Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Anti-Infective Agents

Vaccines

Cyclophosphamide

Poly ICLC

Monatide (IMS 3015)

Freund's Adjuvant

Immunologic Factors

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Adjuvants, Immunologic

Interferons

Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.

Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:

* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)

Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.

Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:

* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)

6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

6MHP

Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant

Montanide ISA-51

polyICLC

Craig L. Slingluff, Jr., MD

This study evaluates whether it is safe to administer a peptide vaccine in combination with different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study will also evaluate the effects of the combination of the peptide vaccine and the adjuvants on the immune system. The investigators will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tissue from the sites of vaccination.

Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma

A Trial to Evaluate the Immunogenicity and Safety of a Melanoma Helper Peptide Vaccine Plus Novel Adjuvant Combinations (MEL63)

Treatment-related adverse events, by CTCAE v4, Dose-limiting toxicities.

CD4+ T cell responses to 6 MHP: durable helper T cell response to 6MHP at 2 or more consecutive timepoints in the PBMC.

increased infiltration of CD4+ and CD8+ T lymphocytes into melanoma metastases

CD8+ T cell responses to defined melanoma antigens

Ludwig Institute for Cancer Research

Cancer Research Institute, New York City

Craig L Slingluff, Jr

Director, Human Immune Therapy Center

The study will be monitored continuously for treatment-related adverse events.

A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria:

* ≥ Grade 3
* ≥ Grade 1 ocular adverse events as defined below
* ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.

Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.

6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant

Arm A:6MHP + Montanide ISA-51

Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:

* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)

  6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant

Cyclophosphamide: Cyclophosphamide, systemic adjuvant

Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide

Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.

6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant

polyICLC: polyICLC, local adjuvant

Arm C:6MHP + polyICLC + Montanide ISA-51

Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:

* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)

  6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant

polyICLC: polyICLC, local adjuvant

Cyclophosphamide: Cyclophosphamide, systemic adjuvant

Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Each participant was staged according to AJCC version 7 criteria at the time of study enrollment. Risk of death is generally higher for stage III than stage II, and within each stage, risk is higher for stage C than B than A. For those enrolled within 6 months of definitive therapy of the original diagnosis, the stage at diagnoses is used. For those enrolled after a subsequent recurrence or metastasis, the stage at recurrence was used.

AJCC stage (v7)

Craig Slingluff, MD, Professor of Surgery

All 48 participants , including 47 on part 1 and 1 on part 2.

Number of Participants With Adverse Events

All ennrolled and treated patients on Parts 1 and 2 of the study.

Immunogenicity-CD4+ T Cell Responses

CD8 T cells per mm2 in tumor pre-vaccine (day 0)

CD8 T cells per mm2 in tumor day 22

CD4 T cells per mm2 of tumor prevaccine (day 0)

CD4 T cells per mm2 tumor day 22

One patient enrolled on Part 2, was on Arm D.

Immunogenicity-modification of the Tumor Microenvironment (Part 2 Only)

Data were not collected for this endpoint. Funding for this trial has ended.

Immunogenicity-CD8+ T Cell Responses

Overall Study

Resiquimod

Immunomodulating Agents

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 + 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 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 + 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 + 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 + 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 + 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) + 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.

1.5 mL administered half intradermally and half subcutaneously.

Peptide Vaccine (LPV7) + Tetanus peptide

1 mL administered half intradermally and half subcutaneously

PolyICLC

500 mg applied to vaccine site after vaccine administration

2 mL administered half intradermally and half subcutaneously

Craig L Slingluff, Jr., M.D.

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.

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

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

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.

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.

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

University of Virginia

Professor, Department of Surgery

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

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

Arm A (Part 1)

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

Arm B (Part 1)

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

Arm C (Part 1)

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

Arm D (Part 1)

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.

Arm E (Part 1 + 2)

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

Arm F (Part 1)

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

Arm G(Part 1)

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.

Median Age

Age, Customized

Craig Slingluff, MD; Professor, Department of Surgery; Program Director, UVA Cancer Center

