry different levels of risks. Depending upon the type of genetic
testing that is completed, information about your genetic make-up could mean that you and your family
members may face problems that could lead to getting or keeping some kinds of insurance or affect
your ability to get or keep a job. To keep this from happening, the results of these tests will not be
given to anyone outside of the study staff. There is no way to predict all the possible risks of this
research.

Once you have been told a test result, you may have to reveal the result when you apply for health, life,
disability, or other insurance. This is true whether or not the result is entered into your medical record.
Some insurance companies may consider genetic results in making insurance decisions. They may

decide not to offer coverage, to limit coverage, or to charge a higher premium for coverage. You may
want to review and make any changes in your insurance coverage before testing. However you should
know that the Genetic Information Discrimination Act of 2008, along with other Federal Laws, generally
prohibits health insurers or health plan administrators from requesting or requiring genetic information
of an individual or the individual's family members, or using it for decisions regarding coverage, rates,
or preexisting conditions. The law also prohibits most employers from using genetic information for
hiring, firing, or promotion decisions, and for any decisions regarding terms of employment. However,
this law does not protect your ability to get or keep other kinds of insurance such as life insurance or
long term care insurance.  
You may be encouraged to share information with other family members. But some family members
may not welcome the information. And you may find out some things you didn't want to know as well.
For example, you may learn that a family member is adopted. This may sometimes cause relationships
in families to change. Other members of your family may also learn things about your health or risk of
genetic disease,

If you would like to know the results of your HLA testing, they will be may be shared with you by the
researchers or your doctor. In most cases it is not risky or harmful to know your HLA type. It is
important that you know that sometimes the HLA result might affect your ability to get or keep some
kinds of insurance or it may affect your family relationships. This could make you feel anxious. Also,
keep in mind that if you know your HLA type, you would be required, if asked, to share this information
with your insurance company even if it is not in your medical record. You may wish to discuss the risks
of knowing your HLA type with the researchers or your doctor.  
Sometimes, a test result may show that one or both of a child's parents is not the real birth parent. If
this happens, we will not share this information with anyone, including you. We, the research team,
would only disclose this information if the law said we had to. Your doctor may choose to disclose this
information to you.

Risks and side effects which may occur with the LPV7 vaccine/Montanide include the following. These
risks and side effects are based on results from prior studies conducted by the Human Immune
Therapy using similar types of vaccines:

Loss of red blood cells, also called anemia, can cause tiredness, weakness and
shortness of breath
Fatigue (feeling tired)
Fever
Chills
Sweating
Flushing
Local pain, bleeding, bruising at the injection site
Redness, itching, and swelling at the injection site
Rash
Loss of appetite
Diarrhea
Nausea
Small changes in the levels of sugar in your blood (hyperglycemia), which may make
you feel thirsty or tired.
Dizziness
Headache
Pain in your joints
Pain in your muscles
Cough  
Loss of red blood cells, also called anemia, can cause tiredness, weakness and
shortness of breath  
Fatigue (feeling tired)  
Fever  
Chills  
Sweating  
Flushing  
Local pain, bleeding, bruising at the injection site  
Redness, itching, and swelling at the injection site  
Rash  
Loss of appetite  
Diarrhea  
Nausea  
Small changes in the levels of sugar in your blood (hyperglycemia), which may make
you feel thirsty or tired.  
Dizziness  
Headache  
Pain in your joints  
Pain in your muscles  
Cough

Autoimmune disease (immune reactivity against your own cells). These usually are limited to
loss of some pigmented skin cells, and to changes in blood tests but without symptoms.
However, a severe autoimmune reaction could lead to death. Examples of autoimmune
diseases in humans are lupus and rheumatoid arthritis.
Runny nose
Lowering of your white blood cell counts, which if serious may make you more susceptible to
infection
Loss of skin pigment (may happen anywhere on your body). This is called Vitiligo.
Itching
An open sore (ulceration) at the injection site
Hives
Constipation
Inflammation in the mouth
Vomiting
Swelling in different parts of your body
You may feel bloated, tired, weak, or thirsty
You may feel sweaty, hungry, dizzy, weak, shaky, or have a racing and/or pounding heart beat
You may feel anxious, agitated, or depressed
Throat pain  
Autoimmune disease (immune reactivity against your own cells). These usually are limited to
loss of some pigmented skin cells, and to changes in blood tests but without symptoms.
However, a severe autoimmune reaction could lead to death. Examples of autoimmune
diseases in humans are lupus and rheumatoid arthritis.  
Runny nose  
Lowering of your white blood cell counts, which if serious may make you more susceptible to
infection  
Loss of skin pigment (may happen anywhere on your body). This is called Vitiligo.  
Itching  
An open sore (ulceration) at the injection site  
Hives  
Constipation  
Inflammation in the mouth  
Vomiting  
Swelling in different parts of your body  
You may feel bloated, tired, weak, or thirsty  
You may feel sweaty, hungry, dizzy, weak, shaky, or have a racing and/or pounding heart beat  
You may feel anxious, agitated, or depressed  
Throat pain

0
o  
Stuffy nose/nasal congestion
Inflammation or increased fluid in the lungs that may make you cough, have a fever, feel tired
and short of breath (serious). If you have these symptoms, you may be asked to have a chest X-
ray.
Changes in your voice
Flu-like symptoms  
Stuffy nose/nasal congestion  
Inflammation or increased fluid in the lungs that may make you cough, have a fever, feel tired
and short of breath (serious). If you have these symptoms, you may be asked to have a chest X-
ray.  
Changes in your voice  
Flu-like symptoms

Infection requiring treatment
These are rare but serious theoretical risks, meaning they have not been seen in any subjects in
the UVA HITC peptide vaccine studies,
Visual changes (blurred vision, flashing lights, floaters, or night blindness).
If you experience any changes in vision during or after this study, please contact
a study doctor, nurse, or physician assistant immediately.
These symptoms could mean you are developing a condition called retinopathy
or papilledema of the eye. If left untreated, these conditions can result in
blindness. With proper treatment and management, the risks noted above are
usually temporary conditions  
Infection requiring treatment  
These are rare but serious theoretical risks, meaning they have not been seen in any subjects in
the UVA HITC peptide vaccine studies,  
Visual changes (blurred vision, flashing lights, floaters, or night blindness).  
If you experience any changes in vision during or after this study, please contact
a study doctor, nurse, or physician assistant immediately.  
These symptoms could mean you are developing a condition called retinopathy
or papilledema of the eye. If left untreated, these conditions can result in
blindness. With proper treatment and management, the risks noted above are
usually temporary conditions

The adjuvant Montanide ISA-51 has been used in a number of human clinical trials with little or no
toxicity observed. The possible side effects of receiving Montanide adjuvant include a major allergic
reaction (anaphylaxis) to one of the vaccine ingredients (rare). Such a reaction might include hives,
rash, generalized swelling of the body, low blood pressure, difficulty breathing, and abdominal pain, and
possibly death. Anaphylaxis, if it occurs is usually treatable. Thus, we are asking you to remain in the
clinic for a period of time after receiving the vaccine so that we may treat you if anaphylaxis occurs.

