## Protocol Section
### Identification Module
**NCT ID:** NCT02126579

**Acronym:** MEL60

**Brief Title:** Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists

**Official Title:** Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)

#### Organization Study ID Info
**ID:** 15931
#### Organization
**Class:** OTHER
**Full Name:** University of Virginia
#### Secondary ID Infos
**Domain:** UVA Human Immune Therapy Center
**ID:** MEL60
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2021-05-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-11-20

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-11-03

**Type:** ACTUAL

**Results First Submit Date:** 2022-04-28

**Results First Submit QC Date:** 2023-10-12

#### Start Date
**Date:** 2014-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2014-04-30
**Type:** ESTIMATED
**Study First Submit Date:** 2014-04-24
**Study First Submit QC Date:** 2014-04-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Virginia

#### Lead Sponsor

**Class:** OTHER

**Name:** Craig L Slingluff, Jr

#### Responsible Party

**Investigator Affiliation:** University of Virginia

**Investigator Full Name:** Craig L Slingluff, Jr

**Investigator Title:** Professor, Department of Surgery

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to learn what effects (good and bad) an experimental vaccine (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine and these drugs cause any changes in your immune system.

### Conditions Module

**Conditions:**

- Melanoma

- Metastatic Melanoma

- Mucosal Melanoma

**Keywords:**

- melanoma

- neoplasms

- Poly ICLC

- Freund's Adjuvant

- Metastatic melanoma

- resiquimod

- adjuvants

- peptide vaccine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

**Intervention Names:**

- Biological: Peptide Vaccine (LPV7) + Tetanus peptide

- Other: IFA

**Label:** Arm A (Part 1)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

**Intervention Names:**

- Biological: Peptide Vaccine (LPV7) + Tetanus peptide

- Other: PolyICLC

**Label:** Arm B (Part 1)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after the vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

**Intervention Names:**

- Biological: Peptide Vaccine (LPV7) + Tetanus peptide

- Other: Resiquimod

**Label:** Arm C (Part 1)

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

**Intervention Names:**

- Biological: Peptide Vaccine (LPV7) + Tetanus peptide

- Other: PolyICLC

- Other: Resiquimod

**Label:** Arm D (Part 1)

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

**Intervention Names:**

- Biological: Peptide Vaccine (LPV7) + Tetanus peptide

- Other: PolyICLC

- Other: IFA

**Label:** Arm E (Part 1)

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

**Intervention Names:**

- Biological: Peptide Vaccine (LPV7) + Tetanus peptide

- Other: Resiquimod

- Other: IFA

**Label:** Arm F (Part 1)

**Type:** EXPERIMENTAL

#### Arm Group 7

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

**Intervention Names:**

- Biological: Peptide Vaccine (LPV7) + Tetanus peptide

- Other: PolyICLC

- Other: Resiquimod

- Other: IFA

**Label:** Arm G(Part 1)

**Type:** EXPERIMENTAL

#### Arm Group 8

**Description:** Peptide Vaccine (LPV7) + IFA + PolyICLC vaccines administered in one skin location. Each vaccine will be administered in the same skin site for all 6 vaccines.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

**Intervention Names:**

- Biological: Peptide Vaccine (LPV7) + Tetanus peptide

- Other: PolyICLC

- Other: IFA

**Label:** Arm E2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm A (Part 1)

- Arm B (Part 1)

- Arm C (Part 1)

- Arm D (Part 1)

- Arm E (Part 1)

- Arm E2

- Arm F (Part 1)

- Arm G(Part 1)

**Description:** 1.5 mL administered half intradermally and half subcutaneously.

**Name:** Peptide Vaccine (LPV7) + Tetanus peptide

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Arm B (Part 1)

- Arm D (Part 1)

- Arm E (Part 1)

- Arm E2

- Arm G(Part 1)

**Description:** 1 mL administered half intradermally and half subcutaneously

**Name:** PolyICLC

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Arm C (Part 1)

- Arm D (Part 1)

- Arm F (Part 1)

- Arm G(Part 1)

**Description:** 500 mg applied to vaccine site after vaccine administration

**Name:** Resiquimod

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Arm A (Part 1)

- Arm E (Part 1)

- Arm E2

- Arm F (Part 1)

- Arm G(Part 1)

**Description:** 2 mL administered half intradermally and half subcutaneously

**Name:** IFA

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists.

Patients are evaluated by safety labs and physical exams to assess for toxicity.

