Clinical trial: NCT03481816
Section: Alternatives
Subsections: Alternative Approaches Or Treatments What Other Choices Do I Have If I Do Not Take Part In This Study?

Instead of being in this study, you have these options:
- Getting treatment or care for your cancer without being in a study  
- Taking part in another study
- Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
Please talk to your doctor about these and other options.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent
Clinical trial: NCT03481816
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:  
- The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people.  
- National Cancer Institute Institutional Review Board
- Qualified representatives from Etubics, the pharmaceutical company who produces ETBX071, ETBX-061, and ETBX-051.
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.

To help us protect your privacy, we have obtained a Certificate of Confidentiality. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below. You should also know that there are several circumstances in which the Certificate does not provide coverage. These include when information:
- will be used for auditing or program evaluation internally by the NIH; or  
- must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA).  
- is necessary for your medical treatment and you have consented to this disclosure;
- is for other research.
In addition, identifiable, sensitive information protected by this Certificate cannot be admissible as evidence or used for any purpose in any action, suit, or proceeding without your consent.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers will not use the Certificate to withhold that information. The Certificate of Confidentiality will not protect against the required reporting by hospital staff of information on suspected child abuse, reportable communicable diseases, and/or possible threat of harm to self or others.
Clinical trial: NCT03481816
Section: Duration of Study Involvement
Subsections: During The Study|When You Are Finished Taking The Treatment

Once it has been determined that you are eligible and agree to participate in the study, you may need to have some of the tests that were done at screening repeated depending on how much time has passed. Your study team will let you know if any of the above tests need to be repeated.  
You will receive ETBX-071, ETBX-061 and ETBX-051 vaccines by subcutaneous injections (shots under the skin) every 3 weeks for 3 doses in dose expansion group. If you are enrolled in second group (dose escalation group) you will receive ETBX-071, ETBX-061 and ETBX-051 vaccines by subcutaneous injections (shots under the skin) every 3 weeks for 3 doses and then every 8 weeks for up to a year. We will give you a diary card after your first vaccine so you can record any symptoms you might have at the site of injection. Please bring the card with you at the next visit. You will have blood drawn for safety every time you get your vaccinations. We will also take scans and other measurements to test the effect, if any, the vaccines have on your tumor.

You will return to the clinic for an evaluation within 28 days after your last treatment, whenever that occurs. You will have the following tests done: physical exam, vital signs, routine blood tests and urine tests. If you have ongoing significant side effects, you will continue to be followed until the side effects end or they are not changing. If you are unable to come to this visit, we will call you to find out if you are having side effects and will try to reschedule the blood tests for another time if possible.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
  
After this visit, we will continue to call you every 3 months for the first year, every 6 months for the next two years, and every 12 months for another two years to find out how you are doing and if you have started any new anti-cancer therapy. At the end of this study, we would still like to follow you for any late side effects and to see how you do on other treatments. We would request that at that time you enroll onto our Long-Term Follow-up Study 04-C-0274 which the study team can go over with you.
Clinical trial: NCT03481816
Section: Participant's Rights
Subsections: Research Subject'S Rights What Are The Costs Of Taking Part In This Study?

If you choose to take part in the study, the following will apply, in keeping with the NIH policy:  
- You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not available at the NIH.  
- There are limited funds available to cover the cost of some tests and procedures performed outside the Clinical Center, NIH. You may have to pay for these costs if they are not covered by your insurance company.  
- Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, NIH.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
- Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.
Clinical trial: NCT03481816
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation What Side Effects Or Risks Can I Expect From Being In This Study? Risks From Study Vaccines|Risks From Blood Collection|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

The combination of the ETBX-071, ETBX-061, and ETBX-051 vaccines has not been previously given to humans before, so risks and discomforts may occur that we cannot predict. While in the study, you may have side effects. They may be mild or very serious. Please tell your nurse or doctor about any side effects you experience. Your study doctor may give you medications to try to help lessen some of the side effects. All subjects in the study will be monitored for side effects. ETBX-071, ETBX-061, and ETBX-051 vaccines have not been tested in humans. The following side effects have occurred in people receiving a similar vaccine called ETBX-011.