Likely  
Fatigue
Fever
Nausea
Redness, itching, swelling, pain at the injection site
Headache
Body aches (may include muscle pain or joint pain)  
Fatigue  
Fever  
Nausea  
Redness, itching, swelling, pain at the injection site  
Headache  
Body aches (may include muscle pain or joint pain)

Chills
Tremors
An increase in liver proteins which may indicate that your liver cells are inflamed or damaged in
some way. This may cause your skin, the white part of your eyes, and the inside of your mouth  
Chills  
Tremors  
An increase in liver proteins which may indicate that your liver cells are inflamed or damaged in
some way. This may cause your skin, the white part of your eyes, and the inside of your mouth

0100000  
to turn yellow. You may also feel tired, your skin may itch, your legs and feet may swell and
you may have some pain in your stomach.  
Rash
Bruising at the injection site
An open sore (ulceration) and/or hardening of the skin (induration) at the injection site
Dry skin
Hives
Lowering of your white blood cell counts, which if serious may make you more susceptible to
infection
Lowering of your platelet counts, which if serious may make you more susceptible to bleeding
Loss of red blood cells, also called anemia, can cause tiredness, weakness and shortness of
breath
Runny nose
Difficulty sleeping
Vomiting
Dizziness  
Rash  
Bruising at the injection site  
An open sore (ulceration) and/or hardening of the skin (induration) at the injection site  
Dry skin  
Hives  
Lowering of your white blood cell counts, which if serious may make you more susceptible to
infection  
Lowering of your platelet counts, which if serious may make you more susceptible to bleeding  
Loss of red blood cells, also called anemia, can cause tiredness, weakness and shortness of
breath  
Runny nose  
Difficulty sleeping  
Vomiting  
Dizziness

Your muscles may feel weak
Inflammation or increased fluid in the lungs that may make you cough, have a fever, feel tired
and short of breath (serious). If you have these symptoms, you may be asked to have a chest X-
ray.
The levels of oxygen in your body may be reduced. As a result, it may be difficult to breath, you
may get a headache or feel nauseous, your skin may turn blue, and you may be tired. In severe
cases, reduced oxygen levels may cause you to have seizures, may cause you to go into a
coma and may cause death.
Sodium-serum high. You may have excessive thirst, lethargy, weakness, irritability, and
swelling due to increased sodium in your blood. This generally is easily corrected. With more
severe elevations of the sodium level, seizures and coma may occur.  
Your muscles may feel weak  
Inflammation or increased fluid in the lungs that may make you cough, have a fever, feel tired
and short of breath (serious). If you have these symptoms, you may be asked to have a chest X-
ray.  
The levels of oxygen in your body may be reduced. As a result, it may be difficult to breath, you
may get a headache or feel nauseous, your skin may turn blue, and you may be tired. In severe
cases, reduced oxygen levels may cause you to have seizures, may cause you to go into a
coma and may cause death.  
Sodium-serum high. You may have excessive thirst, lethargy, weakness, irritability, and
swelling due to increased sodium in your blood. This generally is easily corrected. With more
severe elevations of the sodium level, seizures and coma may occur.  
With proper treatment and management, the risks noted above are usually temporary conditions.

Likely  
Discomfort from insertion of the needle for local anesthetic
Scar at the biopsy site
Mild discomfort at the biopsy site
Numbness at the biopsy site
Bleeding at the biopsy site
Small wound which may take a few weeks to heal  
Discomfort from insertion of the needle for local anesthetic  
Scar at the biopsy site  
Mild discomfort at the biopsy site  
Numbness at the biopsy site  
Bleeding at the biopsy site  
Small wound which may take a few weeks to heal

Infection at the biopsy site

If you participate in this study it may affect your ability to donate blood. If you have any questions call
the organization where you donate blood and talk to one of their nurses.

Having blood drawn may cause:  
pain (common),
a bruise (sometimes),
fainting or passing out (not very often), and
infection (rare).  
pain (common),  
a bruise (sometimes),  
fainting or passing out (not very often), and  
infection (rare).  
If the people doing the study are exposed to your blood or body fluids in a way that could give them a
disease, your blood may be tested. The tests might check for:  
hepatitis,
HIV (Human Immunodeficiency Virus), or
other infections.  
hepatitis,  
HIV (Human Immunodeficiency Virus), or  
other infections.  
You and the person exposed would be told the test results. However, your name would be kept private.
If your test is positive for hepatitis or HIV or any other infection that may affect your clinical care, we will
tell you the results and help you understand what the results mean for you.

Because of the amount of blood being taken, you should not give blood for other reasons until the study
is complete. For example, avoid giving blood at a blood bank or in another research study.

Pregnancy and Contraception  
The drug(s) used in this study can harm an unborn or nursing baby. Therefore, you cannot be in this
study if you are pregnant or nursing a baby. A pregnancy blood test will be done about 2 weeks before
starting this study if you are a woman able to become pregnant. You MUST NOT become pregnant
while on this study or for up to 30 days after the study is over.  
You and your partner must use an approved form of birth control during this study. Examples of birth
control you may use are:

We also do not know the effects of these drugs on male sperm. If you are a male, you should not
father a baby while you are in this study or for 30 days after the study ends. You should also not donate
to a sperm bank during this time. To do so may hurt your unborn baby. Use an effective method of
birth control during this time. Effective forms of birth control are listed above.  
If your partner becomes pregnant during this study, you must tell your doctor right away. The study
team will ask to contact her to obtain her consent to obtain information about the baby after it is born.

You may have side effects that we do not expect or know to watch for now. Call the study leader if you
have any symptoms or problems.

You may or may not benefit from being in this study. Possible benefits include developing an immune
response against the peptides and against your tumor, which may lead to the destruction of tumor cells
in your body. We do not know if you will have an immune response following vaccination with the
peptides or the Montanide ISA-51, resiquimod, or polyICLC.  
Further, the information obtained in this study is expected to aid us in the design of improved cancer
vaccines and therefore may benefit future patients or society in general.