**Measure:** Number of Participants With Treatment-related Adverse Events Per Study Arm

**Time Frame:** 6 months

**Description:** Levels of peptide-reactive CD8+ T cells in the peripheral blood: number of participants with T cell response to minimal epitope for CD8 T cells. This was assessed by direct (ex vivo) IFN-gamma ELIspot assay for reactivity to known minimal epitopes. To be considered positive, there had to be an increase compared to the maximum negative control target by at least 2-fold and by at least 20 IFN-gamma secreting cells per 100,000 CD8 T cells evaluated.

**Measure:** T Cell Response in Peripheral Blood Over Duration of Study Participation

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** CD4+ T cell responses to peptides in the vaccine, and their function

**Measure:** T Cell Response and Function in Peripheral Blood

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Histologically or cytologically proven Stage IIB - IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration.

  * Patients may have had melanoma from a cutaneous, mucosal or unknown primary site
  * Patients with small radiologic or clinical findings may be eligible
* Patients with treated brain metastases may be eligible if the following are true:

  * Total number of brain metastases ever is less than or equal to 3
  * The brain metastases have been completely removed by surgery or have been treated completely with stereotactic radiotherapy
  * There has been no evident growth of any brain metastases since treatment
  * No treated brain metastases is greater than 2 cm at the time of protocol entry
* Patients must have at least 1 intact axillary and/or inguinal lymph node basin
* ECOG performance status of 0-1
* Lab parameters as follows:

  * HLA-A1, A2, A3, B35, or B51
  * ANC \> 1000/mm3 and Platelets \> 100,000/mm3 and Hemoglobin \> 9 g/dL
  * AST and ALT up to 2.5 x ULN
  * Bilirubin up to 2.5 x ULN
  * Alkaline Phosphatase up to 2.5 x ULN
  * Creatinine up to 1.5 x ULN
  * HGBA1C level ≤ 7.5%

Exclusion Criteria:

* Patients with melanoma from a uveal or ocular primary site
* Patients currently receiving any systemic therapy within 4 weeks of study registration. Gamma knife or stereotactic radiosurgery must not be administered within 1 week prior to study registration. Patients who are currently receiving nitrosoureas within the preceding 6 weeks.
* Patients who have received CTLA-4, PD-1, PD-L1, CD137, or CD27 within the prior 12 months.
* Patients with known or suspected allergy to any component of the vaccine
* HIV positive or active Hepatitis C virus
* Patients receiving any of the following medications within 4 weeks are excluded:

  * Agents with immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents and topical steroids)
  * Allergy desensitization injections
  * Systemic corticosteroids, administered parenterally or orally. Inhaled steroids (e.g. Advair, Flovent, Azmacort) are not permitted. Topical corticosteroids are acceptable including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex)
  * Any growth factors (e.g. GM-CSF, G-CSF, erythropoietin).
  * Interferon therapy
  * Interleukin-2 or other interleukins
* Other investigational drugs or investigational therapy if currently receiving or have received within 1 month
* Pregnancy or the possibility of becoming pregnant during the study. And women who are breastfeeding.
* Must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. The following are not exclusionary:

  * Presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms
  * Clinical evidence of vitiligo
  * Other forms of depigmenting illness
  * Mild arthritis requiring NSAID medications
* Patients with a medical contradiction or potential problem with complying with the protocol, in the opinion of the investigator
* Patients with Class III or IV heart disease (according to NYHA classification)
* Patients with a body weight \< 110 lbs.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Houston

**Country:** United States

**Facility:** MDAnderson Cancer Center

**State:** Texas

**Zip:** 77030

**Location 2:**

**City:** Charlottesville

**Country:** United States

**Facility:** University of Virginia

**State:** Virginia

**Zip:** 22908

#### Overall Officials

**Official 1:**

**Affiliation:** University of Virginia

**Name:** Craig L Slingluff, Jr., M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Patel SP, Petroni GR, Roszik J, Olson WC, Wages NA, Chianese-Bullock KA, Smolkin M, Varhegyi N, Gaughan E, Smith KT, Haden K, Hall EH, Gnjatic S, Hwu P, Slingluff CL. Phase I/II trial of a long peptide vaccine (LPV7) plus toll-like receptor (TLR) agonists with or without incomplete Freund's adjuvant (IFA) for resected high-risk melanoma. J Immunother Cancer. 2021 Aug;9(8):e003220. doi: 10.1136/jitc-2021-003220.