BLOOD/LYMPHATIC - Other

EAR/LABYRINTH - Tinnitus

GASTROINTESTINAL - Constipation

GASTROINTESTINAL - Diarrhea

GASTROINTESTINAL - Mucositis oral

GASTROINTESTINAL - Nausea

GASTROINTESTINAL - Other

GASTROINTESTINAL - Vomiting

GENERAL AND ADMINISTRATION SITE - Chills

GENERAL AND ADMINISTRATION SITE - Fatigue

GENERAL AND ADMINISTRATION SITE - Fever

GENERAL AND ADMINISTRATION SITE - Flu like symptoms

GENERAL AND ADMINISTRATION SITE - Injection site reaction

GENERAL AND ADMINISTRATION SITE - Localized edema

GENERAL AND ADMINISTRATION SITE - Other

GENERAL AND ADMINISTRATION SITE - Pain

IMMUNE SYSTEM - Autoimmune disorder

INJURY/POISONING/PROCEDURAL - Bruising

INVESTIGATIONS - Lymphocyte count decreased

INVESTIGATIONS - Weight loss

INVESTIGATIONS - White blood cell decreased

METABOLISM/NUTRITION - Anorexia

MUSCULOSKELETAL/CONNECTIVE TISSUE - Arthralgia

MUSCULOSKELETAL/CONNECTIVE TISSUE - Generalized muscle weakness

MUSCULOSKELETAL/CONNECTIVE TISSUE - Myalgia

MUSCULOSKELETAL/CONNECTIVE TISSUE - Pain in extremity

MUSCULOSKELETAL/CONNECTIVE TISSUE - Other

NERVOUS SYSTEM - Dizziness

NERVOUS SYSTEM - Dysgeusia

NERVOUS SYSTEM - Headache

PSYCHIATRIC - Anxiety

RESPIRATORY/THORACIC/MEDIASTINAL - Allergic rhinitis

RESPIRATORY/THORACIC/MEDIASTINAL - Cough

RESPIRATORY/THORACIC/MEDIASTINAL - Dyspnea

RESPIRATORY/THORACIC/MEDIASTINAL - Sore throat

SKIN/SUBCUTANEOUS TISSUE - Hyperhidrosis

SKIN/SUBCUTANEOUS TISSUE - Pain of skin

SKIN/SUBCUTANEOUS TISSUE - Pruritus

SKIN/SUBCUTANEOUS TISSUE - Rash maculo-papular

SKIN/SUBCUTANEOUS TISSUE - Scalp pain

SKIN/SUBCUTANEOUS TISSUE - Skin hyperpigmentation

SKIN/SUBCUTANEOUS TISSUE - Skin hypopigmentation

SKIN/SUBCUTANEOUS TISSUE - Skin induration

SKIN/SUBCUTANEOUS TISSUE - Skin ulceration

VASCULAR - Flushing

VASCULAR - Hot flashes

VASCULAR - Other

DLTs

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

Arm E (Part 1 + Part 2)

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

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.

Arm E (Part 1)

T Cell Response in Peripheral Blood Over Duration of Study Participation

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.

T Cell Response and Function in Peripheral Blood

Vaccines will be administered subcutaneously, intradermally or transdermally 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.

Cohort 1 will be divided into three sub-groups and will receive:

* Group 1a: MELITAC 12.1 + lipopolysaccharide (LPS)
* Group 1b: MELITAC 12.1 + lipopolysaccharide (LPS) + Montanide adjuvant with vaccination #1
* Group 1c: MELITAC 12.1 + lipopolysaccharide (LPS) adjuvant + Montanide adjuvant with all vaccinations

MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS)

Cohort 2 will be divided into three sub-groups and will receive:

* Group 2a: MELITAC 12.1 + polyICLC adjuvant
* Group 2b: MELITAC 12.1 + polyICLC adjuvant + Montanide adjuvant with vaccination #1
* Group 2c: MELITAC 12.1 + polyICLC adjuvant + Montanide adjuvant with all vaccinations

MELITAC 12.1 + Montanide ISA-51 + polyICLC

Craig L Slingluff, MD

The purpose of this study is to learn the effects an experimental vaccine (MELITAC 12.1) combined with other substances called lipopolysaccharide (LPS; endotoxin), polyICLC, and Montanide ISA-51. The LPS, polyICLC, and Montanide ISA-51 are included with the vaccine to test whether they have an effect on the MELITAC 12.1 vaccine. The study will also look at whether the experimental vaccine and these drugs cause any changes to the immune system.

Goals:

1. To determine the safety of intradermal and subcutaneous injection of lipopolysaccharide (LPS) as a vaccine adjuvant with a multipeptide vaccine.
2. To obtain preliminary data on whether administration of a multipeptide vaccine plus each of 2 TLR agonists is immunogenic with or without Incomplete Freund's Adjuvant (IFA)
3. To obtain preliminary data on whether addition of either of 2 toll-like receptor (TLR) agonists improve the persistence of circulating CD8+ T cell responses to vaccination with a multipeptide vaccine.
4. To determine the local and systemic toxicities of administration of a multipeptide vaccine with each of 2 TLR agonists, and with or without incomplete Freund's adjuvant.
5. To determine the cytokine and chemokine profile of the vaccine-site microenvironment week 1 after injection of a multipeptide vaccine and each of 2 TLR agonists, with or without IFA.
6. To obtain preliminary data on T cell activation status and apoptosis in the vaccine site microenvironment (VSME) as a function of vaccine adjuvant.
7. To assess whether circulating CD8 T cells induced by vaccination express different homing receptor profiles (CLA, CXCR3, α4β1 integrin, α4β7 integrin).
8. To evaluate dendritic cell activation and function in sentinel immunized nodes draining the site of vaccination, for production of IDO, arginase, IL10, IL12.
9. To characterize MyD88 expression in dendritic cells infiltrating vaccination sites.
10. To identify regulatory processes in the vaccination site.