You do not give up any legal rights, such as seeking compensation for injury, by signing this form. If
you feel you have been injured as a result of this study you may contact the Principal Investigator or the
IRB (phone numbers are located near the end of this form). If you are hurt as a result of being in this
study, there are no plans to pay you for medical expenses, lost wages, disability, or discomfort. The
charges for any medical treatment you receive will be billed to your insurance. You will be responsible
for any amount your insurance does not cover.
Clinical trial: NCT02126579
Section: Procedures
Subsections: SCREENING (will take approximately 2-5 hours to complete):|SCREENING (will take approximately 2-5 hours to complete):|SCREENING (will take approximately 2-5 hours to complete):|STUDY TREATMENT (Each study visit will take about 2-5 hours)|Day 1, Week 0|Day 8, Week 1|Day 15, Week 2|Day 22, Week 3|Day 22, Week 3|Day 36, Week 5|Day 43, Week 6|Day 43, Week 6|Day 57, Week 8|Day 78, Week 11|Day 78, Week 11|FOLLOW UP:|Day 365, Week 52 and Day 730, Week 104|Additional Tests, Treatments, and/or Procedures|Annual Follow Up Phone Calls|Blood Testing|Blood Testing|If you want to know about the results before the study is done:|Collection of Samples and Health Information for Mandatory HLA typing as part of clinical care and Optional Future Genetic Research and Specimen Banking for Research|What will you have to do to give samples for research?|HLA Testing for clinical care|Risks for women:|Will being in this study cost you any money?|

This study may be introduced to you by one of the members of your clinical team, or another member
of the University of Virginia, such as a member of this study's research team. Before you agree to
participate in this study, you will have an opportunity to review this consent form and to have all of your
questions answered.  
If you agree to participate, you will sign this consent form before any study related procedures take
place. Before you can start in the study, there will be a screening period. You will have tests and
procedures during this time to make sure you are eligible and it is safe for you to participate.  
Further, the study team will want to have access to tests and procedures done prior to this study. The
research team may ask you some questions and/or review your records for information and results, and
may request copies of documents, which will become part of your study records, including the following:  
Your medical history
Results for any test you may have completed for other reasons, including, but not limited to:
Physical exam and vital signs (blood pressure, heart rate, etc.)
Blood tests reports
Other testing reports
CT, MRI, PET scans, or other imaging reports
X-rays
pathology reports
Notes and/or your clinicians may make about your care, and perhaps biopsies or surgeries.  
Your medical history  
Results for any test you may have completed for other reasons, including, but not limited to:  
Physical exam and vital signs (blood pressure, heart rate, etc.)  
Blood tests reports  
Other testing reports  
CT, MRI, PET scans, or other imaging reports  
X-rays  
pathology reports  
Notes and/or your clinicians may make about your care, and perhaps biopsies or surgeries.  
Information will be collected; such as your age, gender, and race. This will be completed as part of
your clinical care and the information will also be used for research.

Your tumor specimen may be reviewed by pathologists at UVA. This would be done to evaluate or
to confirm if you are eligible for this study. However, it also may have clinical value for you, as we
have in the past found that patients thought to have metastasis (spread) of melanoma did not in fact
have that. This will be completed as part of your clinical care.
You will also have a physical exam for clinical purposes to be performed by a study clinician in the
Cancer Center Clinic:
Vital signs (blood pressure, heart rate, temperature, etc.)
Weight
Determining your ability to function and perform daily activities
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading
Determining where on your body the treatment will be given
Medications that you are taking; including any over-the-counter, alternative medications,
herbal medications, or supplements will be recorded.
About 1 to 2 tablespoons of blood will be drawn from a vein in your arm. You may be asked to
avoid food and all liquids except water for 4 hours before the blood draw. (Abnormal tests may
prompt additional clinical evaluation and management for your health.) This blood will be
completed as part of your clinical care and used to:
Perform a genetic test called HLA typing. This test is like typing your blood for donating to
or receiving blood from other people. If you blood cells are a certain type, you may be
eligible to receive the experimental vaccine. If you already know your HLA type, this test will
not be repeated.
Test for HIV and Hepatitis C virus, if you have not had this testing done within the past 6
months. Patients with HIV, Hepatitis C are not believed to be as likely to benefit from study
treatment for their cancer, and/or may be best advised to seek treatment for those viral
illnesses. Test results must be negative in order to participate in this study.
For women: Perform a serum pregnancy test if you can get pregnant and have not had a
test done within the past two weeks. Because the safety of the study drugs to the maturing
fetus has not been evaluated, this test must be negative in order to participate in this study.
Check your blood counts, certain levels of fats, salts, and sugars, kidney and liver function,
and your immune system.
Check your LDH (lactic acid dehydrogenase). LDH is an enzyme in the body that helps
detect tissue or cell breakdown and also can indicate the presence of cancer, meningitis
(inflammation of the thin layers of tissue that cover and protect the brain and spinal cord)
and other disorders.
Check kidney function and liver function.
Your urine will be tested to check your kidney function. This will be completed as part of your
clinical care.
Scans will be performed if you have not completed scan(s) within 6 weeks of enrollment and
randomization in this study. All scans/imaging will be completed as part of your clinical
care.
You will have a CT scan or PET/CT scan (special X-rays) or X-ray of your chest, a CT scan or
PET/CT scan of your abdomen and pelvis, and a magnetic resonance imaging (MRI) scan or CT
scan of your head. Contrast dye may be used for these scans  
Your tumor specimen may be reviewed by pathologists at UVA. This would be done to evaluate or
to confirm if you are eligible for this study. However, it also may have clinical value for you, as we
have in the past found that patients thought to have metastasis (spread) of melanoma did not in fact
have that. This will be completed as part of your clinical care.  
You will also have a physical exam for clinical purposes to be performed by a study clinician in the
Cancer Center Clinic:  
Vital signs (blood pressure, heart rate, temperature, etc.)  
Weight  
Determining your ability to function and perform daily activities  
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading  
Determining where on your body the treatment will be given  
Medications that you are taking; including any over-the-counter, alternative medications,
herbal medications, or supplements will be recorded.  
About 1 to 2 tablespoons of blood will be drawn from a vein in your arm. You may be asked to
avoid food and all liquids except water for 4 hours before the blood draw. (Abnormal tests may
prompt additional clinical evaluation and management for your health.) This blood will be
completed as part of your clinical care and used to:  
Perform a genetic test called HLA typing. This test is like typing your blood for donating to
or receiving blood from other people. If you blood cells are a certain type, you may be
eligible to receive the experimental vaccine. If you already know your HLA type, this test will
not be repeated.  
Test for HIV and Hepatitis C virus, if you have not had this testing done within the past 6
months. Patients with HIV, Hepatitis C are not believed to be as likely to benefit from study
treatment for their cancer, and/or may be best advised to seek treatment for those viral
illnesses. Test results must be negative in order to participate in this study.  
For women: Perform a serum pregnancy test if you can get pregnant and have not had a
test done within the past two weeks. Because the safety of the study drugs to the maturing
fetus has not been evaluated, this test must be negative in order to participate in this study.  
Check your blood counts, certain levels of fats, salts, and sugars, kidney and liver function,
and your immune system.  
Check your LDH (lactic acid dehydrogenase). LDH is an enzyme in the body that helps
detect tissue or cell breakdown and also can indicate the presence of cancer, meningitis
(inflammation of the thin layers of tissue that cover and protect the brain and spinal cord)
and other disorders.  
Check kidney function and liver function.  
Your urine will be tested to check your kidney function. This will be completed as part of your
clinical care.  
Scans will be performed if you have not completed scan(s) within 6 weeks of enrollment and
randomization in this study. All scans/imaging will be completed as part of your clinical
care.
You will have a CT scan or PET/CT scan (special X-rays) or X-ray of your chest, a CT scan or
PET/CT scan of your abdomen and pelvis, and a magnetic resonance imaging (MRI) scan or CT
scan of your head. Contrast dye may be used for these scans