**PMID:** 34413169

#### See Also Links

**Label:** NCI website

**URL:** http://www.cancer.gov/cancertopics/types/melanoma

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-07-31

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 1124978

- Type Abbrev: Prot_SAP

- Upload Date: 2021-10-03T22:52

- Date: 2019-06-11

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 1153234

- Type Abbrev: ICF

- Upload Date: 2021-10-03T22:55

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018358

- Term: Neuroendocrine Tumors

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

- ID: D000018326

- Term: Nevi and Melanomas

- ID: D000012878

- Term: Skin Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11528

- Name: Melanoma

- Relevance: HIGH

- As Found: Melanoma

- ID: M20495

- Name: Neuroendocrine Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M12448

- Name: Nevus, Pigmented

- Relevance: LOW

- As Found: Unknown

- ID: M12446

- Name: Nevus

- Relevance: LOW

- As Found: Unknown

- ID: M20470

- Name: Nevi and Melanomas

- Relevance: LOW

- As Found: Unknown

- ID: M15681

- Name: Skin Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4091

- Name: Neuroendocrine Tumor

- Relevance: LOW

- As Found: Unknown

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008545

- Term: Melanoma

### Intervention Browse Module - Ancestors

- ID: D000097912

- Term: Toll-Like Receptor Agonists

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000091369

- Term: Immunomodulating Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000007369

- Term: Interferon Inducers

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

- ID: M280480

- Name: Poly ICLC

- Relevance: HIGH

- As Found: Activity scheduling

- ID: M8740

- Name: Freund's Adjuvant

- Relevance: LOW

- As Found: Unknown

- ID: M354039

- Name: Resiquimod

- Relevance: HIGH

- As Found: Pulse Pressure

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M10407

- Name: Interferons

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000402365

- Term: Resiquimod

- ID: C000019531

- Term: Poly ICLC

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study

#### Event Groups

**Group ID:** EG000

**Title:** Arm A (Part 1)

**Deaths Num At Risk:** 5

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

IFA: 2 mL administered half intradermally and half subcutaneously

**ID:** EG000

**Other Num Affected:** 5

**Other Num at Risk:** 5

**Serious Number At Risk:** 5

**Title:** Arm A (Part 1)

**Group ID:** EG001

**Title:** Arm B (Part 1)

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 7

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

**ID:** EG001

**Other Num Affected:** 7

**Other Num at Risk:** 7

**Serious Number At Risk:** 7

**Title:** Arm B (Part 1)

**Group ID:** EG002

**Title:** Arm C (Part 1)

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 4

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after the vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration

**ID:** EG002

**Other Num Affected:** 4

**Other Num at Risk:** 4

**Serious Number At Risk:** 4

**Title:** Arm C (Part 1)

**Group ID:** EG003

**Title:** Arm D (Part 1)

**Deaths Num Affected:** 2

**Deaths Num At Risk:** 6

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration

**ID:** EG003

**Other Num Affected:** 6

**Other Num at Risk:** 6

**Serious Number At Risk:** 6

**Title:** Arm D (Part 1)

**Group ID:** EG004

**Title:** Arm E (Part 1 + 2)

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 16

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously

Except that one participant on Part 2 did not have tetanus peptide in the vaccine, and that participants vaccines were all administered at the same vaccine site.

**ID:** EG004

**Other Num Affected:** 16

**Other Num at Risk:** 16

**Serious Number At Risk:** 16

**Title:** Arm E (Part 1 + 2)

**Group ID:** EG005

**Title:** Arm F (Part 1)

**Deaths Num At Risk:** 6

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously

**ID:** EG005

**Other Num Affected:** 6

**Other Num at Risk:** 6

**Serious Number At Risk:** 6

**Title:** Arm F (Part 1)

**Group ID:** EG006

**Title:** Arm G(Part 1)

**Deaths Num Affected:** 2

**Deaths Num At Risk:** 6

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously

**ID:** EG006

**Other Num Affected:** 6

**Other Num at Risk:** 6

**Serious Number At Risk:** 6

**Title:** Arm G(Part 1)

**Frequency Threshold:** 0

#### Other Events

**Term:** Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Tinnitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Mucositis Oral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Fever

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Flu-like symptoms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Injection site reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Localized edema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Autoimmune disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Bruising

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** CTCAE (4.0)

**Term:** lymphocyte count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (4.0)

**Term:** weight loss

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (4.0)

