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A Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma Recurrence | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma Recurrence

Poly-ICLC Matured DC as an Adjuvant for NY-ESO-1 and Melan-A/MART-1 Peptide Vaccination Compared to Montanide® ISA-51 VG, in Study Subjects With Melanoma in Complete Clinical Remission But at High Risk of Disease Recurrence

NCT02334735•Nina Bhardwaj

View on ClinicalTrials.gov

Summary

Vaccine adjuvants are compounds used to increase specific immune responses to antigens, but have minimal toxicity or lasting immune effects on their own. This study investigates the use of dendritic cells as an adjuvant for NY-ESO-1 and Melan-A/MART-1 peptides compared to Montanide® in study subjects with melanoma in complete clinical remission.

Detailed Description

This is a Phase II open label, randomized two-arm study to evaluate the safety, tolerability, and immunogenicity of Poly-ICLC matured DCs as an adjuvant for NY-ESO-1 and Melan-A/MART-1 peptides (ARM A; DC Vaccine) compared to Montanide® ISA-51 VG (ARM B; Montanide Vaccine), both with systemic administration of Poly-ICLC on days 1 and 2 in study subjects with melanoma in complete clinical remission but at high-risk for disease recurrence.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Willing and able to give written informed consent
•Histologic diagnosis of malignant melanoma, stages IIB-IV in radiologically confirmed complete clinical remission without clinical evidence of disease
•At least 4 weeks since surgery prior to first dosing of study agent
•Required values for initial laboratory tests:
•* Neutrophil count ≥ 1.0 x 10⁹/L
•* Platelet count ≥ 80 x 10⁹/L
•* Hemoglobin ≥ 10.0 g/dL
•* Serum creatinine ≤ 2.0 x mg/dL
•* AST/ALT ≤ 2.0 x upper limit of institutional normal
•* Serum bilirubin ≤ 2.0 x upper limit of institutional normal
+9 more criteria

Exclusion Criteria

•Serious illnesses, e.g., serious infections requiring antibiotics
•Previous bone marrow or stem cell transplant
•Study subjects with known chronic infection with HIV, hepatitis B or C. Testing will be performed if a study subject exhibits clinical signs of infection or to confirm a history of infection
•Study subjects with known autoimmune disease \[e.g. SLE, RA\] who have had significant symptoms within the past 3 years. Study subjects with vitiligo are not excluded
•Metastatic disease to the central nervous system
•Other malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, cervical carcinoma in situ, or incidental or localized prostate cancer treated with prostatectomy or radiation therapy, or stage I colon cancer. Patients with other completely resected malignancies in the prior three years and no evidence of disease will be evaluated on a case- by- case basis with eligibility determined based on discussion with the Principal Investigator.
•Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of study agents hazardous or obscure the interpretation of AEs
•Lack of availability of study subject for immunological and clinical follow up assessments
•Children \< 18 years of age
•Allergy to shellfish

Locations (2)

New York University Langone Medical Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Key Dates

Start Date

July 1, 2015

Primary Completion Date

July 15, 2020

Completion Date

July 15, 2020

Last Updated

September 15, 2022

Enrollment

ACTUAL participants

Conditions

Melanoma

Interventions

DC Vaccine

BIOLOGICAL

Montanide Vaccine

BIOLOGICAL

Poly-ICLC

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma Recurrence

Inclusion Criteria

Exclusion Criteria

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