Clinical trial: NCT03057613
Section: Duration of Study Involvement
Subsections: How Long Will I Be In The Study?

You will be treated on the study for four months.  You will still be in the study for a full year where you will have follow up visits.  Afterwards, you will have regular cancer follow up appointments by your doctors as per the usual care and no longer be in the research study.
Clinical trial: NCT03057613
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Re, Some May Be Serious|Potential Risk Or Discomfort From Research Procedures Blood Draws|Ct Scans|X-Ray|Magnetic Resonance Imaging (Mri)|Are There Reproductive Risks To Being In This Study?

In 100 people receiving pembrolizumab, less than 1 person may have the following:
Inflammation of the pancreas (a gland in your abdomen that controls sugar levels) so
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you may have severe pain in the top part of your belly that may move to your back, feel sick to your stomach, and/or have vomiting that gets worse when you eat Inflammation of the eye so you may have eye redness, blurred vision, sensitive
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sensitivity to light, have eye pain, and/or see floaters or have headaches Inflammation of the liver that may make you feel sick to your stomach and vomit, feel
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like not eating, feeling tired, have a mild fever, have a pain in the right side of your belly muscle or joint aches, sick to your stomach and vomiting, pain in your belly, yellow eyes and skin, and dark urine Inflammation of the pituitary gland (a gland in the head), which may cause you to feel
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sick to your stomach or have headaches, sick to your stomach, changes in your behavior, double vision, few to no menstrual cycles, weakness, vomiting and dizziness or fainting Adrenal glands (glands on top of the kidneys) that may not make enough hormone,
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which could cause causing tiredness, weight loss, muscle weakness, feeling faint, joint, muscle and belly aches, nausea, vomiting, loose or watery stools, fever, salt craving, and sometimes darkening of the skin like a suntan Type 1 Diabetes, a condition that can cause too much sugar in your blood, feeling
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thirstier than usual, frequent urination and weight loss. You are likely to need regular insulin shots.  
Inflammation of the kidney so you may pass less urine or have cloudy or bloody urine,
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swelling and low back pain Inflammation of the middle layer of your heart wall (myocarditis) that may cause your
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heart to have difficulty pumping blood throughout your body, which can cause chest pain, shortness of breath and swelling of the legs. You may experience a fast or irregular heartbeat that may cause dizziness or fainting.  
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Inflammation of the thyroid gland, an organ that makes and stores thyroid hormones.  
This condition may lead to change in your heart rate, blood pressure, body temperature, and the rate at which food is converted into energy.  
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A condition that may make you feel weak and tired and might have drooping of the eyelids, blurred or double vision, difficulty swallowing, slurred speech, weakness in your arms and legs, or difficulty breathing The formation of small clusters of immune cells (called granulomas) in parts of your
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body such as your lymph nodes, eyes, skin, or lungs
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Inflammation of the brain with confusion and fever. This may also include:
disorientation, memory problems, seizures (fits), changes in personality and behavior, difficulty speaking, weakness or loss of movement in some parts of your body, and loss of consciousness Additionally, since pembrolizumab was approved in September 2014, the following side effects, have been reported by people receiving pembrolizumab.  
CASE 6316 12/04/2019 Consent 12/17/2019 These side effects were voluntarily reported from a group of people of unknown size.  It is not possible to estimate the frequency of this side effect:
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Inflammation of the joints which may include joint pain, stiffness and/or swelling
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Severe responses of the immune system that cause the body to attack its own blood cells, spleen, liver, lymph nodes, skin and brain. This may include fever, rash, inflammation of the liver, yellowing of the skin, an enlarged liver and spleen, low blood counts, and enlarged lymph nodes. The nervous system may also be affected and cause confusion, seizures, and even coma.
In addition to the above, if you have had an allogeneic stem cell transplant (a procedure in which a person receives blood-forming stem cells from a donor), you may experience graft  versus host disease (GvHD), which may include diarrhea, skin rashes, and liver damage, after receiving pembrolizumab.  Sometimes this condition can lead to death.

The insertion of the needle to draw blood is painful; however, the discomfort is usually brief.  
For most people, needle punctures to get blood samples do not cause any serious problems; however, they may cause bleeding, bruising, discomfort, infections, dizziness, or fainting.