The risks from drawing blood may include discomfort from insertion of the needle, bruising, pain, redness or swelling at site of blood drawing, fainting and rarely, infection at the site of blood drawing.

The aim of this study is to find the maximum safe dose of a combination of three immunotherapeutic vaccines (ETBX-071, ETBX-061, and ETBX-051). We do not know if you will receive personal, medical benefit from taking part in this study. These potential benefits could include shrinking of your tumor or lessening of your symptoms, such as pain, that are caused by the cancer. Because there is not much information about the drug's effect on your cancer, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.
Clinical trial: NCT03481816
Section: Procedures
Subsections: Description Of Research Study What Will Happen If You **Take Part In This Research Study?** Before You Begin The Study|Research Blood Samples:

You will need to have the following exams, tests and procedures to find out if you can be in the study. These exams, tests and procedures are part of regular cancer care and may be done even if you do not join the study. However, there are some extra exams, tests and procedures that you will need to have if you take part in this study. If you have had some of them recently, they may not need to be repeated. These tests include:
- History and physical evaluation including vital signs  
- Routine blood tests - Urine tests
- CT or MRI scan
- Bone scan  
| PATIENT IDENTIFICATION   | CONTINUATION SHEET for either: NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent   |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|  
- Hepatitis B and C screening test
- HIV testing
- PSA and testosterone levels - Electrocardiogram (ECG) to test the function of your heart

Research tests will be done on blood taken at various times during your participation in this study: baseline (before you have received any vaccines), Week 6, Week 14, Week 30 and at the end of study treatment. The NIH has set a limit on the maximum amount of blood that can be taken for research. This limit is based on your age. For adults, no more than 37 tablespoons can be taken over an 8-week period.
Clinical trial: NCT03481816
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

This research study is being done to test the safety of combination of three therapeutic vaccines (ETBX-071, ETBX-061, and ETBX-051) and to study their effects on the immune system.  
PATIENT IDENTIFICATION CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH **STUDY**
- Adult Patient or - Parent, for Minor Patient NIH-2514-1 (07-09) P.A.: 09-25-0099 File in Section 4: Protocol Consent (1)  
  
The goal of cancer vaccines is to teach the immune system to target and then kill cancer cells. The targets of these vaccines are proteins called PSA, MUC1, and brachyury which are found on many types of cancer, including prostate cancer. Similar vaccine therapies which have targeted one or two of these proteins have been very well tolerated, and had few side effects. Data in animal studies suggests that targeting all three of these proteins may lead to better results than targeting just one or two of these proteins. Therefore, this trial aims to target all three of these proteins in unison. ETBX-071, ETBX-061, and ETBX-051 vaccines have not been tested in humans; either individually or in combination. This study will be the first time the vaccine combination has been given to humans. This vaccine combination is an investigational agent that has not been approved by the US Food and Drug Administration (FDA).
Clinical trial: NCT03481816
Section: Voluntary Participation
Subsections: Why Are You Being Asked To Take Part In This Study?

You are being invited to participate in a research study because you have been diagnosed with metastatic castration resistant prostate cancer (mCRPC) that has not responded to standard cancer therapies.
Clinical trial: NCT03481816
Section: Withdrawal from Study
Subsections: Stopping Therapy

Your doctor may decide to stop your therapy for the following reasons:  
- if he/she believes that it is in your best interest - if your disease comes back during treatment
- if you have side effects from the treatment that your doctor thinks are too severe
- if the investigator decides to end the study
- if new information shows that another treatment would be better for you
In this case, you will be informed of the reason therapy is being stopped. You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first. If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, according to FDA guidelines, information collected on you up to that point may still be provided to Etubics or designated representatives. If you withdraw your consent and leave the trial, any samples of yours that have been obtained for the study and stored at the NCI can be destroyed upon request. However, any samples and data generated from the samples that have already been distributed to other researchers or placed in the research databases cannot be recalled and destroyed.