0100000  
For the testing that is done for Clinical Care as noted above, the results of those tests will be gleaned
from your medical record and used in this research.  
Findings of unexpected tumors/changes in disease on these scans may lead to additional tests
(performed as part of your medical care) to determine if you should be treated in a manner other than
enrollment in this study.  
If the screening tests show you are eligible you will return again (within 14 days of randomization) to
begin study treatment visits.

At each study visit you will undergo tests and/or reviews is to make sure you are healthy enough to
continue to participate in the study and/or that you have not had disease progression (disease get
worse) that may require a different treatment.

You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:
Vital signs (blood pressure, heart rate, temperature, etc.)
Weight
Determining your ability to function and perform daily activities. This is sometimes called a
neurological examination.
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading
Looking at your skin for vitiligo (smooth white patches on your skin)
Determining your nerve function
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded.
Testing your vision (both visual sharpness and color vision)
Looking at your hair and eye color
Determining whether you have any symptoms that will be considered pre-existing and not
related to the research
About 1/3 tablespoon of blood will be tested for antinuclear antibody/RF (rheumatoid factor) factor,
which will help identify an autoimmune disease. This will be done for research purposes.
About 10 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.
You will receive the experimental vaccine (LPV7 and polyICLC). This will be done for research
purposes.
You will be given a Symptom Diary to keep; you will log/track any symptoms you may have using
this Symptom Diary, noting the time of the beginning of a symptom in the appropriate day/symptom
box. Study staff will review this procedure with you. Bring this completed diary with you to your
next visit, at which time the clinician will review the diary that was given to you at the last visit to see
if you had any symptoms after receiving the study drug. You will also be given a new diary at each
visit. The symptom review and symptom diary will be performed as part of the research study.  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:  
Vital signs (blood pressure, heart rate, temperature, etc.)  
Weight  
Determining your ability to function and perform daily activities. This is sometimes called a
neurological examination.  
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading  
Looking at your skin for vitiligo (smooth white patches on your skin)  
Determining your nerve function  
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded.  
Testing your vision (both visual sharpness and color vision)  
Looking at your hair and eye color  
Determining whether you have any symptoms that will be considered pre-existing and not
related to the research  
About 1/3 tablespoon of blood will be tested for antinuclear antibody/RF (rheumatoid factor) factor,
which will help identify an autoimmune disease. This will be done for research purposes.  
About 10 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.  
You will receive the experimental vaccine (LPV7 and polyICLC). This will be done for research
purposes.  
You will be given a Symptom Diary to keep; you will log/track any symptoms you may have using
this Symptom Diary, noting the time of the beginning of a symptom in the appropriate day/symptom
box. Study staff will review this procedure with you. Bring this completed diary with you to your
next visit, at which time the clinician will review the diary that was given to you at the last visit to see
if you had any symptoms after receiving the study drug. You will also be given a new diary at each
visit. The symptom review and symptom diary will be performed as part of the research study.

You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:
Vital signs (blood pressure, heart rate, temperature, etc.)
Weight
Determining your ability to function and perform daily activities
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded
Reviewing any health problems you experienced since your last visit
You will have three 4mm biopsies of the vaccine site. This tissue will be used for research purposes
to study your body's cells under a microscope.
You will receive the experimental vaccine. This will be done for research purposes.
About 7 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.
Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:  
Vital signs (blood pressure, heart rate, temperature, etc.)  
Weight  
Determining your ability to function and perform daily activities  
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading  
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded  
Reviewing any health problems you experienced since your last visit  
You will have three 4mm biopsies of the vaccine site. This tissue will be used for research purposes
to study your body's cells under a microscope.  
You will receive the experimental vaccine. This will be done for research purposes.  
About 7 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.  
Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.

You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:
Vital signs (blood pressure, heart rate, temperature, etc.)
Weight
Determining your ability to function and perform daily activities
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded
Reviewing any health problems you experienced since your last visit
You will receive the experimental vaccine. This will be done for research purposes.
Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:  
Vital signs (blood pressure, heart rate, temperature, etc.)  
Weight  
Determining your ability to function and perform daily activities  
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading  
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded  
Reviewing any health problems you experienced since your last visit  
You will receive the experimental vaccine. This will be done for research purposes.  
Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.

You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:
Vital signs (blood pressure, heart rate, temperature, etc.)
Weight
Determining your ability to function and perform daily activities
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading
Looking at your skin for vitiligo (smooth white patches on your skin)
Determining your nerve function  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:  
Vital signs (blood pressure, heart rate, temperature, etc.)  
Weight  
Determining your ability to function and perform daily activities  
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading  
Looking at your skin for vitiligo (smooth white patches on your skin)  
Determining your nerve function

Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded
Reviewing any health problems you experienced since your last visit
About 1/3 tablespoon of blood will be collected to check your blood counts, certain levels of fats,
salts and sugars, kidney and liver function, and your immune system. This blood will also be used
to check your LDH levels. This will be done for research purposes.
About 1/3 tablespoon of blood will be tested for antinuclear antibody/RF (rheumatoid factor) factor,
which will help identify an autoimmune disease. This will be done for research purposes.
About 7 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.
You will have three 4mm biopsies of the vaccine site. This tissue will be used for research purposes
to study your body's cells under a microscope.
Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.  
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded  
Reviewing any health problems you experienced since your last visit  
About 1/3 tablespoon of blood will be collected to check your blood counts, certain levels of fats,
salts and sugars, kidney and liver function, and your immune system. This blood will also be used
to check your LDH levels. This will be done for research purposes.  
About 1/3 tablespoon of blood will be tested for antinuclear antibody/RF (rheumatoid factor) factor,
which will help identify an autoimmune disease. This will be done for research purposes.  
About 7 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.  
You will have three 4mm biopsies of the vaccine site. This tissue will be used for research purposes
to study your body's cells under a microscope.  
Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.