**Term:** white blood cell decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Anorexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Generalized muscle weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Dysgeusia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Allergic rhinitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Dyspnea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Sore throat

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Hyperhidrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Pain of skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Pruritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Rash - maculopapular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** scalp pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Skin hyperpigmentation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Hypopigmentation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Skin induration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Skin ulceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Flushing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Hot flashes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Hematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Anemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Chest pain - cardiac

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Blurred vision

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Flashing lights

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Floaters

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Night blindness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Watering eyes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Dry mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Edema limbs

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Edema trunk

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Skin infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Venous Injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** CTCAE (4.0)

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Weight gain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Hyperglycemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Hyperkalemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Hypoglycemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Hyponatremia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Bone pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Paresthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Peripheral sensory neuropathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Presyncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Agitation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Renal colic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Nasal congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Dry skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Urticaria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Time Frame:** 6 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 5

**Group ID:** BG001

**Value:** 7

**Group ID:** BG002

**Value:** 4

**Group ID:** BG003

**Value:** 6

**Group ID:** BG004

**Value:** 16

**Group ID:** BG005

**Value:** 6

**Group ID:** BG006

**Value:** 6

**Group ID:** BG007

**Value:** 50

**Units:** Participants

### Group

**ID:** BG000

**Title:** Arm A (Part 1)

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

IFA: 2 mL administered half intradermally and half subcutaneously

### Group

**ID:** BG001

**Title:** Arm B (Part 1)

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

### Group

**ID:** BG002

**Title:** Arm C (Part 1)

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after the vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration

### Group

**ID:** BG003

**Title:** Arm D (Part 1)

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration

### Group

**ID:** BG004

**Title:** Arm E (Part 1 + 2)

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously.

Except that the last patient, on Part 2 received all 6 vaccines in the same site and did not receive tetanus peptide.

### Group

**ID:** BG005

**Title:** Arm F (Part 1)

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously

### Group

**ID:** BG006

**Title:** Arm G(Part 1)

**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously

### Group

**ID:** BG007

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 33

**Upper Limit:** 62

**Value:** 52

#### Measurement

**Group ID:** BG001

**Lower Limit:** 21

**Upper Limit:** 69

**Value:** 64

#### Measurement

**Group ID:** BG002

**Lower Limit:** 44

**Upper Limit:** 76

**Value:** 64

#### Measurement

**Group ID:** BG003

**Lower Limit:** 19

**Upper Limit:** 67

**Value:** 53

#### Measurement

**Group ID:** BG004

**Lower Limit:** 24

**Upper Limit:** 71

**Value:** 60

#### Measurement

**Group ID:** BG005

**Lower Limit:** 37

**Upper Limit:** 65

**Value:** 56

#### Measurement

**Group ID:** BG006

**Lower Limit:** 49

**Upper Limit:** 71

**Value:** 59

#### Measurement

**Group ID:** BG007

**Lower Limit:** 19

**Upper Limit:** 76

**Value:** 58

**Class Title:** Median Age

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 9

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 3

#### Measurement

**Group ID:** BG007

**Value:** 20

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Measurement

**Group ID:** BG004

**Value:** 7

#### Measurement

**Group ID:** BG005

**Value:** 6

#### Measurement

**Group ID:** BG006

**Value:** 3

#### Measurement

**Group ID:** BG007

**Value:** 30

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 0

#### Measurement

**Group ID:** BG007

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 6

#### Measurement

**Group ID:** BG004

**Value:** 16

#### Measurement

**Group ID:** BG005

**Value:** 6

#### Measurement

**Group ID:** BG006

**Value:** 6

#### Measurement

**Group ID:** BG007

**Value:** 50

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 0

#### Measurement

**Group ID:** BG007

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 1

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 0

#### Measurement

**Group ID:** BG007

**Value:** 1

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 0

#### Measurement

**Group ID:** BG007

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 0

#### Measurement

**Group ID:** BG007

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 0

#### Measurement

**Group ID:** BG007

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 6

#### Measurement

**Group ID:** BG004

**Value:** 15

#### Measurement

**Group ID:** BG005

**Value:** 6

#### Measurement

**Group ID:** BG006

**Value:** 6

#### Measurement

**Group ID:** BG007

**Value:** 49

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 0

#### Measurement

**Group ID:** BG007

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 0

#### Measurement

**Group ID:** BG007

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 6

#### Measurement

**Group ID:** BG004

**Value:** 16

#### Measurement

**Group ID:** BG005

**Value:** 6

#### Measurement

**Group ID:** BG006

**Value:** 6

#### Measurement

**Group ID:** BG007

**Value:** 50

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Customized
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** cls8h@virginia.edu
**Organization:** University of Virginia
**Phone:** 4349249311
**Title:** Craig Slingluff, MD; Professor, Department of Surgery; Program Director, UVA Cancer Center
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
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**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists.