If you take part in this research study, you will have one or more medical imaging studies which use radiation.  The CT scan that you will receive in this study will expose you to low amounts of radiation. Every day, people are naturally exposed to low levels of radiation that come from the sun and the environment. This type of radiation is called "background radiation." No one knows for sure whether exposure to low amounts of radiation is harmful for your body. However, scientists believe that being exposed to too much radiation can cause harmful side effects, including causing a new cancer.   The amount of radiation that scientists think can cause harmful side effects equals more than 15 times the amount of extra radiation you would receive from being in this study. Also, scientists believe the number of people who would be at risk for developing a second cancer from being exposed to large amounts of radiation to be about 1 out of every 1,000.

We are all exposed to radiation on a daily basis both from natural (sun and earth) and man-made sources that we call background radiation. The amount of radiation from an x-ray is lower than what you are exposed to through natural sources of radiation in the environment.  
The x-ray technologists and radiologists use the smallest possible dose of radiation and provide a protective lead apron when multiple x-rays are necessary. CASE 6316 12/04/2019 Consent 12/17/2019

If you take part in this research, you may have an MRI (magnetic resonance imaging and/or magnetic resonance spectroscopy). MRI uses a magnet and radio waves to make images (pictures) of the inside of the head and/or body. There have been no ill effects reported from exposure to the magnetism or radio waves used for these studies; however, it is possible that harmful effects could be recognized in the future. A known risk is that the magnet could attract certain kinds of metal that may cause injury to you. We will ask you about metal within your body (this includes certain dyes used in tattoos and body piercings). If there is any question about potentially hazardous metal within your body, you will not be able to participate in this research study. We will also keep the MRI room locked so that no one carrying metal objects enters the room while you are having this scan performed. In addition, the MRI scanner makes a loud buzzing noise that could affect hearing ability. You will be provided with earplugs and assistance in their use in order to protect your hearing. You will be able to communicate with the scanner technologist using an intercom and/or signaling device. The technologist will try to help you feel as comfortable as possible in the scanner. You can ask to stop the scan and be removed from the scanner at any time by using the intercom or signaling device.  
There is a very slight risk of an allergic reaction if contrast material is injected. Such reactions usually are mild and easily controlled by medication. If you experience allergic symptoms, a radiologist or other physician will be available for immediate assistance.  
Gadolinium-based contrast agents (dyes) may increase the risk of a rare but serious disease called nephrogenic systemic fibrosis in people with poor kidney function. Nephrogenic systemic fibrosis triggers thickening of the skin, organs and other tissues.  There is no effective treatment for this debilitating disease.

You should not get pregnant or father a child or donate sperm while on this study or during the first 6 months after completion of therapy because the treatment can affect an unborn baby. It is important you understand that you and/or your partner need to use birth control while on this study.  You must be willing to use 2 methods of birth control or are considered highly unlikely to become pregnant.  Unlikely to become pregnant is defined as surgically sterilized or postmenopausal.  The 2 methods of birth control can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy. For more information about risks and side effects, ask your study doctor.
Clinical trial: NCT03057613
Section: Procedures
Subsections: What Extra Tests And Procedures Will I Have If I Take Part In This Study?

If you agree to participate in this study the only extra tests you will have are some extra blood tests, generally obtained at the same time standard blood work is drawn. This is to make sure it is safe to give you the Pembrolizumab and to monitor for side effects.   There will also be blood drawn for research purposes to better understand how Pemrbolizumab impacts your immune profile.
Clinical trial: NCT03057613
Section: Purpose of Research
Subsections: Questions About The Research

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Clinical trial: NCT03057613
Section: Voluntary Participation
Subsections: Voluntary Participation

Your participation in this research study is voluntary.  Choosing not to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.  If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risks or benefits associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.
Clinical trial: NCT03057613
Section: Withdrawal from Study
Subsections: Termination Of Participation

Your participation in this study may be discontinued by the investigator without your consent for any of the following reasons:
Termination of the study  
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Non-compliance with testing and procedures As clinically indicated (determined by the treating physician)
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