You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:
Vital signs (blood pressure, heart rate, temperature, etc.)
Weight
Determining your ability to function and perform daily activities
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded
Reviewing any health problems you experienced since your last visit
You will receive the experimental vaccine, This will be done for research purposes.
Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:  
Vital signs (blood pressure, heart rate, temperature, etc.)  
Weight  
Determining your ability to function and perform daily activities  
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading  
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded  
Reviewing any health problems you experienced since your last visit  
You will receive the experimental vaccine, This will be done for research purposes.  
Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.

You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:
Vital signs (blood pressure, heart rate, temperature, etc.)
Weight
Determining your ability to function and perform daily activities
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded
Reviewing any health problems you experienced since your last visit
About 7 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:  
Vital signs (blood pressure, heart rate, temperature, etc.)  
Weight  
Determining your ability to function and perform daily activities  
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading  
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded  
Reviewing any health problems you experienced since your last visit  
About 7 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.

Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.

You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:
Vital signs (blood pressure, heart rate, temperature, etc.)
Weight
Determining your ability to function and perform daily activities
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded
Reviewing any health problems you experienced since your last visit
You will receive the experimental vaccine. This will be done for research purposes.
Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:  
Vital signs (blood pressure, heart rate, temperature, etc.)  
Weight  
Determining your ability to function and perform daily activities  
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading  
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded  
Reviewing any health problems you experienced since your last visit  
You will receive the experimental vaccine. This will be done for research purposes.  
Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.

You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:
Vital signs (blood pressure, heart rate, temperature, etc.)
Weight
Determining your ability to function and perform daily activities
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded
Reviewing any health problems you experienced since your last visit
About 1/3 tablespoon of blood will be collected to check your blood counts, certain levels of fats,
salts and sugars, kidney and liver function, and your immune system. This blood will also be used
to check your LDH levels. This will be done for research purposes.
About 1/3 tablespoon of blood will be tested for antinuclear antibody/RF (rheumatoid factor) factor,
which will help identify an autoimmune disease. This will be done for research purposes.
You will receive the experimental vaccine. This will be done for research purposes.
Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
research purposes and will include:  
Vital signs (blood pressure, heart rate, temperature, etc.)  
Weight  
Determining your ability to function and perform daily activities  
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading  
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded  
Reviewing any health problems you experienced since your last visit  
About 1/3 tablespoon of blood will be collected to check your blood counts, certain levels of fats,
salts and sugars, kidney and liver function, and your immune system. This blood will also be used
to check your LDH levels. This will be done for research purposes.  
About 1/3 tablespoon of blood will be tested for antinuclear antibody/RF (rheumatoid factor) factor,
which will help identify an autoimmune disease. This will be done for research purposes.  
You will receive the experimental vaccine. This will be done for research purposes.  
Your symptom diary will be reviewed and you will be given a new symptom diary to keep. Please
bring the completed diary with you to your next visit. The symptom review and symptom diary will
be performed as part of the research study.  
Day 85, Week 12

0100000  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
clinical and research purposes and will include:
Vital signs (blood pressure, heart rate, temperature, etc.)
Weight
Determining your ability to function and perform daily activities
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading
Looking at your skin for vitiligo (smooth white patches on your skin)
Determining your nerve function
Testing your vision (both visual sharpness and color vision)
Looking at your hair and eye color
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded
Reviewing any health problems you experienced since your last visit
About 1/3 tablespoon of blood will be collected to check your blood counts, certain levels of fats,
salts and sugars, kidney and liver function, and your immune system. This blood will also be used
to check your LDH levels. This will be done for clinical care purposes.
You will have a chest X-ray or CT scan. This will be done as part of your clinical care.
About 7 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.
Your symptom diary will be reviewed by the study clinician. This will be done for research
purposes.  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
clinical and research purposes and will include:  
Vital signs (blood pressure, heart rate, temperature, etc.)  
Weight  
Determining your ability to function and perform daily activities  
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading  
Looking at your skin for vitiligo (smooth white patches on your skin)  
Determining your nerve function  
Testing your vision (both visual sharpness and color vision)  
Looking at your hair and eye color  
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded  
Reviewing any health problems you experienced since your last visit  
About 1/3 tablespoon of blood will be collected to check your blood counts, certain levels of fats,
salts and sugars, kidney and liver function, and your immune system. This blood will also be used
to check your LDH levels. This will be done for clinical care purposes.  
You will have a chest X-ray or CT scan. This will be done as part of your clinical care.  
About 7 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.  
Your symptom diary will be reviewed by the study clinician. This will be done for research
purposes.

Day 183, Week 26  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
clinical and research purposes and will include:
Vital signs (blood pressure, heart rate, temperature, etc.)
Weight
Determining your ability to function and perform daily activities
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading
Looking at your skin for vitiligo (smooth white patches on your skin)
Determining your nerve function
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded
Reviewing any health problems you experienced since your last visit
About 1/3 tablespoon of blood will be tested for antinuclear antibody/RF (rheumatoid factor) factor,
which will help identify an autoimmune disease. This will be done for research purposes.
You will have a chest X-ray or CT scan. This will be done as part of your clinical care.
About 7 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
clinical and research purposes and will include:  
Vital signs (blood pressure, heart rate, temperature, etc.)  
Weight  
Determining your ability to function and perform daily activities  
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading  
Looking at your skin for vitiligo (smooth white patches on your skin)  
Determining your nerve function  
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded  
Reviewing any health problems you experienced since your last visit  
About 1/3 tablespoon of blood will be tested for antinuclear antibody/RF (rheumatoid factor) factor,
which will help identify an autoimmune disease. This will be done for research purposes.  
You will have a chest X-ray or CT scan. This will be done as part of your clinical care.  
About 7 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.