Patients are evaluated by safety labs and physical exams to assess for toxicity.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** All participants enrolled and treated.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Participants With Treatment-related Adverse Events Per Study Arm
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** OG000
**Title:** Arm A (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously
**ID:** OG001
**Title:** Arm B (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after the vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration
**ID:** OG002
**Title:** Arm C (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration
**ID:** OG003
**Title:** Arm D (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma (except that the vaccines were administered to the same skin site for the one patient from cohort 2)

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously. (except that the tetanus peptide was not included in the vaccine for the one patient on this arm from cohort 2.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** OG004
**Title:** Arm E (Part 1 + Part 2)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** OG005
**Title:** Arm F (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** OG006
**Title:** Arm G(Part 1)
#### Outcome Measure 2
**Description:** Levels of peptide-reactive CD8+ T cells in the peripheral blood: number of participants with T cell response to minimal epitope for CD8 T cells. This was assessed by direct (ex vivo) IFN-gamma ELIspot assay for reactivity to known minimal epitopes. To be considered positive, there had to be an increase compared to the maximum negative control target by at least 2-fold and by at least 20 IFN-gamma secreting cells per 100,000 CD8 T cells evaluated.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** T Cell Response in Peripheral Blood Over Duration of Study Participation
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** OG000
**Title:** Arm A (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously
**ID:** OG001
**Title:** Arm B (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after the vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration
**ID:** OG002
**Title:** Arm C (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration
**ID:** OG003
**Title:** Arm D (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously

Except that one patient, on Part 2, received all 6 vaccines in the same skin site, and did not have tetanus peptide in the vaccine.
**ID:** OG004
**Title:** Arm E (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** OG005
**Title:** Arm F (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** OG006
**Title:** Arm G(Part 1)
#### Outcome Measure 3
**Description:** CD4+ T cell responses to peptides in the vaccine, and their function
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** T Cell Response and Function in Peripheral Blood
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** OG000
**Title:** Arm A (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously
**ID:** OG001
**Title:** Arm B (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after the vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration
**ID:** OG002
**Title:** Arm C (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration
**ID:** OG003
**Title:** Arm D (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously

Except that one participant on Arm E was on Part 2, where all vaccines were administered at the same vaccine site, and the tetanus peptide was not included in the vaccines.
**ID:** OG004
**Title:** Arm E (Part 1 + 2)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** OG005
**Title:** Arm F (Part 1)
##### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** OG006
**Title:** Arm G(Part 1)
### Participant Flow Module
#### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** FG000
**Title:** Arm A (Part 1)
#### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously
**ID:** FG001
**Title:** Arm B (Part 1)
#### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after the vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration
**ID:** FG002
**Title:** Arm C (Part 1)
#### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration
**ID:** FG003
**Title:** Arm D (Part 1)
#### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma (except that the vaccines were administered to the same skin site for the one patient from cohort 2)

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously. (except that the tetanus peptide was not included in the vaccine for the one patient on this arm from cohort 2.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** FG004
**Title:** Arm E (Part 1 + Part 2)
#### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** FG005
**Title:** Arm F (Part 1)
#### Group
**Description:** Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously
**ID:** FG006
**Title:** Arm G(Part 1)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** disease progression
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 16
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 6
##### Milestone
**Type:** Received at Least 3 Vaccines
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 16
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 6
##### Milestone
**Type:** COMPLETED
**Comment:** Completed all 6 vaccines
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 16
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 5
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 1
**Pre-Assignment Details:** After enrolling 49 participants across all 7 arms in accord with the study objectives, the study was amended to allow enrollment of an additional cohort on arm E (part 2) as a neoadjuvant vaccine with biopsies pre- and post-vaccine. However, only 1 patient enrolled on part 2 arm E; thus, we closed the study. Analysis of 1 patient would not satisfy the goals of that neoadjuvant component; so, we include data for the part 2 Arm E participant in Arm E for reporting purposes.
**Has Results:** True