Design: This is an open-label, randomized, pilot study of cellular and molecular events at the cutaneous site of immunization with a multipeptide vaccine. This and related peptide vaccines have been associated with immunologic efficacy in a majority of participants and have been associated with clinical tumor regressions in some participants. The maximum number of participants accrued will be 51.

Endpoints:

Primary:

* Safety, with measures of adverse events, locally and systemically
* CD8+ and CD4+ peptide-reactive T cell responses among lymphocytes in the peripheral blood and in sentinel immunized nodes (SIN)

Secondary:

* Toll-like receptor signaling in the replicate immunization site
* CCR and integrin expression on vaccine induced T cells in the peripheral blood and at the replicate immunization site
* Th1, Th2, and Th17 profiles of T cells in the vaccination site and SIN as measured by cytokine expression (IFNγ, IL-2, TNFα, IL-4, IL-5, IL-10, IL-17, IL-23), and nuclear expression of transcription factors (T-bet, GATA3, RORγt) by immunohistochemistry.
* Chemokines CXCL9, 10, and 11; CCL19, CCL21, CXCL12, CXCL13 in the vaccine site microenvironment.
* Markers of activation, regulation, and apoptosis on CD4 and CD8 T cells in the vaccine site and SIN: CD69, Ki67, FoxP3, and TUNEL staining.
* Homing receptors expressed by antigen-reactive (tetramer-positive) T cells induced by vaccination, in the circulation and SIN.
* MyD88 expression in the VSME and SIN
* Regulatory processes in the immunization site and SIN

  * Regulatory T cells (CD4+CD25hi FoxP3+)
  * Myeloid suppressor cells
  * Indole-amine dioxygenase
  * PD-1, B7-H1
  * IL-10 and IL-12 expression by dendritic cells (DC)

A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients

A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients, With Evaluation of the Injection Site Microenvironment

* Regulatory T cells (CD4+CD25hi FoxP3+)
* Myeloid suppressor cells
* Indole-amine dioxygenase
* PD-1, B7-H1
* IL-10 and IL-12 expression by dendritic cells (DC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma	NCT02425306	Melanoma	6MHP Montanide ISA-5... polyICLC Cyclophosphamid...	18 Years -	University of Virginia
Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma	NCT02425306	Melanoma	6MHP Montanide ISA-5... polyICLC Cyclophosphamid...	18 Years -	University of Virginia
Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists	NCT02126579	Melanoma Metastatic Mela... Mucosal Melanom...	Peptide Vaccine... PolyICLC Resiquimod IFA	18 Years -	University of Virginia
A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients	NCT01585350	Melanoma	MELITAC 12.1 + ... MELITAC 12.1 + ...	18 Years -	University of Virginia
Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma	NCT03617328	Melanoma	6MHP Montanide ISA-5... polyICLC CDX-1127	18 Years -	University of Virginia
A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients	NCT01585350	Melanoma	MELITAC 12.1 + ... MELITAC 12.1 + ...	18 Years -	University of Virginia
Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma)	NCT04364230	Melanoma Ocular Melanoma Uveal Melanoma	6MHP NeoAg-mBRAF PolyICLC CDX-1140	18 Years -	University of Virginia
Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors	NCT04116320	Melanoma Breast Cancer Merkel Cell Car... Squamous Cell C... Non Small Cell ... Cervical Cancer Urothelial Carc... Ovarian Cancer Hepatocellular ... Small-cell Lung... Microsatellite ... Gastric Cancer Esophageal Canc...	Echopulse Poly ICLC Standard of Car...	18 Years -	University of Virginia
Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma)	NCT04364230	Melanoma Ocular Melanoma Uveal Melanoma	6MHP NeoAg-mBRAF PolyICLC CDX-1140	18 Years -	University of Virginia

Spots Global Cancer Trial Database for polyiclc

Every month we try and update this database with for polyiclc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for polyiclc

Every month we try and update this database with for polyiclc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for polyiclc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.