You will have a physical exam with a licensed clinician. The physical exam will be performed for
clinical and research purposes and will include:
Vital signs (blood pressure, heart rate, temperature, etc.)
Weight
Determining your ability to function and perform daily activities
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded
Reviewing any health problems you experienced since your last visit
About 7 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.  
You will have a physical exam with a licensed clinician. The physical exam will be performed for
clinical and research purposes and will include:  
Vital signs (blood pressure, heart rate, temperature, etc.)  
Weight  
Determining your ability to function and perform daily activities  
Looking at your skin and lymph nodes for evidence of disease recurrence or spreading  
Reviewing the medications that you are taking; including any over-the-counter, alternative
medications, herbal medications, or supplements will be recorded  
Reviewing any health problems you experienced since your last visit  
About 7 tablespoons of blood will be collected from a vein to test your immune response to the
experimental drugs and adjuvants that you will receive. This will be done for research purposes.

During the course of the study, you may require one or more additional tests, treatments and/or
procedures. These may be performed as a part of your clinical care.  
In addition, if you were to experience a skin reaction, it is possible that the digital photographs (not
including your full face) might be needed to fully document the reaction.

Study Calendar of Procedures and Tests  
Bold "x" indicates activity performed for research purposes at that visit.
1Follow-up contacts- at least annually.

We will take (or "draw") up to about 11 tablespoons of blood on days when blood is to be drawn. The
total amount of blood we will take will be about 64 tablespoons over 2 years.

The blood we take will be tested to measure  
measure the amount of red and white blood cells in your blood;
check how well your kidneys/liver work;
measure the amount of certain fats, salts, and sugar in your blood;
check your immune system;
test your immune response to the experimental vaccine and reagents you received  
measure the amount of red and white blood cells in your blood;  
check how well your kidneys/liver work;  
measure the amount of certain fats, salts, and sugar in your blood;  
check your immune system;  
test your immune response to the experimental vaccine and reagents you received

During the study, your study leader will let you know of any test results that may be important to your
health. In addition, as the research moves forward, your study leader will keep you informed of any
new findings that may be important for your health or may help you decide if you want to continue in the
study. The final results of the research will not be known until all the information from everyone is
combined and reviewed. At that time, you can ask for more information about the study results.

You are being asked to provide samples of your blood and tumor tissue to be used for futureresearch.
Along with specimens, researchers may need to collect some health information about you. Combining
information from the specimen with information from your health records may be useful for this
research. For this research, the following types of information could be included:  
diagnosis
treatment
age
gender
sample type  
diagnosis  
treatment  
age  
gender  
sample type  
If you agree, we plan to do future genetic research on the DNA in your specimen sample. DNA is
the material that makes up your genes. All living things are made of cells. Genes are the part of cells
that contain the instructions which tell our bodies how to grow and work, and determine physical
characteristics such as hair and eye color. Genes are passed from parent to child.  
In addition, if you agree, specimens collected for research will be added to a research specimen
bank. The purpose of a specimen bank is to process, and store samples until researchers need them
for future research. The long-term goals of the samples collected in this bank will be mainly used for
research on melanoma. It is not possible, however, to list every research project that will include the
samples because we cannot predict all of the research questions that will be important over the coming
years. As we learn more, new research questions and new types of research may be done.  
Your specimen sample may be used to create a living specimen sample (called a "cell line") that can be
grown in the laboratory. This allows researchers to have an unlimited supply of your cells in the future
without asking for more samples from you.

Your doctor will obtain blood and tumor tissue for testing. These samples will be collected as part of the
research study at the time points described above. If your tumor grows back and tumor tissue is
removed, a portion of the tissue may be saved for research. All of these specimens may be used for
genetic research and may also be banked and used in future research studies.

HLA typing may be performed as part of your clinical care. However, in order to participate in this study,
the results of your HLA typing is required. Therefore, in order to participate in this study, you must
undergo HLA typing as part of your clinical care if you do not already have HLA testing results. If HLA
typing is performed as part of your clinical care, the result will be placed in your medical record.  
HLA is a special protein commonly found in the body, especially in white blood cells. There are many
different types of HLA. Because of this HLA testing is very good at figuring out things like if a person is
a good match as an organ donor, how likely a person is to develop a disease or condition, or paternity
testing (being able to figure out the biological parents of a person.)

IRB 15931: PHASE I/II TRIAL OF A LONG PEPTIDE VACCINE (LPV7) PLUS TLR AGONISTS FOR RESECTED
STAGE IIB - IV MELANOMA  
Part 2  
0100000  
Norplant
IUD (intrauterine device)
Birth Control Pills
Depo-Provera
Birth Control Patch
Sterilization  
Norplant  
IUD (intrauterine device)  
Birth Control Pills  
Depo-Provera  
Birth Control Patch  
Sterilization  
The birth control methods listed below are less effective. They may be used if combined with other
birth control methods:  
Condoms
Jellies or foam
Diaphragm
Withdrawal
Rhythm
Sponge
Cervical cap  
Condoms  
Jellies or foam  
Diaphragm  
Withdrawal  
Rhythm  
Sponge  
Cervical cap  
Ask your doctor for more details about the proper birth control method for you. If you become pregnant
during this study, you must tell your doctor right away. Your doctor will discuss your treatment and the
effect on the pregnancy.

The following procedures/tests, which are being done for research purposes, will be provided at no cost to
you or your health insurance:  
Vaccines and administration of the vaccines
Physical Exams (Days 1, 8, 15, 22, 36, 57, 78)
Research blood draws for Immunologic Analyses
Blood draws to check your immune system (ANA and Rf)
Blood draws to check your blood counts, certain levels of fats, salts and sugars, kidney and liver
function (Days 22 and 78)
Vaccine Site Biopsies
Eye exams
Examinations of skin for vitiligo
Examinations of hair and eye color
Toxicity diaries and review of diaries  
Vaccines and administration of the vaccines  
Physical Exams (Days 1, 8, 15, 22, 36, 57, 78)  
Research blood draws for Immunologic Analyses  
Blood draws to check your immune system (ANA and Rf)  
Blood draws to check your blood counts, certain levels of fats, salts and sugars, kidney and liver
function (Days 22 and 78)  
Vaccine Site Biopsies  
Eye exams  
Examinations of skin for vitiligo  
Examinations of hair and eye color  
Toxicity diaries and review of diaries  
You and/or your insurance company must pay for any tests or care given beyond what is required in
this study. In addition, you and/or your health insurance may also have to pay for other drugs or
treatments that are given to help you control any side effects. You will have to pay for any costs not
covered by your health plan. You may be responsible for any co-payments or deductibles. You may wish
to ask your insurance company for an estimate of what these costs might be or if pre-approval is required.  
You will be responsible for the cost of travel to come to any study visit and for any parking costs.

| Study Calendars of Procedures and Tests                                                                                    | Screening    | Day    | 1    | 8    | 15       | 22    | 36            | 43    | 57     | 78    | 85    | 183       | 365    | 730    | Annual Contact    |
|----------------------------------------------------------------------------------------------------------------------------|--------------|--------|------|------|----------|-------|---------------|-------|--------|-------|-------|-----------|--------|--------|-------------------|
|                                                                                                                            |              | Week   | 0    | 1    | 2        | 3     | 5             | 6     | 8      | 11    | 12    | 26        | 52     | 104    |                   |
| Informed Consent                                                                                                           | [X]          | [ ]    | [ ]  | [ ]  | [ ]      |       |               |       |        |       |       | [ ]       | [ ]    | [ ]    |                   |
| Review of Pathology                                                                                                        | [X]          | [ ]    | [ ]  | [ ]  | [ ]      | [ ]   | [ ]           | [ ]   |        | [ ]   |       | [ ]       | [ ]    | [X]    |                   |
| Medical History                                                                                                            | [X]          | [ ]    | [ ]  | [ ]  |          | [ ]   | [ ]           | [ ]   | [ ]    | [ ]   | [ ]   | [ ]       | [ ]    | [ ]    |                   |
| Urine Test                                                                                                                 | [X]          | [ ]    | [ ]  | [ ]  | [ ]      | [ ]   | [ ]           | [ ]   | [ ]    | [ ]   | [ ]   | [ ]       | [ ]    | [ ]    |                   |
| Abdomen and Pelvic CT scan, head MRI or CT                                                                                 | [X]          | [ ]    | [ ]  | [ ]  | [ ]      | [ ]   | [ ]           | [ ]   | [ ]    | [ ]   | [ ]   | [ ]       | [ ]    | [ ]    | [ ]               |
| Chest x-ray CT                                                                                                             | [X]          | [ ]    | [ ]  | [ ]  | [ ]      | [ ]   | [ ]           | [ ]   | [ ]    | [ ]   | [X]   | [X]       | [ ]    | [ ]    | [ ]               |
| Blood draw to test to count red blood cell, white blood cells, sugars, salts and see how the liver and kidneys are working | [X]          | [ ]    | [ ]  | [ ]  | [ ]      | [X] X | [ ]           | [ ]   | [ ]    | [ ]   | [ ]   | [ ]       | [ ]    | [ ]    | [ ]               |
| Blood draw for Research                                                                                                    | [ ]          | [ ]    | [X]  | [X]  | [ ]      | [X]   | [ ]           | [X]   | [ ]    | [X]   | [X]   | XXXXX [X] | [X]    | [X]    | [ ]               |
| Physical Exam                                                                                                              | [X]          | [ ]    | [X]  | [X]  | [X]      | [X]   | [X]           | [X]   | [X]    | [X]   | [X]   | [X]       | [X]    | [X]    | [ ]               |
| Eye Exam                                                                                                                   | [ ]          | [ ]    | [X]  | [ ]  | [ ]      | [ ]   | [ ]           | [ ]   | [ ]    | [ ]   | [X]   | [ ]       | [ ]    | [ ]    | [ ]               |
| Examination of hair and eye color                                                                                          | [ ]          | [ ]    | [X]  | [ ]  | [ ]      | [ ]   | [ ]           | [ ]   | [ ]    | [ ]   | [X]   | [ ]       | [ ]    | [ ]    | [ ]               |
| Examination of skin for vitiligo                                                                                           | [ ]          | [ ]    | [X]  | [ ]  | [ ]      | [X]   | [ ]           | [ ]   | [ ]    | [ ]   | [X]   | [X]       | [ ]    | [ ]    | [ ]               |
| Toxicity diary (review/distribute)                                                                                         | [ ]          | [ ]    | [X]  |      |          | [ ]   | XXXXXXXXX [X] | [X]   | [X]    | [X]   |       | [ ]       | [ ]    | [ ]    | [ ]               |
| Vaccine site biopsy (all participants)                                                                                     | [ ]          | [ ]    | [ ]  | [X]  | [ ]      | [X]   | [ ]           | [ ]   | [ ]    | [ ]   | [ ]   | [ ]       | [ ]    | [ ]    | [ ]               |
| Administration of research drugs/agents                                                                                    | [ ]          | [ ]    |      | [X]  | [X] XXXI | [ ]   | [X]           | [ ]   | [X] XX | [X]   | [ ]   | [ ]       | [ ]    | [ ]    | [ ]               |
| Follow-up Contact1                                                                                                         | [ ]          | [ ]    | [ ]  |      | [ ]      | [ ]   | [ ]           |       | [ ]    | [ ]   |       | [ ]       | [ ]    | [ ]    | [X] X             |

Bold "x" indicates activity performed for research purposes at that visit.

1Follow-up contacts- at least annually.
Clinical trial: NCT02126579
Section: Purpose of Research
Subsections: Why is this research being done?|Why is this research being done?|What Are the Benefits To Donating Your Sample(s) For Future Genetic Research and Specimen Banking?|What Are the Benefits To Donating Your Sample(s) For Future Genetic Research and Specimen Banking?|Who will see your private information?

The purpose of this study is to learn what effects (good and bad) an experimental vaccine (LPV7) and
other substances called polyICLC, resiquimod, and Montanide ISA-51 have on melanoma. The study
has two parts, Part 1 and Part 2.  
In Part 1 of this study, the experimental vaccine (LPV7) was tested in seven different combinations of
the other study drugs, changing the location where the vaccine is given each time. The combination of
the experimental vaccine (LPV7) and the substance polyICLC were determined to have the best results
of the different combinations. Part 1 of the study is now complete and the experimental vaccine with the
best results were chosen for continued testing in Part 2.

The purpose of Part 2 is to test the safety of the experimental vaccine with the best result in Part 1
(LPV7 and polyICLC) when it is given in the same injection location, and to study changes in your
immune system.  
Fifty subjects received study treatment in Part 1 of this study at all locations. Thirty-five subjects signed
consent at UVA in part 1. Up to 40 more people will sign consent for this part (Part 2) of the study at
UVA. A total of 75 subjects will sign consent at UVA.

The genetic research and/or specimen banking that is done with your sample is not meant to help you.
But, doctors hope that in the future it will help people who have other diseases or conditions.

It is very unlikely that any future research (specimen banking) performed using your specimen(s) would
benefit you directly, but it may provide important medical knowledge that could help other patients with
your medical condition or other medical problems in the future.

The researchers to make sure they can conduct the study the right way, observe the effects of the
study and understand its results
Clinical trial: NCT02126579
Section: Voluntary Participation
Subsections: |What is the purpose of this form?|Will You Be Paid For Donating Your Sample(s) for Future Genetic Research and Specimen Banking?|Will you be paid for being in this study?|How will your personal information be shared?|What does your signature mean?

In this form "you" means a person 18 years of age or older who is being asked to volunteer to
participate in this study.  
Participant's Name  
Medical Record #  
Principal Investigator:
Craig L. Slingluff, M.D.
University of Virginia Health System
Human Immune Therapy Center
Box 801457
Charlottesville, VA 22908
Telephone: 434-924-9311

This form will provide you with information about this research study. You do not have to be in the study
if you do not want to. You should have all your questions answered before you agree to be in this study.  
Please read this form carefully. If you want to be in the study, you will need to sign this form. You will
be given a signed copy of this form.

You will not be paid to donate your sample(s) for future genetic research and specimen banking.  
Will Donating Your Sample(s) Cost You Any Money?  
There is no cost to you to have your samples collected or used for future genetic research and
specimen banking.  
Genetic Testing and Specimen Banking Options:  
You must agree to have HLA testing performed as part of your clinical care (if it has not
been done previously done.) in order to be in the study.
You must agree to allow the study team to use the results of clinically performed HLA
typing for research
You have the choice to find out the results of the HLA testing (see below).
You do not have to participate and agree to future genetic research and specimen
banking in order to be in the main part of this study.  
You must agree to have HLA testing performed as part of your clinical care (if it has not
been done previously done.) in order to be in the study.  
You must agree to allow the study team to use the results of clinically performed HLA
typing for research  
You have the choice to find out the results of the HLA testing (see below).  
You do not have to participate and agree to future genetic research and specimen
banking in order to be in the main part of this study.  
No matter what you decide to do, your decision will not affect your medical care. You can tell us
your choice by placing your initials in one of the options below:  
HLA TYPING (study team disclosure of results from clinical care testing):  
Please indicate your choice by placing your initials below:  
YES
I want the study team to tell me my HLA results.
NO
I do NOT want the study team to tell me my HLA results  
YES
I want the study team to tell me my HLA results.  
NO
I do NOT want the study team to tell me my HLA results  
SPECIMEN BANKING AND FUTURE GENETIC RESEARCH:  
Please indicate your choice by placing your initials below:  
YES
Your sample(s) may be saved for future research and stored in a
specimen bank.
NO
Your sample(s) may not be saved for future research and stored
in a specimen bank.  
YES
Your sample(s) may be saved for future research and stored in a
specimen bank.  
NO
Your sample(s) may not be saved for future research and stored
in a specimen bank.

You will not get any money for being in this study.  
By agreeing to be in this study, you are donating your blood and tissue samples for research, and
giving up any property rights you may have in them. The results of this research using your donated
materials may have commercial value. However, you will not receive any payments.

The UVa researchers are asking for your permission to gather, use and share information about you for
this study. If you decide not to give your permission, you cannot be in this study, but you can continue
to receive regular medical care at UVA.

Before you sign this form, please ask questions about any part of this study that is not clear to you.
Your signature below means that you have received this information and all your questions have been
answered. If you sign the form it means that you agree to join the study. You will receive a copy of this
signed document.
Clinical trial: NCT02126579
Section: Withdrawal from Study
Subsections: What If You Change Your Mind About Donating Your Sample(s) for Future Genetic Research and Specimen Banking?|What If You Change Your Mind About Donating Your Sample(s) for Future Genetic Research and Specimen Banking?|What happens if you leave the study early?|What if you sign the form but then decide you don't want your private information shared?|Notification of My Health Care Provider

If you decide now that your sample(s) can be kept for future genetic research and specimen banking,
and later change your mind, you can simply withdraw the sample(s) at that time. To withdraw you will

need to write to the Principal Investigator listed on the first page of this form. We will then destroy any
of your tissue that has not already been used. However, if your sample has been used in genetic
research, the information that we have learned will remain in the study, even if you withdraw. Unless
you withdraw from the study, permission for researchers to use your tissue and to use and share your
private health information for this study will never end.

You can change your mind about being in the study any time. You can agree to be in the study now
and change your mind later. If you decide to stop, please tell us right away. You do not have to be in
this study to get services you can normally get at the University of Virginia.  
Even if you do not change your mind, the study leader can take you out of the study. Some of the
reasons for doing so may include  
a) Your study physician is concerned about your health
b) Your disease gets worse
c) The side effects of the treatment are too dangerous for you
d) New information shows the treatment will not work or is not safe for you
e) You do not follow your doctor's instructions
f) The study sponsor closes the study for safety, administrative or other reasons  
a) Your study physician is concerned about your health  
b) Your disease gets worse  
c) The side effects of the treatment are too dangerous for you  
d) New information shows the treatment will not work or is not safe for you  
e) You do not follow your doctor's instructions  
f) The study sponsor closes the study for safety, administrative or other reasons  
If you decide to stop being in the study, we will ask you to notify Dr. Slingluff as soon as possible.  
Any data collected about you up until the time you leave the study must be kept in order to determine
the results of the study.

You can change your mind at any time. Your permission does not end unless you cancel it. To cancel
it, please send a letter to the researchers listed on this form or complete the "Leaving the Study Early"
part of this form and return it to the researchers. Then you will no longer be in the study. The
researchers will still use information about you that was collected before you ended your participation.  
Your information, collected for this study, will be protected by a Certificate of Confidentiality from the
federal government. If UVA receives a subpoena or court order demanding information from the study
records that would identify you, we will use the Certificate to resist the demand. However, UVa will not
use it in the following cases.  
You have agreed in writing to allow UVa to share the information with your employer, your
insurance company for billing purposes, or someone else
Reports to authorities where there is a danger that you may harm yourself or others, or if there
is evidence of probable child or elder abuse or neglect.
Reports to authorities if you have an infectious disease that health care providers are required
to report by law.  
You have agreed in writing to allow UVa to share the information with your employer, your
insurance company for billing purposes, or someone else  
Reports to authorities where there is a danger that you may harm yourself or others, or if there
is evidence of probable child or elder abuse or neglect.  
Reports to authorities if you have an infectious disease that health care providers are required
to report by law.

Signatures should be obtained in this section if the subject decides to leave the study early.  
If you leave the study early the study leader will keep the data collected about you up until the time you
leave the study to help determine the results of the study.  
Check one option below:  
I am withdrawing my consent from the intervention or treatment part of this study but agree to
continue to have follow up information about me collected by the study team.  
The follow up information will be collected by any of the following:  
Obtaining information from my medical records
Phone call
In person follow up visit (please see descriptions in follow up section)  
Obtaining information from my medical records  
Phone call  
In person follow up visit (please see descriptions in follow up section)  
I am withdrawing my consent for this study. No additional information may be collected about me
including follow up information from my medical records.